NCT01263964

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2011

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 21, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

July 21, 2014

Status Verified

July 1, 2014

Enrollment Period

2.8 years

First QC Date

December 20, 2010

Last Update Submit

July 18, 2014

Conditions

Stroke

Keywords

ischemic stroketroponin elevationtransient apical ballooningacute coronary syndrometroponin elevation,culprit lesion on coronary angiogram,troponin elevation and stroke localisation (temporal lobe?)

Outcome Measures

Primary Outcomes (1)

  • culprit lesion on coronary angiogram

    24 months

Secondary Outcomes (2)

  • transient apical ballooning on levocardiogram

    24 months

  • stroke localization

    24 months

Study Arms (2)

stroke, troponin elevation

Patients with stroke (proven by cerebral imaging) and troponin elevation undergoing coronary angiogram

Procedure: coronary angiogram

non-stemi (controll group)

Patients with troponin elevation suggesting non-stemi undergoing coronary angiogram

Procedure: coronary angiogram

Interventions

coronary angiogramPROCEDURE

coronary angiogram

non-stemi (controll group)stroke, troponin elevation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Acute ischemic stroke, confirmed by cerebral MRI or CT, respectively
  • hsTroponin T \>0,05 µg/l

You may not qualify if:

  • Renal insufficiency (creatinine ≥1,2 mg/dl)
  • Limited life expectancy or mRS ≥ 4 prior to stroke event leading to hospital admission
  • Contraindications for the coronary angiography
  • Age \< 18 years
  • Pregnancy
  • Patient unwilling or unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Charite Campus Benjamin Franklin

Berlin, Germany, 12203, Germany

Location

Charite, Campus Benjamin Franklin

Berlin, State of Berlin, 12203, Germany

Location

Related Publications (2)

  • 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.

    PMID: 26933082DERIVED

  • 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.

    PMID: 21824425DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biomarkers indicating myocardial or neuronal damage

MeSH Terms

Conditions

StrokeIschemic StrokeAcute Coronary Syndrome

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesMyocardial IschemiaHeart Diseases

Study Officials

  • Matthias Endres, Professor

    Charite Universitätsmedizin-Berlin

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr.med.

Study Record Dates

First Submitted

December 20, 2010

First Posted

December 21, 2010

Study Start

February 1, 2011

Primary Completion

December 1, 2013

Study Completion

February 1, 2014

Last Updated

July 21, 2014

Record last verified: 2014-07

Locations

DE(2)