AFLETES-MRI: A Cardiac and Cerebral Magnetic Resonance Imaging Study in Athletes With Atrial Fibrillation (AFLETES-MRI)

May 20, 2024 updated by: University of Leicester

Atrial Fibrillation and the Risk of Stroke in Veteran athLETES: a Pilot Cardiac and Cerebral Magnetic Resonance Imaging Study - AFLETES-MRI

Participation in exercise improves cardiovascular health. However, long-term endurance exercise may increase the risk of an irregular heart rhythm called atrial fibrillation (AF).

In AF, blood flow is altered, increasing the risk of clot formation in the heart which may enter the circulation and cause a stroke. The risk of stroke can be reduced with the use of blood thinning medication. Athletes with atrial fibrillation, due to their healthy lifestyle, are generally felt to be at low risk of stroke and many would not be offered blood thinning treatment using risk scores used in clinical practice.

In a recent survey of almost one thousand athletes, the investigators found that there was an increased risk of stroke in those with atrial fibrillation, even in those without other risk factors for stroke.

To further investigate these findings, this study will use MRI scanning to look at the hearts and brains of athletes aged between 40-64 years old. The researchers will assess athletes with and without atrial fibrillation, as well as some athletes with atrial fibrillation who have had a stroke previously.

The MRI scans will measure heart size and function as well as blood flow patterns in the heart. The study will determine whether athletes with atrial fibrillation have evidence of stroke on brain MRI and whether these are related to abnormal flow patterns. The results will help us decide whether a larger study should be performed.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
    • Leicestershire
      • Leicester, Leicestershire, United Kingdom, LE14AY
        • Recruiting
        • Department of Cardiovascular Sciences, University of Leicester
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

- Male, competitive, veteran athletes and age/sex matched controls will be included.

Description

Inclusion Criteria:

  • Male, atrial fibrillation.
  • 40-64 years of age at the time of enrolment.
  • Primarily (≥50% of competition) competes in an endurance type sport as defined by European Society of Cardiology 2020 guidelines.
  • Competitive athlete*

  • CHA2-DS2-VAsc =0/1 (excluding previous stroke).

    • Competitive athlete defined by having trained ≥10 years, 6 hours per week as a self-reported average and having participated in at least one competitive event at regional level or above.

Exclusion Criteria:

  • History of pre-existing cardiovascular disease
  • Previous myocardial infarction, peripheral arterial disease
  • Left ventricular systolic dysfunction (EF <45%)
  • Heart muscle disease
  • Complex congenital heart disease.
  • Moderate or severe valvular disease.
  • Uncontrolled hypertension (180/100mmHg)
  • Clotting or bleeding disorders, vasculitis
  • Inherited cerebral disease
  • Known to have an estimated glomerular filtration rate <30 ml/min/1.73m2.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Athletes with atrial fibrillation without diagnosed stroke.
Diagnostic test: Cardiac and brain magnetic resonance imaging.
Cardiac magnetic resonance imaging with analysis using 4D flow. Brain magnetic resonance imaging to detect strokes, including microvascular strokes.
Athletes without atrial fibrillation.
Diagnostic test: Cardiac and brain magnetic resonance imaging.
Cardiac magnetic resonance imaging with analysis using 4D flow. Brain magnetic resonance imaging to detect strokes, including microvascular strokes.
Athletes with atrial fibrillation and a diagnosed stroke.
Diagnostic test: Cardiac and brain magnetic resonance imaging.
Cardiac magnetic resonance imaging with analysis using 4D flow. Brain magnetic resonance imaging to detect strokes, including microvascular strokes.
Healthy, non-athlete controls.
Diagnostic test: Cardiac and brain magnetic resonance imaging.
Cardiac magnetic resonance imaging with analysis using 4D flow. Brain magnetic resonance imaging to detect strokes, including microvascular strokes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stroke.
Time Frame: Baseline.
The number of participants with ischaemic white matter lesions, micro-infarcts and old infarcts.
Baseline.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac structure.
Time Frame: Baseline.
Left ventricular volume (ml).
Baseline.
Late gadolinium enhancement (LGE).
Time Frame: Baseline.
Presence of LGE. The number of participants with LGE will be compared between groups.
Baseline.
Left atrial flow-pathlines and streamlines.
Time Frame: Baseline.
Direction of pathlines and streamlines. The number of areas of stasis will be calculated for each group.
Baseline.
Cardiac function.
Time Frame: Baseline.
Ejection fraction of the left ventricular (%).
Baseline.
Left atrial stasis.
Time Frame: Baseline.
Number of areas of stasis in each group in the left atrium.
Baseline.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leicester

Investigators

  • Study Chair: Gerry P McCann, MD, MRCP(UK), MB,ChB, University of Leicester
  • Principal Investigator: Susil Pallikadavath, MRCP(UK), MBChB(hons), BSc, University of Leicester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2024

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

February 26, 2024

First Submitted That Met QC Criteria

May 20, 2024

First Posted (Actual)

May 22, 2024

Study Record Updates

Last Update Posted (Actual)

May 22, 2024

Last Update Submitted That Met QC Criteria

May 20, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0917

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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