Status:
COMPLETED
Atrial Cardiomyopathy in Patients With Stroke of Undetected Mechanism
Lead Sponsor:
University Hospital Bispebjerg and Frederiksberg
Collaborating Sponsors:
Rigshospitalet, Denmark
Lundbeck Foundation
Conditions:
Stroke
Eligibility:
All Genders
18+ years
Brief Summary
The goal of this study is to evaluate left atrial structural and functional abnormalities in stroke of undetected mechanism and atherosclerotic stroke with cardiac MRI.
Detailed Description
Aims and objectives: The goal of this study is to evaluate left atrial structural and functional abnormalities in patients with stroke of likely cardio-embolic origin compared with healthy age and se...
Eligibility Criteria
Inclusion
- Inclusion Criteria (Patients):
- Stroke of likely cardioembolic cause or of undetected mechanism:
- Lesions in at least one territory on MRI \& absence of significant large vessel disease defined as stenosis of cerebral or pre-cerebral vessels \>50% in arteries supplying the ischemic area(s) \& absence of severe small vessel disease including micro-bleeds on MRI.
- Patients with central retinal artery occlusion documented by perimeter and absence of significant large vessel disease defined as stenosis of cerebral or pre-cerebral vessels \>50% \& absence of severe small vessel disease including micro-bleeds on MRI are included independent of acute MRI findings.
- Large or small vessel stroke (atherosclerotic stroke):
- Large vessel stroke: Acute lesions in one vascular territory on MRI, significant large vessel disease defined as stenosis of cerebral or pre-cerebral vessels \>50% leading to the infarcted territory \& absence of severe small vessel disease including micro-bleeds on MRI Small Vessel stroke: MRI documenting lacunar infarction, absence of significant large vessel disease defined as stenosis of cerebral or pre-cerebral vessels \>50% and presence of severe small vessel disease possibly including micro bleeds.
- Ischemic stroke within 30 days prior to inclusion
- Age \> 18 years
- Life expectancy of at least one year
- Informed consent
- Stenosis: % defined by Ultrasound
- Small vessel disease: defined according to STRIVE criteria
- Inclusion Criteria (Controls)
- 1\. Age and sex matched healthy controls. Matched with the group with stroke of likely cardioembolic stroke.
- Exclusion Criteria (Patients):
- Prior AF or AF \>30 sec on at least 6 hours of monitoring during hospitalization.
- Other major cardio-embolic risk sources assumed as cause of stroke (e.g. endocarditis, myocardial infarction within last 4 weeks, prosthetic cardiac valve)
- Contraindications to MRI (Including eGFR\<30 or other contraindications for the contrast agent used during Cardiac MRI)
- Assumed unable to participate in the study by investigator (including but not restricted to psychiatric condition, dementia)
- Exclusion Criteria (Controls):
- History of stroke or AF
- Contraindications to MRI (Including eGFR\<30 mL/min/1.73 m2 or other contraindications for the contrast agent used during Cardiac MRI)
- Assumed unable to participate in the study by the investigator (For the same reasons listed above)
Exclusion
Key Trial Info
Start Date :
March 8 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 31 2023
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03830983
Start Date
March 8 2019
End Date
January 31 2023
Last Update
March 31 2023
Active Locations (1)
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1
Bispebjerg Hospital
Copenhagen NV, Copenhagen, Denmark, 2400