StrokeTRELASNCT01263964
Troponin Elevation in Acute Ischemic Stroke (TRELAS)
An observational study of Stroke, run by Charite University, Berlin, Germany at 2 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- coronary angiogram
- Type of treatment
- Surgery or procedure
- How many people
- 58 participants
- Where
- 2 sitesGermany
- Study dates
- Feb 2011to Feb 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted because acute ischemic stroke and additional troponin-elevation(cases) or non-stemi (controlls)
Who may be able to join
- Acute ischemic stroke, confirmed by cerebral MRI or CT, respectively
- Inclusion within ≤ 72 hours after symptom onset
- hsTroponin T >0,05 µg/l
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Charite Campus Benjamin Franklin
Berlin, Germany, 12203
Charite, Campus Benjamin Franklin
Berlin, State of Berlin, 12203
About this study
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
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- coronary angiogram
- 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?)
- Medical subject headings
- Stroke, Ischemic Stroke, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coronary angiogramProcedure or surgery
coronary angiogram
| Study group | Role | What they receive |
|---|---|---|
| stroke, troponin elevation | Patients with stroke (proven by cerebral imaging) and troponin elevation undergoing coronary angiogram Receives: Procedure: coronary angiogram | |
| non-stemi (controll group) | Patients with troponin elevation suggesting non-stemi undergoing coronary angiogram Receives: Procedure: coronary angiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
culprit lesion on coronary angiogram
Measured: 24 months
Secondary outcomes (2)
transient apical ballooning on levocardiogram
Measured: 24 months
stroke localization
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2010 (estimated)
- Study startFeb 2011
- Primary completionDec 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Nolte, Charite University, Berlin, Germany
- Investigators
- Matthias Endres, Professor, Study director, Charite Universitätsmedizin-Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01263964
- Sponsor's protocol ID
- EA4/118/10
- Other IDs
- 01 EO 0801
- Acronym
- TRELAS
- Status last verified
- Jul 2014
- First submitted
- 20 Dec 2010
- Last updated
- 21 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26933082Scheitz 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.
PubMed 21824425
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01263964
- Acronym / sponsor ID
- TRELAS / EA4/118/10
- 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?)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 21 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stroke, troponin elevation | – | Procedure: coronary angiogramPatients with stroke (proven by cerebral imaging) and troponin elevation undergoing coronary angiogram |
| non-stemi (controll group) | – | Procedure: coronary angiogramPatients with troponin elevation suggesting non-stemi undergoing coronary angiogram |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted because acute ischemic stroke and additional troponin-elevation(cases) or non-stemi (controlls)
Key inclusion criteria (3 listed)
- Acute ischemic stroke, confirmed by cerebral MRI or CT, respectively
- Inclusion within ≤ 72 hours after symptom onset
- hsTroponin T >0,05 µg/l
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coronary angiogramcoronary angiogram | Procedure or surgery | non-stemi (controll group), stroke, troponin elevation |
Primary outcome
culprit lesion on coronary angiogram
Time frame: 24 months
2 secondary outcomes
transient apical ballooning on levocardiogram
Time frame: 24 months
stroke localization
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2014.
- Derived from this study: PubMed 26933082Mochmann 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.
- Derived from this study: PubMed 21824425Scheitz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Endres, Professor study director
Charite Universitätsmedizin-Berlin
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Charite University, Berlin, Germany at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
culprit lesion on coronary angiogram (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01263964, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2014.