4006-776-356 出国就医服务电话

免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Computed Tomography Coronary Angiography for the Prevention of Myocardial Infarction (The SCOT-HEART 2 Trial) (SCOT-HEART 2)

Computed Tomography Coronary Angiography for the Prevention of Myocardial Infarction (The SCOT-HEART 2 Trial) (SCOT-HEART 2)

Study Description
Brief Summary:
It is hypothesised that, in individuals being considered for cardiovascular preventative therapy, computed tomography coronary angiography guided management will reduce the future risk of coronary heart disease death or non-fatal myocardial infarction compared to management guided by the current standard of care, a cardiovascular risk score.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Diagnostic Test: Computed tomography coronary angiography Other: ASSIGN Score Not Applicable

Detailed Description:
Prevention of cardiovascular disease is currently guided by probabilistic risk scores that both over and under treat individuals, commit most middle-aged people to pharmacotherapy, and have little evidence base. It has been demonstrated that use of computed tomography coronary angiography (CTCA) is associated with changes in the diagnosis and treatment of patients presenting with stable chest pain, and that this leads to a marked reduction in the future risk of myocardial infarction. Importantly, the proportionate reduction in coronary events was most marked in those with non-anginal chest pain irrespective of their cardiovascular risk score which again demonstrated poor discrimination. The research team propose a randomised controlled trial of at least 6,000 middle-aged individuals at risk of cardiovascular disease that will compare these two strategies of targeting preventative therapies: a probabilistic cardiovascular risk score, and screening with CTCA. This trial will determine if CTCA guided management will be associated with better targeted intervention, prevent over medicating the general population, and result in fewer future coronary heart disease events than the current standard of care using a cardiovascular risk score.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Computed Tomography Coronary Angiography for the Prevention of Myocardial Infarction (The SCOT-HEART 2 Trial)
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : October 1, 2023
Estimated Study Completion Date : April 1, 2027
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Computed tomography coronary angiography Diagnostic Test: Computed tomography coronary angiography
CTCA >64 detector row scanner

Other: ASSIGN Score
ASSIGN Cardiovascular Risk Score
Sham Comparator: Assign Score only Other: ASSIGN Score
ASSIGN Cardiovascular Risk Score
Outcome Measures
Primary Outcome Measures :
  1. Coronary heart disease death or non-fatal myocardial infarction [ Time Frame: 5 years ]
    The primary research objective of the trial is to determine whether, in individuals with risk for cardiovascular disease, coronary heart disease screening with CTCA is associated with a reduction in the rate of coronary heart disease death or non-fatal myocardial infarction when compared to a probabilistic cardiovascular risk score approach.


Secondary Outcome Measures :
  1. Death [ Time Frame: 5 Years ]
    Number of all-cause, cardiovascular, coronary heart disease and non-cardiovascular deaths

  2. Cardiovascular Events [ Time Frame: 5 Years ]
    Number of participants who have fatal and non-fatal myocardial infarction or stroke

  3. Cardiovascular Procedures [ Time Frame: 5 Years ]
    Number of Invasive coronary angiography and coronary revascularisation procedures

  4. Quality of Life (EQ-5D-5L) [ Time Frame: 2 Years ]
    Quality of life measured using EQ-5D-5L instrument

  5. Prescription [ Time Frame: 5 Years ]
    Rates of prescription of preventative therapies (anti-platelet, statin and angiotensin-converting enzyme inhibitor therapies)

  6. Lifestyle Modification [ Time Frame: 2 Years ]
    Uptake of lifestyle modifications (smoking, exercise and diet) measured using self-reported questionnaire

  7. Health Economics [ Time Frame: 2 Years ]
    Health economic assessment of cost-effectiveness

  8. Cholesterol [ Time Frame: 5 Years ]
    Serum cholesterol concentration

  9. Disadvantages of CTCA- Radiation [ Time Frame: 5 Years ]
    Radiation dose (mGy-cm)

  10. Disadvantages of CTCA- incidental findings [ Time Frame: 5 Years ]
    Number of participants with incidental findings from CTCA


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA

  • ≥40 and ≤70 years of age
  • Resident in Scotland and have a Community Health Index (CHI) number

  • One or more of the following risk factors:

    • Current or recent (within 12 months) smoker
    • Clinical diagnosis of hypertension
    • Known hypercholesterolaemia (total cholesterol >6.0 mmol/L or receiving statin therapy)
    • Diabetes mellitus
    • Rheumatoid arthritis
    • Systemic lupus erythematosus (SLE)
    • Family history of premature cardiovascular disease (first degree relative with atherosclerotic cardiovascular disease below 60 years)
    • Chronic kidney disease stage 3 (estimate glomerular filtration rate 30-59 mL/min/1.73 m2).

EXCLUSION CRITERIA

  • Inability to undergo CTCA
  • Known coronary heart disease or other major atherosclerotic cardiovascular disease
  • Prior invasive or non-invasive coronary angiography within the last 5 years
  • Chronic kidney disease stage ≥4 (estimate glomerular filtration rate <30 mL/min/1.73 m2)
  • Known homozygous familial hypercholesterolaemia or other serious inherited disorders of lipid metabolism requiring statin therapy
  • Intolerance of all statins
  • Statin therapy for >2 years.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: David E Newby 01312426515 d.e.newby@ed.ac.uk
Contact: Trial Manager 0131 651 9901 scot.heart2@ed.ac.uk

Sponsors and Collaborators
University of Edinburgh
British Heart Foundation
NHS Lothian
Investigators
Layout table for investigator information
Principal Investigator: David E Newby University of Edinburgh
Tracking Information
First Submitted Date  ICMJE April 16, 2019
First Posted Date  ICMJE April 18, 2019
Last Update Posted Date September 25, 2019
Estimated Study Start Date  ICMJE January 1, 2020
Estimated Primary Completion Date October 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2019) 		Coronary heart disease death or non-fatal myocardial infarction [ Time Frame: 5 years ]
The primary research objective of the trial is to determine whether, in individuals with risk for cardiovascular disease, coronary heart disease screening with CTCA is associated with a reduction in the rate of coronary heart disease death or non-fatal myocardial infarction when compared to a probabilistic cardiovascular risk score approach.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2019)
  • Death [ Time Frame: 5 Years ]
    Number of all-cause, cardiovascular, coronary heart disease and non-cardiovascular deaths
  • Cardiovascular Events [ Time Frame: 5 Years ]
    Number of participants who have fatal and non-fatal myocardial infarction or stroke
  • Cardiovascular Procedures [ Time Frame: 5 Years ]
    Number of Invasive coronary angiography and coronary revascularisation procedures
  • Quality of Life (EQ-5D-5L) [ Time Frame: 2 Years ]
    Quality of life measured using EQ-5D-5L instrument
  • Prescription [ Time Frame: 5 Years ]
    Rates of prescription of preventative therapies (anti-platelet, statin and angiotensin-converting enzyme inhibitor therapies)
  • Lifestyle Modification [ Time Frame: 2 Years ]
    Uptake of lifestyle modifications (smoking, exercise and diet) measured using self-reported questionnaire
  • Health Economics [ Time Frame: 2 Years ]
    Health economic assessment of cost-effectiveness
  • Cholesterol [ Time Frame: 5 Years ]
    Serum cholesterol concentration
  • Disadvantages of CTCA- Radiation [ Time Frame: 5 Years ]
    Radiation dose (mGy-cm)
  • Disadvantages of CTCA- incidental findings [ Time Frame: 5 Years ]
    Number of participants with incidental findings from CTCA
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Computed Tomography Coronary Angiography for the Prevention of Myocardial Infarction (The SCOT-HEART 2 Trial)
Official Title  ICMJE Computed Tomography Coronary Angiography for the Prevention of Myocardial Infarction (The SCOT-HEART 2 Trial)
Brief Summary It is hypothesised that, in individuals being considered for cardiovascular preventative therapy, computed tomography coronary angiography guided management will reduce the future risk of coronary heart disease death or non-fatal myocardial infarction compared to management guided by the current standard of care, a cardiovascular risk score.
Detailed Description Prevention of cardiovascular disease is currently guided by probabilistic risk scores that both over and under treat individuals, commit most middle-aged people to pharmacotherapy, and have little evidence base. It has been demonstrated that use of computed tomography coronary angiography (CTCA) is associated with changes in the diagnosis and treatment of patients presenting with stable chest pain, and that this leads to a marked reduction in the future risk of myocardial infarction. Importantly, the proportionate reduction in coronary events was most marked in those with non-anginal chest pain irrespective of their cardiovascular risk score which again demonstrated poor discrimination. The research team propose a randomised controlled trial of at least 6,000 middle-aged individuals at risk of cardiovascular disease that will compare these two strategies of targeting preventative therapies: a probabilistic cardiovascular risk score, and screening with CTCA. This trial will determine if CTCA guided management will be associated with better targeted intervention, prevent over medicating the general population, and result in fewer future coronary heart disease events than the current standard of care using a cardiovascular risk score.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Cardiovascular Diseases
Intervention  ICMJE
  • Diagnostic Test: Computed tomography coronary angiography
    CTCA >64 detector row scanner
  • Other: ASSIGN Score
    ASSIGN Cardiovascular Risk Score
Study Arms  ICMJE
  • Active Comparator: Computed tomography coronary angiography
    Interventions:
    • Diagnostic Test: Computed tomography coronary angiography
    • Other: ASSIGN Score
  • Sham Comparator: Assign Score only
    Intervention: Other: ASSIGN Score
Publications * Not Provided

*   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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 17, 2019) 		6000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 1, 2027
Estimated Primary Completion Date October 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

INCLUSION CRITERIA

  • ≥40 and ≤70 years of age
  • Resident in Scotland and have a Community Health Index (CHI) number

  • One or more of the following risk factors:

    • Current or recent (within 12 months) smoker
    • Clinical diagnosis of hypertension
    • Known hypercholesterolaemia (total cholesterol >6.0 mmol/L or receiving statin therapy)
    • Diabetes mellitus
    • Rheumatoid arthritis
    • Systemic lupus erythematosus (SLE)
    • Family history of premature cardiovascular disease (first degree relative with atherosclerotic cardiovascular disease below 60 years)
    • Chronic kidney disease stage 3 (estimate glomerular filtration rate 30-59 mL/min/1.73 m2).

EXCLUSION CRITERIA

  • Inability to undergo CTCA
  • Known coronary heart disease or other major atherosclerotic cardiovascular disease
  • Prior invasive or non-invasive coronary angiography within the last 5 years
  • Chronic kidney disease stage ≥4 (estimate glomerular filtration rate <30 mL/min/1.73 m2)
  • Known homozygous familial hypercholesterolaemia or other serious inherited disorders of lipid metabolism requiring statin therapy
  • Intolerance of all statins
  • Statin therapy for >2 years.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: David E Newby 01312426515 d.e.newby@ed.ac.uk
Contact: Trial Manager 0131 651 9901 scot.heart2@ed.ac.uk
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03920176
Other Study ID Numbers  ICMJE IRAS ID: 261185
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: The intention is to share anonymised data with external collaborators and scientists. The data will be available one year after the primary paper has been published (anticipated to be in 2027) .
Supporting Materials: Study Protocol
Supporting Materials: Clinical Study Report (CSR)
Time Frame: After 2027.
Access Criteria: Requests can be made by email from 2027.
Responsible Party University of Edinburgh
Study Sponsor  ICMJE University of Edinburgh
Collaborators  ICMJE
  • British Heart Foundation
  • NHS Lothian
Investigators  ICMJE
Principal Investigator: David E Newby University of Edinburgh
PRS Account University of Edinburgh
Verification Date September 2019

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

治疗医院

新药特效药

前沿医讯