Troponin Elevation in Acute Ischemic Stroke (TRELAS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christian Nolte, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01263964
First received: December 20, 2010
Last updated: July 18, 2014
Last verified: July 2014

December 20, 2010
July 18, 2014
February 2011
December 2013   (final data collection date for primary outcome measure)
culprit lesion on coronary angiogram [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01263964 on ClinicalTrials.gov Archive Site
  • transient apical ballooning on levocardiogram [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • stroke localization [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Troponin Elevation in Acute Ischemic Stroke (TRELAS)
Troponin Elevation in Acute Ischemic Stroke (TRELAS) - a Prospective Study on the Frequency and Correlation to Coronary Artery Disease and to Stroke Localisation

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Biomarkers indicating myocardial or neuronal damage

Non-Probability Sample

Patients admitted because acute ischemic stroke and additional troponin-elevation(cases) or non-stemi (controlls)

Stroke
Procedure: coronary angiogram
coronary angiogram
  • stroke, troponin elevation
    Patients with stroke (proven by cerebral imaging) and troponin elevation undergoing coronary angiogram
    Intervention: Procedure: coronary angiogram
  • non-stemi (controll group)
    Patients with troponin elevation suggesting non-stemi undergoing coronary angiogram
    Intervention: Procedure: coronary angiogram
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
February 2014
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01263964
EA4/118/10, 01 EO 0801
No
Christian Nolte, Charite University, Berlin, Germany
Charite University, Berlin, Germany
Not Provided
Study Director: Matthias Endres, Professor Charite Universitätsmedizin-Berlin
Charite University, Berlin, Germany
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP