Troponin Elevation in Acute Ischemic Stroke (TRELAS)

Completed

• Conditions: Stroke
• Interventions: Procedure: coronary angiogram

• Registration Number: NCT01263964
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

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

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 Timeline

• Study First Submitted: 2010-12-20
• Study First Submitted QC: 2010-12-20
• Study First Posted: 2010-12-21
• Study Start: 2011-02
• Primary Completion: 2013-12
• Study Completion: 2014-02
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-18
• Last Update Posted: 2014-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
culprit lesion on coronary angiogram	24 months

Secondary Outcome Measures

Name	Time	Method
stroke localization	24 months
transient apical ballooning on levocardiogram	24 months

Trial Locations

Locations (2)

Charite, Campus Benjamin Franklin; 🇩🇪 Berlin, Germany

Charite Campus Benjamin Franklin; 🇩🇪 Berlin, Germany