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出境医 / 临床实验 / Troponin- I Elevation Predicts Outcome After Thrombolysis in Stroke Patients

Troponin- I Elevation Predicts Outcome After Thrombolysis in Stroke Patients

Study Description
Brief Summary:
Elevated level of serum troponin (T-I) has been regarded as a prognostic biomarker of poor outcome in acute ischemic stroke. However, its role in outcome in thrombolysed ischemic stroke patients remains uncertain. The aim of this study was to evaluate the role of T-I as a predictive biomarker of short-term outcome in thrombolysed ischemic stroke participants.

Condition or disease
Cerebrovascular Accident

Detailed Description:
Elevated level of serum troponin (T-I) has been regarded as a prognostic biomarker of poor outcome in acute ischemic stroke. However, its role in outcome in thrombolysed ischemic stroke patients remains uncertain. The aim of this study was to evaluate the role of T-I as a predictive biomarker of short-term outcome in thrombolysed ischemic stroke patients. Methods: This study included 72 acute ischemic stroke participants were treated with intravenous thrombolytic therapy. All participants were subjected to general and neurological evaluation including assessment of stroke severity using National Institute of Health Stroke Scale (NIHSS) at admission and investigations including measurement of serum level of T-I on admission. Outcome was assessed three months after stroke onset using NIHSS and modified Rankin scale (mRS).
Study Design
Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 81 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Troponin- I Elevation Predicts Outcome After Thrombolysis in Stroke Patients
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : January 31, 2019
Actual Study Completion Date : March 31, 2019
Arms and Interventions
Group/Cohort
group 1
participants with elevated serum troponin level (≥0.01μg/L)
group 2
those with normal serum troponin level (<0.01μg/L)
Outcome Measures
Primary Outcome Measures :
  1. good neurological Outcome after thrombolysis [ Time Frame: three months ]
    Neurological Outcome was assessed by National Institute of Health Stroke Scale (NIHSS) . good outcome (neurological improvement) was defined as 8 points improvement in NIHSS

  2. poor neurological Outcome after thrombolysis [ Time Frame: three months ]

    Neurological Outcome was assessed by the modified Rankin Scale (mRS). The modified Rankin Scale consists of 6 grades, from 0 to 5, with the best score 0 (corresponding to no symptoms) and the worst score 5 (corresponding to severe disability).

    Poor outcome was defined as death or disability (mRS scores ≥2).



Biospecimen Retention:   Samples Without DNA
Serum troponin I (T-I) was collected at hospital admission at the emergency department, before any treatment. Serum samples from patients were drawn using standard venipuncture techniques. Blood samples were left to clot for 4 hours at room temperature, then centrifuged to obtain the serum which was stored frozen at (-20C). Serum T-I levels were quantified in an enzyme-linked immune-sorbent assay technology (ELISA) following manufacturer's instructions (ALPCO, 26G Keewaydin Drive, Salem NH03079, USA). Upper reference limit for apparently healthy individuals is <0.01μg/l.

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Eighty one thrombolysed ischemic stroke patients were enrolled in this study. Participants who did not complete the study (9 Participants were lost during follow up) were eliminated. So the study included seventy two Participants (34 males and 38 females) who fulfilled the inclusion and exclusion criteria.
Criteria

Inclusion Criteria:

  • Participants were eligible for inclusion in the study if they had evidence suggesting acute ischemic stroke that lasted for ≤ 4.5 hours .
  • Those Participants were treated with intravenous thrombolytic therapy ((recombinant tissue plasminogen activator (rt-PA)).

Exclusion Criteria:

  • Those who had hemorrhagic stroke
  • participants presented with acute myocardial infarction, cerebrovascular stroke in the previous three months.
  • serious head trauma in the previous three months.
  • urinary tract, lung, or gastrointestinal hemorrhage within the three weeks.
  • serious trauma or major surgery within the previous two weeks.
  • lumbar or arterial puncture at a non-compressible site within one week.
  • those received heparin within 48 hours, resulting in an activated partial thromboplastin time greater than the upper limit of normal.
  • systolic pressure > 185 mmHg or diastolic pressure > 110 mmHg.
  • blood glucose <50 or > 400 mg/dL.
  • current use of anticoagulants with an International Normalized Ratio > 1.7 or prothrombin time>15 sec; platelet count < 100,000/mm3.
  • pregnancy; serious heart, lung, kidney or other organ dysfunction.
  • allergy to active ingredients of rt-PA; patients with > 4.5 hours from the last time known to be asymptomatic.
  • those in whom troponin was not measured at admission were excluded from the study
Contacts and Locations

No Contacts or Locations Provided

Tracking Information
First Submitted Date April 17, 2019
First Posted Date April 24, 2019
Last Update Posted Date April 24, 2019
Actual Study Start Date January 1, 2017
Actual Primary Completion Date January 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 19, 2019)
  • good neurological Outcome after thrombolysis [ Time Frame: three months ]
    Neurological Outcome was assessed by National Institute of Health Stroke Scale (NIHSS) . good outcome (neurological improvement) was defined as 8 points improvement in NIHSS
  • poor neurological Outcome after thrombolysis [ Time Frame: three months ]
    Neurological Outcome was assessed by the modified Rankin Scale (mRS). The modified Rankin Scale consists of 6 grades, from 0 to 5, with the best score 0 (corresponding to no symptoms) and the worst score 5 (corresponding to severe disability). Poor outcome was defined as death or disability (mRS scores ≥2).
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Troponin- I Elevation Predicts Outcome After Thrombolysis in Stroke Patients
Official Title Troponin- I Elevation Predicts Outcome After Thrombolysis in Stroke Patients
Brief Summary Elevated level of serum troponin (T-I) has been regarded as a prognostic biomarker of poor outcome in acute ischemic stroke. However, its role in outcome in thrombolysed ischemic stroke patients remains uncertain. The aim of this study was to evaluate the role of T-I as a predictive biomarker of short-term outcome in thrombolysed ischemic stroke participants.
Detailed Description Elevated level of serum troponin (T-I) has been regarded as a prognostic biomarker of poor outcome in acute ischemic stroke. However, its role in outcome in thrombolysed ischemic stroke patients remains uncertain. The aim of this study was to evaluate the role of T-I as a predictive biomarker of short-term outcome in thrombolysed ischemic stroke patients. Methods: This study included 72 acute ischemic stroke participants were treated with intravenous thrombolytic therapy. All participants were subjected to general and neurological evaluation including assessment of stroke severity using National Institute of Health Stroke Scale (NIHSS) at admission and investigations including measurement of serum level of T-I on admission. Outcome was assessed three months after stroke onset using NIHSS and modified Rankin scale (mRS).
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 3 Months
Biospecimen Retention:   Samples Without DNA
Description:
Serum troponin I (T-I) was collected at hospital admission at the emergency department, before any treatment. Serum samples from patients were drawn using standard venipuncture techniques. Blood samples were left to clot for 4 hours at room temperature, then centrifuged to obtain the serum which was stored frozen at (-20C). Serum T-I levels were quantified in an enzyme-linked immune-sorbent assay technology (ELISA) following manufacturer's instructions (ALPCO, 26G Keewaydin Drive, Salem NH03079, USA). Upper reference limit for apparently healthy individuals is <0.01μg/l.
Sampling Method Probability Sample
Study Population Eighty one thrombolysed ischemic stroke patients were enrolled in this study. Participants who did not complete the study (9 Participants were lost during follow up) were eliminated. So the study included seventy two Participants (34 males and 38 females) who fulfilled the inclusion and exclusion criteria.
Condition Cerebrovascular Accident
Intervention Not Provided
Study Groups/Cohorts
  • group 1
    participants with elevated serum troponin level (≥0.01μg/L)
  • group 2
    those with normal serum troponin level (<0.01μg/L)
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 Completed
Actual Enrollment
 (submitted: April 19, 2019) 		81
Original Actual Enrollment Same as current
Actual Study Completion Date March 31, 2019
Actual Primary Completion Date January 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Participants were eligible for inclusion in the study if they had evidence suggesting acute ischemic stroke that lasted for ≤ 4.5 hours .
  • Those Participants were treated with intravenous thrombolytic therapy ((recombinant tissue plasminogen activator (rt-PA)).

Exclusion Criteria:

  • Those who had hemorrhagic stroke
  • participants presented with acute myocardial infarction, cerebrovascular stroke in the previous three months.
  • serious head trauma in the previous three months.
  • urinary tract, lung, or gastrointestinal hemorrhage within the three weeks.
  • serious trauma or major surgery within the previous two weeks.
  • lumbar or arterial puncture at a non-compressible site within one week.
  • those received heparin within 48 hours, resulting in an activated partial thromboplastin time greater than the upper limit of normal.
  • systolic pressure > 185 mmHg or diastolic pressure > 110 mmHg.
  • blood glucose <50 or > 400 mg/dL.
  • current use of anticoagulants with an International Normalized Ratio > 1.7 or prothrombin time>15 sec; platelet count < 100,000/mm3.
  • pregnancy; serious heart, lung, kidney or other organ dysfunction.
  • allergy to active ingredients of rt-PA; patients with > 4.5 hours from the last time known to be asymptomatic.
  • those in whom troponin was not measured at admission were excluded from the study
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03925298
Other Study ID Numbers ZU-IRB#5335\ 24-6-2018
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
Plan to Share IPD: Yes
Plan Description: after publishing the manuscript in the Egyptian journal of neurology. psychiatry and neurosurgery
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: after publishing the manuscript in the Egyptian journal of neurology. psychiatry and neurosurgery
Access Criteria: after publishing the manuscript in the Egyptian journal of neurology. psychiatry and neurosurgery
URL: http://ejnpn.springeropen.com
Responsible Party rania sanad, Zagazig University
Study Sponsor Zagazig University
Collaborators Not Provided
Investigators Not Provided
PRS Account Zagazig University
Verification Date April 2019

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