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出境医 / 临床实验 / Trial to Assess Chelation Therapy in Critical Limb Ischemia (TACT3a)

Trial to Assess Chelation Therapy in Critical Limb Ischemia (TACT3a)

Study Description
Brief Summary:
TACT3a is a double blind, placebo-controlled, randomized trial to test a novel therapy, edetate disodium-based chelation of environmentally acquired toxic metals, to reduce cardiovascular events including amputation in high-risk diabetic patients.

Condition or disease Intervention/treatment Phase
Critical Limb Ischemia Diabetes Drug: Edetate Disodium Other: Placebo Phase 3

Detailed Description:

TACT3a is a double blind, placebo-controlled, randomized trial to test a novel therapy, edetate disodium-based chelation of environmentally acquired toxic metals, to reduce cardiovascular events including amputation in high-risk diabetic patients.

The study plans to enroll 50 patients with diabetes and critical limb ischemia (CLI) to prevent the major cardiovascular endpoints of major amputation, coronary revascularization, stroke, Myocardial Infarction (MI), or death (all-cause) during an average 1.25 years of follow-up. Patients will be randomly assigned to chelation or placebo with a 3:2 (30 active, 20 placebo) allocation ratio. Treatment will consist of 40 active or placebo infusions over 30 weeks. Active therapy will be the same edetate disodium-based infusion used safely and successfully in a previous published study, Trial to Assess Chelation Therapy (TACT). Baseline and post infusion urine metals will be collected. Following the final infusion, patients will be contacted quarterly until the end of the study.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: double-blind
Primary Purpose: Treatment
Official Title: Trial to Assess Chelation Therapy in Critical Limb Ischemia
Actual Study Start Date : March 19, 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : March 2023
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Active
edetate disodium (EDTA)dff active infusion
 Drug: Edetate Disodium
The solution contains up to 3 g of edetate disodium adjusted based on creatinine clearance, 2 g of magnesium chloride, 100 mg of procaine hydrochloride, 2500 U of heparin, 7 g of ascorbate, 2 milliequivalent (mEq) potassium chloride (KCl), 840 mg sodium bicarbonate, 250 mg pantothenic acid, 100 mg of thiamine, 100 mg of pyridoxine, and sterile water to complete 500 mL.
Other Name: TACT EDTA infusion
Placebo Comparator: Placebo
Placebo infusion
 Other: Placebo
Placebo infusions consist of 500 ml normal saline.
Outcome Measures
Primary Outcome Measures :
  1. Prevention of major cardiovascular endpoints [ Time Frame: 3 years (average follow-up 1.25 years) ]
    Major cardiovascular endpoints include: coronary revascularization, stroke, MI, death (all-cause), or major amputation


Secondary Outcome Measures :
  1. Amputations [ Time Frame: 3 years (average follow-up 1.25 years) ]
    • Major amputations due to vascular disease. Major amputations are defined as any procedure that results in amputation at the level above the ankle. 49, 50
    • Total amputations due to vascular disease

  2. Heart failure [ Time Frame: 3 years (average follow-up 1.25 years) ]
    • Heart failure hospitalizations or prolonged (>12 hours) ER stay for heart failure

  3. Changes in Pain severity [ Time Frame: 3 years (average follow-up 1.25 years) ]
    • Any changes in pain will be recorded at baseline, infusions 10, 20, 40 (or final), and end of study recorded using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference- Short Form 8a. The scale range is 1 to 5, with 1 being the best outcome (no pain interference) and 5 the worse (very much interference)

  4. Urine Metals [ Time Frame: 1 year ]
    • Changes in urine metal levels measured at the Metals Core Lab and measured at baseline and infusion 40 (or final).

  5. Changes in Quality of Life [ Time Frame: 3 years (average follow-up 1.25 years) ]
    • Health-related quality of life (QOL) changes recorded at baseline, 10, 20, 40 (or final), and end of study using the 36-Item Short Form Health Survey (SF-36 v2). The 36 questions assess eight health-related concepts: physical functioning, role limitations due to physical health problems (role physical), bodily pain, general health, energy levels/fatigue (vitality), social functioning, role limitations due to emotional problems (role emotional), and psychological distress (mental health). The scales vary depending on the question asked.The survey will be used to detect change (better or worse) in participants' health state over the course of the study.

  6. Wound Severity [ Time Frame: 3 years (average follow-up 1.25 years) ]
    Wound severity (quantified and imaged with HIPAA-compliant photography) photographed at baseline 10, 20, 40 (or final), and end of study

  7. Changes in skin perfusion pressure in the ankle [ Time Frame: 3 years (average follow-up 1.25 years) ]
    • Changes in skin perfusion pressure will be measured at 10, 20, 40 (or final), and end of study, using the ankle-brachial index (mmHg)

  8. Changes in skin perfusion pressure in the toe [ Time Frame: 3 years (average follow-up 1.25 years) ]
    • Changes in skin perfusion pressure will be measured at 10, 20, 40 (or final), and end of study, using the toe-brachial index (mmHg).

  9. Changes in PAD Quality of Life [ Time Frame: 3 years (average follow-up 1.25 years) ]
    • PAD related quality of life (QOL) changes recorded at baseline, 10, 20, 40 (or final), and end of study using the Peripheral Artery Questionnaire (PAQ), which is a 20-item questionnaire measuring physical limitations, symptoms, symptom stability, treatment satisfaction, quality of life, and social function. The scales vary depending on the question asked. The survey will be used to detect change (better or worse) in participants responses over the course of the study.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 50 years
  • History of diabetes, defined as medical record evidence or patient report of currently using insulin or oral hypoglycemic agents, or with a history of fasting blood glucose measurement of 126 mg/dL or higher, or a history of HbA1c of 6.5% or higher.
  • Significant stenosis (≥ 75%) of two or more infra-popliteal arteries in the affected limb as verified by at least one imaging technique (angiography, magnetic resonance angiogram, coronary computed tomography angiogram, or doppler examination) within 6 months prior to enrollment;

  • History of CLI defined as moderate or high-risk infra-popliteal chronic critical limb ischemia (Rutherford Clinical Severity Score 4 or 5) defined as:

    • The presence of rest pain or non-healing ulceration or gangrene for at least 2 weeks plus documentation of severely compromised tissue perfusion:
    • If there is tissue loss, a resting ankle systolic pressure of ≤ 60 mmHg in the affected limb; or a resting toe systolic pressure of ≤ 40 mmHg or a tissue perfusion pressure (TPP) <40 mmHg.
    • If there is no tissue loss, a resting ankle pressure of ≤ 50 mmHg or resting toe systolic pressure of ≤ 30 mmHg or a tissue perfusion pressure (TPP) < 30 mmHg.
  • Not a candidate or a failed candidate for surgical or transcatheter revascularization;
  • Able to give informed consent.

Exclusion Criteria:

  • Arterial insufficiency in the lower extremity as the result of a non-atherosclerotic disorder.
  • Subjects with evidence of active infection (e.g., cellulitis, osteomyelitis) or deep ulceration exposing bone or tendon or extensive heel ulceration
  • Subjects with extensive gangrene extending above the Metatarsophalangeal (MT) joint
  • Subjects in whom there is severe pain at rest uncontrollable with pain medications
  • Prior intravenous chelation therapy consisting of > 1 infusion within 5 years; if only 1 infusion took place, patient cannot be enrolled for at least 12 months after said infusion.
  • Oral chelation with an FDA-approved chelating agent within 2 years
  • Allergy to any components of the study drug
  • Coronary or carotid revascularization within 3 months
  • Planned leg revascularization within 1 month of enrollment
  • Symptomatic or clinically evident acute heart failure
  • Heart failure hospitalization within 3 months
  • Blood pressure >160/100
  • No venous access
  • Estimated glomerular filtration ratee (GFR) < 30 mL/min per 1.73 m2 or lower (CKD stages 1-3) calculated with the Modification of Diet in Renal Disease Study (MDRD) equation
  • Known or suspected acute kidney injury using prevalent Kidney Disease: Improving Global Outcomes (KDIGO) criteria
  • Platelet count <100,000/mm3
  • Cigarette smoking within the last 3 months
  • Liver disease or Alanine aminotransferase (ALT), aspartate aminotransferase (AST) > 2.0 times the upper limit of normal (this will require clearance by the Study PI)
  • Diseases of copper, iron, or calcium metabolism (other than osteopenia or osteoporosis, or simple iron deficiency). These require evaluation by the Study PI
  • Inability to tolerate the study-required fluid load
  • Other medical condition likely to affect patient survival within 3 years
  • Women of child-bearing potential
  • Any factor that suggests that the potential participant will not be able to adhere to the protocol.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Francisco Ujueta, MD 305-674-2162 Francisco.Ujueta@msmc.com
Contact: Beatriz Acevedo 305-674-2162 Beatriz.Acevedo@msmc.com

Locations
Layout table for location information
United States, Florida
Mount Sinai Medical Center Recruiting
Miami Beach, Florida, United States, 33140
Contact: Francisco Ujueta, MD    305-674-2162    Francisco.Ujueta@msmc.com   
Contact: Beatriz Acevedo    305-674-2162    Beatriz.Acevedo@msmc.com   
Sponsors and Collaborators
Mt. Sinai Medical Center, Miami
Investigators
Layout table for investigator information
Principal Investigator: Gervasio Lamas, MD Icahn School of Medicine at Mount Sinai
Tracking Information
First Submitted Date  ICMJE May 27, 2019
First Posted Date  ICMJE June 11, 2019
Last Update Posted Date September 2, 2020
Actual Study Start Date  ICMJE March 19, 2019
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 9, 2019) 		Prevention of major cardiovascular endpoints [ Time Frame: 3 years (average follow-up 1.25 years) ]
Major cardiovascular endpoints include: coronary revascularization, stroke, MI, death (all-cause), or major amputation
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2019)
  • Amputations [ Time Frame: 3 years (average follow-up 1.25 years) ]
    • Major amputations due to vascular disease. Major amputations are defined as any procedure that results in amputation at the level above the ankle. 49, 50
    • Total amputations due to vascular disease
  • Heart failure [ Time Frame: 3 years (average follow-up 1.25 years) ]
    • Heart failure hospitalizations or prolonged (>12 hours) ER stay for heart failure
  • Changes in Pain severity [ Time Frame: 3 years (average follow-up 1.25 years) ]
    • Any changes in pain will be recorded at baseline, infusions 10, 20, 40 (or final), and end of study recorded using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference- Short Form 8a. The scale range is 1 to 5, with 1 being the best outcome (no pain interference) and 5 the worse (very much interference)
  • Urine Metals [ Time Frame: 1 year ]
    • Changes in urine metal levels measured at the Metals Core Lab and measured at baseline and infusion 40 (or final).
  • Changes in Quality of Life [ Time Frame: 3 years (average follow-up 1.25 years) ]
    • Health-related quality of life (QOL) changes recorded at baseline, 10, 20, 40 (or final), and end of study using the 36-Item Short Form Health Survey (SF-36 v2). The 36 questions assess eight health-related concepts: physical functioning, role limitations due to physical health problems (role physical), bodily pain, general health, energy levels/fatigue (vitality), social functioning, role limitations due to emotional problems (role emotional), and psychological distress (mental health). The scales vary depending on the question asked.The survey will be used to detect change (better or worse) in participants' health state over the course of the study.
  • Wound Severity [ Time Frame: 3 years (average follow-up 1.25 years) ]
    Wound severity (quantified and imaged with HIPAA-compliant photography) photographed at baseline 10, 20, 40 (or final), and end of study
  • Changes in skin perfusion pressure in the ankle [ Time Frame: 3 years (average follow-up 1.25 years) ]
    • Changes in skin perfusion pressure will be measured at 10, 20, 40 (or final), and end of study, using the ankle-brachial index (mmHg)
  • Changes in skin perfusion pressure in the toe [ Time Frame: 3 years (average follow-up 1.25 years) ]
    • Changes in skin perfusion pressure will be measured at 10, 20, 40 (or final), and end of study, using the toe-brachial index (mmHg).
  • Changes in PAD Quality of Life [ Time Frame: 3 years (average follow-up 1.25 years) ]
    • PAD related quality of life (QOL) changes recorded at baseline, 10, 20, 40 (or final), and end of study using the Peripheral Artery Questionnaire (PAQ), which is a 20-item questionnaire measuring physical limitations, symptoms, symptom stability, treatment satisfaction, quality of life, and social function. The scales vary depending on the question asked. The survey will be used to detect change (better or worse) in participants responses over the course of the study.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2019)
  • Amputations [ Time Frame: 3 years (average follow-up 1.25 years) ]
    • Major amputations due to vascular disease. Major amputations are defined as any procedure that results in amputation at the level above the ankle. 49, 50
    • Total amputations due to vascular disease
  • Heart failure [ Time Frame: 3 years (average follow-up 1.25 years) ]
    • Heart failure hospitalizations or prolonged (>12 hours) ER stay for heart failure
  • Changes in Pain severity [ Time Frame: 3 years (average follow-up 1.25 years) ]
    • Any changes in pain will be recorded at baseline, infusions 10, 20, 40 (or final), and end of study recorded using the NIH Toolbox Questionnaire
  • Urine Metals [ Time Frame: 1 year ]
    • Changes in urine metal levels measured at the Metals Core Lab and measured at baseline and infusion 40 (or final).
  • Changes in Quality of Life [ Time Frame: 3 years (average follow-up 1.25 years) ]
    • Health-related quality of life (QOL) changes recorded at baseline, 10, 20, 40 (or final), and end of study using SF-36
  • Wound Severity [ Time Frame: 3 years (average follow-up 1.25 years) ]
    Wound severity (quantified and imaged with HIPAA-compliant photography) photographed at baseline 10, 20, 40 (or final), and end of study
  • Changes in skin perfusion pressure [ Time Frame: 3 years (average follow-up 1.25 years) ]
    • Changes in skin perfusion pressure will be measured at 10, 20, 40 (or final), and end of study, using the ankle-brachial and toe-brachial indices.
  • Changes in PAD Quality of Life [ Time Frame: 3 years (average follow-up 1.25 years) ]
    • PAD related quality of life (QOL) changes recorded at baseline, 10, 20, 40 (or final), and end of study using the PAD Questionnaire
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial to Assess Chelation Therapy in Critical Limb Ischemia
Official Title  ICMJE Trial to Assess Chelation Therapy in Critical Limb Ischemia
Brief Summary TACT3a is a double blind, placebo-controlled, randomized trial to test a novel therapy, edetate disodium-based chelation of environmentally acquired toxic metals, to reduce cardiovascular events including amputation in high-risk diabetic patients.
Detailed Description

TACT3a is a double blind, placebo-controlled, randomized trial to test a novel therapy, edetate disodium-based chelation of environmentally acquired toxic metals, to reduce cardiovascular events including amputation in high-risk diabetic patients.

The study plans to enroll 50 patients with diabetes and critical limb ischemia (CLI) to prevent the major cardiovascular endpoints of major amputation, coronary revascularization, stroke, Myocardial Infarction (MI), or death (all-cause) during an average 1.25 years of follow-up. Patients will be randomly assigned to chelation or placebo with a 3:2 (30 active, 20 placebo) allocation ratio. Treatment will consist of 40 active or placebo infusions over 30 weeks. Active therapy will be the same edetate disodium-based infusion used safely and successfully in a previous published study, Trial to Assess Chelation Therapy (TACT). Baseline and post infusion urine metals will be collected. Following the final infusion, patients will be contacted quarterly until the end of the study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:
double-blind
Primary Purpose: Treatment
Condition  ICMJE
  • Critical Limb Ischemia
  • Diabetes
Intervention  ICMJE
  • Drug: Edetate Disodium
    The solution contains up to 3 g of edetate disodium adjusted based on creatinine clearance, 2 g of magnesium chloride, 100 mg of procaine hydrochloride, 2500 U of heparin, 7 g of ascorbate, 2 milliequivalent (mEq) potassium chloride (KCl), 840 mg sodium bicarbonate, 250 mg pantothenic acid, 100 mg of thiamine, 100 mg of pyridoxine, and sterile water to complete 500 mL.
    Other Name: TACT EDTA infusion
  • Other: Placebo
    Placebo infusions consist of 500 ml normal saline.
Study Arms  ICMJE
  • Active Comparator: Active
    edetate disodium (EDTA)dff active infusion
    Intervention: Drug: Edetate Disodium
  • Placebo Comparator: Placebo
    Placebo infusion
    Intervention: Other: Placebo
Publications *
  • Arenas IA, Navas-Acien A, Ergui I, Lamas GA. Enhanced vasculotoxic metal excretion in post-myocardial infarction patients following a single edetate disodium-based infusion. Environ Res. 2017 Oct;158:443-449. doi: 10.1016/j.envres.2017.06.039. Epub 2017 Jul 6.
  • Lamas GA, Goertz C, Boineau R, Mark DB, Rozema T, Nahin RL, Drisko JA, Lee KL. Design of the Trial to Assess Chelation Therapy (TACT). Am Heart J. 2012 Jan;163(1):7-12. doi: 10.1016/j.ahj.2011.10.002.
  • Escolar E, Lamas GA, Mark DB, Boineau R, Goertz C, Rosenberg Y, Nahin RL, Ouyang P, Rozema T, Magaziner A, Nahas R, Lewis EF, Lindblad L, Lee KL. The effect of an EDTA-based chelation regimen on patients with diabetes mellitus and prior myocardial infarction in the Trial to Assess Chelation Therapy (TACT). Circ Cardiovasc Qual Outcomes. 2014 Jan;7(1):15-24. doi: 10.1161/CIRCOUTCOMES.113.000663. Epub 2013 Nov 19.
  • Ujueta F, Arenas IA, Diaz D, Yates T, Beasley R, Navas-Acien A, Lamas GA. Cadmium level and severity of peripheral artery disease in patients with coronary artery disease. Eur J Prev Cardiol. 2019 Sep;26(13):1456-1458. doi: 10.1177/2047487318796585. Epub 2018 Aug 28.
  • Ujueta F, Arenas IA, Escolar E, Diaz D, Boineau R, Mark DB, Golden P, Lindblad L, Kim H, Lee KL, Lamas GA. The effect of EDTA-based chelation on patients with diabetes and peripheral artery disease in the Trial to Assess Chelation Therapy (TACT). J Diabetes Complications. 2019 Jul;33(7):490-494. doi: 10.1016/j.jdiacomp.2019.04.005. Epub 2019 Apr 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 9, 2019) 		50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2023
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≥ 50 years
  • History of diabetes, defined as medical record evidence or patient report of currently using insulin or oral hypoglycemic agents, or with a history of fasting blood glucose measurement of 126 mg/dL or higher, or a history of HbA1c of 6.5% or higher.
  • Significant stenosis (≥ 75%) of two or more infra-popliteal arteries in the affected limb as verified by at least one imaging technique (angiography, magnetic resonance angiogram, coronary computed tomography angiogram, or doppler examination) within 6 months prior to enrollment;

  • History of CLI defined as moderate or high-risk infra-popliteal chronic critical limb ischemia (Rutherford Clinical Severity Score 4 or 5) defined as:

    • The presence of rest pain or non-healing ulceration or gangrene for at least 2 weeks plus documentation of severely compromised tissue perfusion:
    • If there is tissue loss, a resting ankle systolic pressure of ≤ 60 mmHg in the affected limb; or a resting toe systolic pressure of ≤ 40 mmHg or a tissue perfusion pressure (TPP) <40 mmHg.
    • If there is no tissue loss, a resting ankle pressure of ≤ 50 mmHg or resting toe systolic pressure of ≤ 30 mmHg or a tissue perfusion pressure (TPP) < 30 mmHg.
  • Not a candidate or a failed candidate for surgical or transcatheter revascularization;
  • Able to give informed consent.

Exclusion Criteria:

  • Arterial insufficiency in the lower extremity as the result of a non-atherosclerotic disorder.
  • Subjects with evidence of active infection (e.g., cellulitis, osteomyelitis) or deep ulceration exposing bone or tendon or extensive heel ulceration
  • Subjects with extensive gangrene extending above the Metatarsophalangeal (MT) joint
  • Subjects in whom there is severe pain at rest uncontrollable with pain medications
  • Prior intravenous chelation therapy consisting of > 1 infusion within 5 years; if only 1 infusion took place, patient cannot be enrolled for at least 12 months after said infusion.
  • Oral chelation with an FDA-approved chelating agent within 2 years
  • Allergy to any components of the study drug
  • Coronary or carotid revascularization within 3 months
  • Planned leg revascularization within 1 month of enrollment
  • Symptomatic or clinically evident acute heart failure
  • Heart failure hospitalization within 3 months
  • Blood pressure >160/100
  • No venous access
  • Estimated glomerular filtration ratee (GFR) < 30 mL/min per 1.73 m2 or lower (CKD stages 1-3) calculated with the Modification of Diet in Renal Disease Study (MDRD) equation
  • Known or suspected acute kidney injury using prevalent Kidney Disease: Improving Global Outcomes (KDIGO) criteria
  • Platelet count <100,000/mm3
  • Cigarette smoking within the last 3 months
  • Liver disease or Alanine aminotransferase (ALT), aspartate aminotransferase (AST) > 2.0 times the upper limit of normal (this will require clearance by the Study PI)
  • Diseases of copper, iron, or calcium metabolism (other than osteopenia or osteoporosis, or simple iron deficiency). These require evaluation by the Study PI
  • Inability to tolerate the study-required fluid load
  • Other medical condition likely to affect patient survival within 3 years
  • Women of child-bearing potential
  • Any factor that suggests that the potential participant will not be able to adhere to the protocol.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Francisco Ujueta, MD 305-674-2162 Francisco.Ujueta@msmc.com
Contact: Beatriz Acevedo 305-674-2162 Beatriz.Acevedo@msmc.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03982693
Other Study ID Numbers  ICMJE 19-05-H-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gervasio Lamas, MD, Mt. Sinai Medical Center, Miami
Study Sponsor  ICMJE Mt. Sinai Medical Center, Miami
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gervasio Lamas, MD Icahn School of Medicine at Mount Sinai
PRS Account Mt. Sinai Medical Center, Miami
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP