Troponin Elevation in Acute Ischemic Stroke (TRELAS) (TRELAS)

July 18, 2014 updated by: Christian Nolte, Charite University, Berlin, Germany

Troponin Elevation in Acute Ischemic Stroke (TRELAS) - a Prospective Study on the Frequency and Correlation to Coronary Artery Disease and to Stroke Localisation

The primary objective of the prospective observational trial TRELAS (TRoponin ELevation in Acute ischemic Stroke) is to elucidate the underlying pathomechanism of cTnT elevation in acute ischemic stroke. Consecutive patients with acute ischemic stroke admitted to the Department of Neurology Campus Benjamin Franklin of the university hospital Charité will be screened for cTnT elevations suggestive of myocardial infarction (>0,05 µg/l). Patients with increased troponin will undergo diagnostic coronary angiography within 72 hours. Diagnostic findings of coronary angiographies taken out in age- and gender-matched patients presenting with NSTE-ACS (Non-ST-Elevation Acute Coronary Syndrome) to the Division of Cardiology will serve as a control. The primary endpoint of the study will be the occurrence of culprit lesions indicating focal cardiac damage on the basis of an acute CAD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary objective of the prospective observational trial TRELAS (TRoponin ELevation in Acute ischemic Stroke) is to elucidate the underlying pathomechanism of cTnT elevation in acute ischemic stroke in order to give guidance for clinical practise. All consecutive patients with acute MRI- or CT-confirmed ischemic stroke admitting within 72 hours after symptom onset to the Department of Neurology Campus Benjamin Franklin of the university hospital of the Charité will be screened for cTnT elevations suggestive of myocardial infarction (>0,05 µg/l) on admission and day 2. Patients with increased troponin will undergo diagnostic coronary angiography within 72 hours. Diagnostic findings of coronary angiographies taken out in age- and gender-matched patients presenting with NSTE-ACS (Non-ST-Elevation Acute Coronary Syndrome) to the Division of Cardiology will serve as a control. The primary endpoint of the study will be the occurrence of angiographic culprit lesions indicating focal cardiac damage on the basis of an acute CAD. Secondary endpoints will be the localisation of stroke in the cerebral imaging and ventriculographic findings of wall motion abnormalities suggestive of neurally mediated global cardiac dysfunction.

Study Type

Observational

Enrollment (Actual)

58

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 12203
        • Charite Campus Benjamin Franklin
      • Berlin, Germany, 12203
        • Charite, Campus Benjamin Franklin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients admitted because acute ischemic stroke and additional troponin-elevation(cases) or non-stemi (controlls)

Description

Inclusion Criteria:

  1. Acute ischemic stroke, confirmed by cerebral MRI or CT, respectively
  2. Inclusion within ≤ 72 hours after symptom onset
  3. hsTroponin T >0,05 µg/l

Exclusion Criteria:

  1. Renal insufficiency (creatinine ≥1,2 mg/dl)
  2. Limited life expectancy or mRS ≥ 4 prior to stroke event leading to hospital admission
  3. Contraindications for the coronary angiography
  4. Age < 18 years
  5. Pregnancy
  6. Patient unwilling or unable to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
stroke, troponin elevation
Patients with stroke (proven by cerebral imaging) and troponin elevation undergoing coronary angiogram
Procedure: coronary angiogram
coronary angiogram
non-stemi (controll group)
Patients with troponin elevation suggesting non-stemi undergoing coronary angiogram
Procedure: coronary angiogram
coronary angiogram

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
culprit lesion on coronary angiogram
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
transient apical ballooning on levocardiogram
Time Frame: 24 months
24 months
stroke localization
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

  • Study Director: Matthias Endres, Professor, Charite Universitätsmedizin-Berlin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

December 20, 2010

First Submitted That Met QC Criteria

December 20, 2010

First Posted (Estimate)

December 21, 2010

Study Record Updates

Last Update Posted (Estimate)

July 21, 2014

Last Update Submitted That Met QC Criteria

July 18, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA4/118/10
  • 01 EO 0801 (Other Grant/Funding Number: German Ministry of Research and Education)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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