Troponin Elevation in Acute Ischemic Stroke (TRELAS)

Stroke Clinical Trial

— TRELAS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01263964
• Other study ID #: EA4/118/10
• Secondary ID: 01 EO 0801
• Status: Completed
• Phase: N/A
• First received: December 20, 2010
• Last updated: July 18, 2014
• Start date: February 2011
• Est. completion date: February 2014

Study information

• Verified date: July 2014
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: February 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Stroke

Intervention

Procedure:
• coronary angiogram
coronary angiogram

Locations

Country	Name	City	State
Germany	Charite Campus Benjamin Franklin	Berlin
Germany	Charite, Campus Benjamin Franklin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	culprit lesion on coronary angiogram		24 months	No
Secondary	transient apical ballooning on levocardiogram		24 months	No
Secondary	stroke localization		24 months	No