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
  Purpose

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 Intervention
Stroke
Procedure: coronary angiogram

Study Type: Observational
Study Design: 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

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • culprit lesion on coronary angiogram [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA

Biomarkers indicating myocardial or neuronal damage


Enrollment: 58
Study Start Date: February 2011
Study Completion Date: February 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01263964

Locations
Germany
Charite Campus Benjamin Franklin
Berlin, Germany, 12203
Charite, Campus Benjamin Franklin
Berlin, Germany, 12203
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Study Director: Matthias Endres, Professor Charite Universitätsmedizin-Berlin
  More Information

No publications provided by Charite University, Berlin, Germany

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christian Nolte, PD Dr.med., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01263964     History of Changes
Other Study ID Numbers: EA4/118/10, 01 EO 0801
Study First Received: December 20, 2010
Last Updated: July 18, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by 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:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014