Troponin Elevation in Acute Ischemic Stroke (TRELAS)

• Sponsor: Charite University, Berlin, Germany (Other)
• Overall Status: Completed
• CT.gov ID: NCT01263964
• Collaborator: (none)
• Enrollment: 58
• Locations: 2
• Duration (Months): 36
• Patients Per Site: 29
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Procedure: coronary angiogram

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 Design

• Study Type: Observational
• Actual Enrollment: 58 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Troponin Elevation in Acute Ischemic Stroke (TRELAS) - a Prospective Study on the Frequency and Correlation to Coronary Artery Disease and to Stroke Localisation
• Study Start Date: Feb 1, 2011
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Feb 1, 2014

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. culprit lesion on coronary angiogram [24 months]

Secondary Outcome Measures

1. transient apical ballooning on levocardiogram [24 months]

2. stroke localization [24 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Charite Campus Benjamin Franklin	Berlin		Germany	12203
2	Charite, Campus Benjamin Franklin	Berlin		Germany	12203

Sponsors and Collaborators

• Charite University, Berlin, Germany

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Christian Nolte, PD Dr.med., Charite University, Berlin, Germany
• ClinicalTrials.gov Identifier: NCT01263964
• Other Study ID Numbers: EA4/118/10; 01 EO 0801
• First Posted: Dec 21, 2010
• Last Update Posted: Jul 21, 2014
• Last Verified: Jul 1, 2014

• Keywords provided by Christian Nolte, PD Dr.med., Charite University, Berlin, Germany: ischemic stroke; troponin elevation; transient apical ballooning; acute coronary syndrome; troponin elevation,; culprit lesion on coronary angiogram,; troponin elevation and stroke localisation (temporal lobe?)
• Additional relevant MeSH terms: Stroke; Ischemic Stroke

Study Results

No Results Posted as of Jul 21, 2014