An observational study in Stroke, sponsored by University Hospital Bispebjerg and Frederiksberg. Completed at 1 site in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-31.
Sponsored by University Hospital Bispebjerg and Frederiksberg · Observational
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.
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 sex matches controls and patients with atherosclerotic stroke using cardiac MRI.
Background:
Despite standard work up for the etiology of ischemic stroke, about 30% of the cases remain unexplained. It is increasingly accepted that these unexplained cases arise from disease outside of the brain. Paroxysmal AF (Atrial fibrillation) may often be suspected as the source but fewer than one third of patients with stroke of undetermined source manifest AF in any form even after 3 years of continuous heart rhythm monitoring. Emerging evidence suggest that atrial functional and structural abnormalities may convey a comparable risk of stroke in which AF is only one of several features. These abnormalities have been termed "atrial cardiomyopathy" and may be an efficient and practical approach to identify patients at high risk of AF and ischemic stroke.
Methods and materials:
Cross sectional and prospective cohort study with 3 different groups: 50 patients with stroke of undetected mechanism, 50 patients with atherosclerotic stroke (large or small vessel disease) admitted to the University Hospital of Bispebjerg and Frederiksberg and 50 sex and age matched controls with no history of stroke or AF from the Copenhagen City Heart Study (ØBUS) will be included during a 2 year-period. The study will measure atrial structural abnormalities using cardiac magnetic resonance imaging (MRI) and atrial functional abnormalities by cardiac MRI and echocardiography. A 1 year follow up will examine the incidence of silent brain infarction with MRI and incidence of stroke, atrial fibrillation, acute myocardial infarction and cardiovascular death. Secondary endpoints are to examine the association of functional and structural changes found by MRI with echocardiography, rhythm abnormalities and biomarkers with the purpose of finding clinical easily applicable methods to diagnose atrial cardiomyopathy.
Expected outcome and perspectives:
The investigators hypothesize that patients with stroke of likely cardio-embolic origin have significantly more atrial fibrotic degeneration and reduced atrial emptying function than patients with atherosclerotic stroke and the control subjects. The investigators expect a higher incidence of silent brain infarction in the group with stroke of likely cardio-embolic origin. With atrial cardiomyopathy investigated thoroughly in patients with stroke of likely cardio-embolic origin the future work-up and treatment strategies could be more efficient and may thus improve the prognosis in terms of mortality and disability for a considerable number of patients.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 150 is close to the median of 160 across 1,692 observational studies indexed under Stroke.
Browse Stroke studies →University Hospital Bispebjerg and Frederiksberg is the lead sponsor of 68 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients are selected amongst individuals admitted with acute stroke to Bispebjerg University Hospital. Healthy controls will be invited from the the Copenhagen City Heart Study (ØBUS).
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.
Informed consent
Inclusion Criteria (Controls)
Exclusion Criteria (Patients):
Exclusion Criteria (Controls):
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 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 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.
Age and sex matched healthy controls with no history of stroke or AF.
Extent of the fibrosis in the Left Atrium (LA)
Measured with gadolinium enhanced cardiac MRI
Time frame: Within 12 weeks from index event
Left Atrial Emptying Function (LAEF)
Measured with gadolinium enhanced cardiac MRI
Time frame: Within 12 weeks from index event
Observational study: Incidence of silent brain infarctions
Incidence of silent brain infarctions assessed by follow-up MR-cerebrum (Only in patients)
Time frame: Between 1-2 years from index event
Left atrial volume
Assessed by cardiac MRI
Time frame: Within 12 weeks from index event
Left atrial appendage morphology
Assessed by cardiac MRI
Time frame: Within 8 weeks from index event
Left atrium volume
2D and 3D left atrial volume assessed by transthoracic echocardiography
Time frame: Within 12 weeks from index event
Left atrium ejection fraction (LAEF)
Assessed by transthoracic echocardiography
Time frame: Within 12 weeks from index event
Speckle tracking of LA
Assessed by transthoracic echocardiography
Time frame: Within 12 weeks from index event
Atrial rhythm abnormalities: Number of premature atrial contractions (PAC) per hour. Number and length of runs of PAC
Assessed by 48-hours Holter monitoring
Time frame: Within 4 weeks from index event
Heart rate variability (HRV)
Time domain variables (meanNN, SDNN, SDANN, SDNNidx, RMSSD, pNN50)
Time frame: Within 4 weeks from index event
Thrombophilia biomarkers
Assessment of hypercoagulability
Time frame: Within 12 weeks from index event
Cardiac specific biomarkers
Atrial Natriuretic Peptide, pro NT-Brain Natriuretic Peptide, High Sensitive Troponins.
Time frame: Within 12 weeks from index event
Inflammatory biomarkers
High Sensitive CRP, Interleukins: IL1, IL1b, IL6, IL18
Time frame: Within 12 weeks from index event
Fibrosis related markers
Collagen type I and III
Time frame: Within 12 weeks from index event
Observational study: Assessing incidence of stroke, acute myocardial infarction, atrial fibrillation and cardiovascular-death
Follow up in patient records
Time frame: 1 year from last included patient
Plan to share: Undecided — De-identified data will be made available to other research groups upon reasonable request.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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University Hospital Bispebjerg and Frederiksberg