Troponin Elevation in Acute Ischemic Stroke (TRELAS)

NCT ID: NCT01263964

Last Updated: 2014-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

58 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2014-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Stroke

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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stroke, troponin elevation

Patients with stroke (proven by cerebral imaging) and troponin elevation undergoing coronary angiogram

coronary angiogram

Intervention Type PROCEDURE

coronary angiogram

non-stemi (controll group)

Patients with troponin elevation suggesting non-stemi undergoing coronary angiogram

coronary angiogram

Intervention Type PROCEDURE

coronary angiogram

Interventions

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coronary angiogram

coronary angiogram

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Christian Nolte

PD Dr.med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Matthias Endres, Professor

Role: STUDY_DIRECTOR

Charite Universitätsmedizin-Berlin

Locations

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Charite Campus Benjamin Franklin

Berlin, Germany, Germany

Site Status

Charite, Campus Benjamin Franklin

Berlin, State of Berlin, Germany

Site Status

Countries

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Germany

References

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Mochmann HC, Scheitz JF, Petzold GC, Haeusler KG, Audebert HJ, Laufs U, Schneider C, Landmesser U, Werner N, Endres M, Witzenbichler B, Nolte CH; TRELAS Study Group. Coronary Angiographic Findings in Acute Ischemic Stroke Patients With Elevated Cardiac Troponin: The Troponin Elevation in Acute Ischemic Stroke (TRELAS) Study. Circulation. 2016 Mar 29;133(13):1264-71. doi: 10.1161/CIRCULATIONAHA.115.018547. Epub 2016 Mar 1.

Reference Type DERIVED
PMID: 26933082 (View on PubMed)

Scheitz JF, Mochmann HC, Nolte CH, Haeusler KG, Audebert HJ, Heuschmann PU, Laufs U, Witzenbichler B, Schultheiss HP, Endres M. Troponin elevation in acute ischemic stroke (TRELAS)--protocol of a prospective observational trial. BMC Neurol. 2011 Aug 8;11:98. doi: 10.1186/1471-2377-11-98.

Reference Type DERIVED
PMID: 21824425 (View on PubMed)

Other Identifiers

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01 EO 0801

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

EA4/118/10

Identifier Type: -

Identifier Source: org_study_id

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