Atrial Cardiomyopathy in Patients With Stroke of Undetected Mechanism

NCT03830983 | Completed DMC

• 1 other identifier: 18055313
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Cardioembolic stroke; Cardiac MRI; Heart disease; Vascular disease

Outcome Measures

Primary Outcomes (2)

• Extent of the fibrosis in the Left Atrium (LA)

  Measured with gadolinium enhanced cardiac MRI

  Within 12 weeks from index event

• Left Atrial Emptying Function (LAEF)

  Measured with gadolinium enhanced cardiac MRI

  Within 12 weeks from index event

Secondary Outcomes (12)

• Observational study: Incidence of silent brain infarctions

  Between 1-2 years from index event

• Left atrial volume

  Within 12 weeks from index event

• Left atrial appendage morphology

  Within 8 weeks from index event

• Left atrium volume

  Within 12 weeks from index event

• Left atrium ejection fraction (LAEF)

  Within 12 weeks from index event

Other Outcomes (1)

• Observational study: Assessing incidence of stroke, acute myocardial infarction, atrial fibrillation and cardiovascular-death

  1 year from last included patient

Study Arms (3)

Stroke of likely cardioembolic cause or 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 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.

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.

Controls

Age and sex matched healthy controls with no history of stroke or AF.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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).

You may qualify if:

• 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.
• Age \> 18 years
• Life expectancy of at least one year
• Informed consent
• Stenosis: % defined by Ultrasound
• Small vessel disease: defined according to STRIVE criteria
• \. Age and sex matched healthy controls. Matched with the group with stroke of likely cardioembolic stroke.

You may not qualify if:

• 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)
• 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)

Sponsors & Collaborators

• University Hospital Bispebjerg and Frederiksberg: lead
• Rigshospitalet, Denmark: collaborator
• Lundbeck Foundation: collaborator

Study Sites (1)

Bispebjerg Hospital

Copenhagen NV, Copenhagen, 2400, Denmark

Location

Related Publications (1)

• Larsen BS, Aplin M, Host N, Dominguez H, Christensen H, Christensen LM, Havsteen I, Prescott E, Jensen GB, Vejlstrup N, Bertelsen L, Sajadieh A. Atrial cardiomyopathy in patients with ischaemic stroke: a cross-sectional and prospective cohort study-the COAST study. BMJ Open. 2022 May 11;12(5):e061018. doi: 10.1136/bmjopen-2022-061018.

  PMID: 35545392 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

For use in future studies of biomarkers and genes we will collect 2 samples of plasma and 1 sample of full blood. Only patient who give informed consent will have these samples collected.

MeSH Terms

Conditions

Stroke; Embolic Stroke; Heart Diseases; Vascular Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cardiovascular Diseases; Ischemic Stroke

Study Officials

• Ahmad Sajadieh, MD, DMSc

  University Hospital Bispebjerg and Frederiksberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, DMSc

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: February 5, 2019
• Study Start: March 8, 2019
• Primary Completion: September 6, 2021
• Study Completion: January 31, 2023
• Last Updated: March 31, 2023

Record last verified: 2023-03

Locations

DK (1)