StrokeCaMriSSNCT01917955
Cardiac MRI in Ischemic Stroke Study
An observational study of Stroke, run by Charite University, Berlin, Germany at 2 sites in Germany.
Trial summary
The purpose of this prospective single-center trial is to compare the safety and diagnostic value of contrast medium-enhanced cardiac magnetic resonance imaging and transesophageal echocardiography in patients with acute ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- How many people
- 103 participants
- Where
- 2 sitesGermany
- Study dates
- Jan 2012to Nov 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: Overall, 103 patients with acute ischemic stroke detected by brain magnetic resonance imaging will be enrolled.
Who may be able to join
- Patients with acute ischemic stroke detected by brain magnetic resonance imaging.
Who cannot join
- Known atrial fibrillation or cardiac source of embolism
- Severe aphasia
- Acute infection or chronic inflammation
- Severe arteriosclerosis or stenosis of brain-supplying arteries
- Contraindications for magnetic resonance imaging or transesophageal echocardiography.
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Charité, Universitätsmedizin Berlin, Campus Benjamin Franklin
Berlin, 12203
Elisabeth Hospital
Essen
About this study
The purpose of this prospective single-center trial is to compare the safety and diagnostic value of contrast medium-enhanced cardiac magnetic resonance imaging and transesophageal echocardiography in patients with acute ischemic stroke.
Read the detailed description
Primary safety objective: Contrast medium-enhanced cardiac magnetic resonance imaging is safe in patients with acute ischemic stroke. Primary outcome: The diagnostic value of contrast medium-enhanced cardiac magnetic resonance imaging is comparable to transesophageal echocardiography in patients with acute ischemic stroke.
- Conditions
- Stroke
- Keywords
- MRI
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of contrast medium-enhanced cardiac magnetic resonance imaging to detect echocardiography-proven cardiac sources of embolism in patients with acute ischemic stroke.
Measured: < 1 week after ischemic stroke
Secondary outcomes (1)
Rate of unrecognised myocardial infarction detected by late gadolinium-enhanced cardiac MRI in patients with acute ischemic stroke.
Measured: < 1 week after ischemic stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2013 (estimated)
- Study startJan 2012
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Stroke Research Berlin, Cardiology and Angiology, Elisabeth Hospital, Essen, Germany
- Responsible party
- Principal investigator, Karl Georg Haeusler, Charite University, Berlin, Germany
- Investigators
- Prof. Matthias Endres, MD, Study chair, Center for Stroke Research BerlinKarl Georg Haeusler, MD, Principal investigator, Center for Stroke Research Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01917955
- Sponsor's protocol ID
- CaMriSS_CSB
- Other IDs
- EA4/073/10
- Acronym
- CaMriSS
- Status last verified
- Nov 2016
- First submitted
- 7 Aug 2012
- Last updated
- 8 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Haeusler KG, Wollboldt C, Bentheim LZ, Herm J, Jager S, Kunze C, Eberle HC, Deluigi CC, Bruder O, Malsch C, Heuschmann PU, Endres M, Audebert HJ, Morguet AJ, Jensen C, Fiebach JB. Feasibility and Diagnostic Value of Cardiovascular Magnetic Resonance Imaging After Acute Ischemic Stroke of Undetermined Origin. Stroke. 2017 May;48(5):1241-1247. doi: 10.1161/STROKEAHA.116.016227. Epub 2017 Apr 14.
PubMed 28411261
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac MRI in Ischemic Stroke Study
- ClinicalTrials.gov ID
- NCT01917955
- Acronym / sponsor ID
- CaMriSS / CaMriSS_CSB
- Conditions
- Stroke
- Keywords
- MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Center for Stroke Research Berlin, Cardiology and Angiology, Elisabeth Hospital, Essen, Germany
- Study start
- Jan 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 7 Aug 2013 (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 purpose of this prospective single-center trial is to compare the safety and diagnostic value of contrast medium-enhanced cardiac magnetic resonance imaging and transesophageal echocardiography in patients with acute ischemic stroke.
Detailed description
Primary safety objective: Contrast medium-enhanced cardiac magnetic resonance imaging is safe in patients with acute ischemic stroke. Primary outcome: The diagnostic value of contrast medium-enhanced cardiac magnetic resonance imaging is comparable to transesophageal echocardiography in patients with acute ischemic stroke.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Overall, 103 patients with acute ischemic stroke detected by brain magnetic resonance imaging will be enrolled.
Key inclusion criteria (1 listed)
- Patients with acute ischemic stroke detected by brain magnetic resonance imaging.
Key exclusion criteria (5 listed)
- Known atrial fibrillation or cardiac source of embolism
- Severe aphasia
- Acute infection or chronic inflammation
- Severe arteriosclerosis or stenosis of brain-supplying arteries
- Contraindications for magnetic resonance imaging or transesophageal echocardiography.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity and specificity of contrast medium-enhanced cardiac magnetic resonance imaging to detect echocardiography-proven cardiac sources of embolism in patients with acute ischemic stroke.
Time frame: < 1 week after ischemic stroke
1 secondary outcome
Rate of unrecognised myocardial infarction detected by late gadolinium-enhanced cardiac MRI in patients with acute ischemic stroke.
Time frame: < 1 week after ischemic stroke
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 8 Nov 2016.
- Derived from this study: PubMed 28411261Haeusler KG, Wollboldt C, Bentheim LZ, Herm J, Jager S, Kunze C, Eberle HC, Deluigi CC, Bruder O, Malsch C, Heuschmann PU, Endres M, Audebert HJ, Morguet AJ, Jensen C, Fiebach JB. Feasibility and Diagnostic Value of Cardiovascular Magnetic Resonance Imaging After Acute Ischemic Stroke of Undetermined Origin. Stroke. 2017 May;48(5):1241-1247. doi: 10.1161/STROKEAHA.116.016227. Epub 2017 Apr 14.
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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.
Prof. Matthias Endres, MD study chair
Center for Stroke Research Berlin
Karl Georg Haeusler, MD principal investigator
Center for Stroke Research 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 1 inclusion and 5 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 8 Nov 2016. 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?
Sensitivity and specificity of contrast medium-enhanced cardiac magnetic resonance imaging to detect echocardiography-proven cardiac sources of embolism in patients with acute ischemic stroke. (time frame: < 1 week after ischemic stroke). 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 NCT01917955, which also lists 1 linked publication.
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 8 Nov 2016.