Clinical trial NCT01263964: Troponin Elevation in Acute Ischemic Stroke (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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: ischemic stroke
troponin elevation
transient apical ballooning
acute coronary syndrome
troponin elevation,
culprit lesion on coronary angiogram,
troponin elevation and stroke localisation (temporal lobe?)
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2010-12-21
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted because acute ischemic stroke and additional troponin-elevation(cases) or non-stemi (controlls)

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.

Eligibility criteria: 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

Primary outcomes:
measure: culprit lesion on coronary angiogram
timeFrame: 24 months
Secondary outcomes:
measure: transient apical ballooning on levocardiogram
timeFrame: 24 months
measure: stroke localization
timeFrame: 24 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite Campus Benjamin Franklin
city: Berlin
country: Germany
facility: Charite, Campus Benjamin Franklin
Study officials:
affiliation: Charite Universitätsmedizin-Berlin
name: Matthias Endres, Professor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.