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

NCT06424171 | Unknown

• 1 other identifier: 0917
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation; Stroke

Outcome Measures

Primary Outcomes (1)

• Stroke.

  The number of participants with ischaemic white matter lesions, micro-infarcts and old infarcts.

  Baseline.

Secondary Outcomes (5)

• Cardiac structure.

  Baseline.

• Late gadolinium enhancement (LGE).

  Baseline.

• Left atrial flow-pathlines and streamlines.

  Baseline.

• Cardiac function.

  Baseline.

• Left atrial stasis.

  Baseline.

Study Arms (4)

Athletes with atrial fibrillation without diagnosed stroke.

Diagnostic Test: Cardiac and brain magnetic resonance imaging.

Athletes without atrial fibrillation.

Diagnostic Test: Cardiac and brain magnetic resonance imaging.

Athletes with atrial fibrillation and a diagnosed stroke.

Diagnostic Test: Cardiac and brain magnetic resonance imaging.

Healthy, non-athlete controls.

Diagnostic Test: Cardiac and brain magnetic resonance imaging.

Interventions

Cardiac and brain magnetic resonance imaging. DIAGNOSTIC_TEST

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.; Athletes with atrial fibrillation without diagnosed stroke.; Athletes without atrial fibrillation.; Healthy, non-athlete controls.

Eligibility Criteria

• Age: 40 Years - 64 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Male, atrial fibrillation.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Leicester: lead

Study Sites (1)

Department of Cardiovascular Sciences, University of Leicester

Leicester, Leicestershire, LE14AY, United Kingdom

RECRUITING

Related Publications (14)

• Newman W, Parry-Williams G, Wiles J, Edwards J, Hulbert S, Kipourou K, Papadakis M, Sharma R, O'Driscoll J. Risk of atrial fibrillation in athletes: a systematic review and meta-analysis. Br J Sports Med. 2021 Nov;55(21):1233-1238. doi: 10.1136/bjsports-2021-103994. Epub 2021 Jul 12.

  PMID: 34253538 BACKGROUND

• Pallikadavath S, Richards C, Bountziouka V, Sandilands AJ, Graham-Brown MPM, Robinson T, Singh A, McCann GP. The AFLETES Study: Atrial Fibrillation in Veteran Athletes and the Risk of Stroke. Clin J Sport Med. 2023 May 1;33(3):209-216. doi: 10.1097/JSM.0000000000001115. Epub 2023 Apr 6.

  PMID: 37042823 BACKGROUND

• Dyverfeldt P, Bissell M, Barker AJ, Bolger AF, Carlhall CJ, Ebbers T, Francios CJ, Frydrychowicz A, Geiger J, Giese D, Hope MD, Kilner PJ, Kozerke S, Myerson S, Neubauer S, Wieben O, Markl M. 4D flow cardiovascular magnetic resonance consensus statement. J Cardiovasc Magn Reson. 2015 Aug 10;17(1):72. doi: 10.1186/s12968-015-0174-5.

  PMID: 26257141 BACKGROUND

• Lippi G, Sanchis-Gomar F, Cervellin G. Global epidemiology of atrial fibrillation: An increasing epidemic and public health challenge. Int J Stroke. 2021 Feb;16(2):217-221. doi: 10.1177/1747493019897870. Epub 2020 Jan 19.

  PMID: 31955707 BACKGROUND

• Xu Y, Zhao L, Zhang L, Han Y, Wang P, Yu S. Left Atrial Enlargement and the Risk of Stroke: A Meta-Analysis of Prospective Cohort Studies. Front Neurol. 2020 Feb 14;11:26. doi: 10.3389/fneur.2020.00026. eCollection 2020.

  PMID: 32117002 BACKGROUND

• Androulakis E, Swoboda PP. The Role of Cardiovascular Magnetic Resonance in Sports Cardiology; Current Utility and Future Perspectives. Curr Treat Options Cardiovasc Med. 2018 Aug 31;20(10):86. doi: 10.1007/s11936-018-0679-y.

  PMID: 30167977 BACKGROUND

• Graham-Brown MP, Gulsin GS, Parke K, Wormleighton J, Lai FY, Athithan L, Arnold JR, Burton JO, McCann GP, Singh AS. A comparison of the reproducibility of two cine-derived strain software programmes in disease states. Eur J Radiol. 2019 Apr;113:51-58. doi: 10.1016/j.ejrad.2019.01.026. Epub 2019 Jan 23.

  PMID: 30927959 BACKGROUND

• D'Ascenzi F, Anselmi F, Focardi M, Mondillo S. Atrial Enlargement in the Athlete's Heart: Assessment of Atrial Function May Help Distinguish Adaptive from Pathologic Remodeling. J Am Soc Echocardiogr. 2018 Feb;31(2):148-157. doi: 10.1016/j.echo.2017.11.009. Epub 2017 Dec 13.

  PMID: 29246514 BACKGROUND

• Androulakis E, Mouselimis D, Tsarouchas A, Antonopoulos A, Bakogiannis C, Papagkikas P, Vlachopoulos C. The Role of Cardiovascular Magnetic Resonance Imaging in the Assessment of Myocardial Fibrosis in Young and Veteran Athletes: Insights From a Meta-Analysis. Front Cardiovasc Med. 2021 Dec 21;8:784474. doi: 10.3389/fcvm.2021.784474. eCollection 2021.

  PMID: 34993239 BACKGROUND

• Demirkiran A, van Ooij P, Westenberg JJM, Hofman MBM, van Assen HC, Schoonmade LJ, Asim U, Blanken CPS, Nederveen AJ, van Rossum AC, Gotte MJW. Clinical intra-cardiac 4D flow CMR: acquisition, analysis, and clinical applications. Eur Heart J Cardiovasc Imaging. 2022 Jan 24;23(2):154-165. doi: 10.1093/ehjci/jeab112.

  PMID: 34143872 BACKGROUND

• Suwa K, Saitoh T, Takehara Y, Sano M, Nobuhara M, Saotome M, Urushida T, Katoh H, Satoh H, Sugiyama M, Wakayama T, Alley M, Sakahara H, Hayashi H. Characteristics of intra-left atrial flow dynamics and factors affecting formation of the vortex flow - analysis with phase-resolved 3-dimensional cine phase contrast magnetic resonance imaging. Circ J. 2015;79(1):144-52. doi: 10.1253/circj.CJ-14-0562. Epub 2014 Nov 13.

  PMID: 25391258 BACKGROUND

• Fluckiger JU, Goldberger JJ, Lee DC, Ng J, Lee R, Goyal A, Markl M. Left atrial flow velocity distribution and flow coherence using four-dimensional FLOW MRI: a pilot study investigating the impact of age and Pre- and Postintervention atrial fibrillation on atrial hemodynamics. J Magn Reson Imaging. 2013 Sep;38(3):580-7. doi: 10.1002/jmri.23994. Epub 2013 Jan 4.

  PMID: 23292793 BACKGROUND

• Lee DC, Markl M, Ng J, Carr M, Benefield B, Carr JC, Goldberger JJ. Three-dimensional left atrial blood flow characteristics in patients with atrial fibrillation assessed by 4D flow CMR. Eur Heart J Cardiovasc Imaging. 2016 Nov;17(11):1259-1268. doi: 10.1093/ehjci/jev304. Epub 2015 Nov 20.

  PMID: 26590397 BACKGROUND

• Pelliccia A, Sharma S, Gati S, Back M, Borjesson M, Caselli S, Collet JP, Corrado D, Drezner JA, Halle M, Hansen D, Heidbuchel H, Myers J, Niebauer J, Papadakis M, Piepoli MF, Prescott E, Roos-Hesselink JW, Graham Stuart A, Taylor RS, Thompson PD, Tiberi M, Vanhees L, Wilhelm M; ESC Scientific Document Group. 2020 ESC Guidelines on sports cardiology and exercise in patients with cardiovascular disease. Eur Heart J. 2021 Jan 1;42(1):17-96. doi: 10.1093/eurheartj/ehaa605. No abstract available.

  PMID: 32860412 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation; Stroke

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• Gerry P McCann, MD, MRCP(UK), MB,ChB

  University of Leicester

  STUDY CHAIR

• Susil Pallikadavath, MRCP(UK), MBChB(hons), BSc

  University of Leicester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susil Pallikadavath, MRCP(UK), MBChB(hons), BSc

CONTACT

0116 252 2522; susil.pallikadavath@leicester.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: May 22, 2024
• Study Start: January 22, 2024
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: May 22, 2024

Record last verified: 2024-01

Locations

GB (1)