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

Stroke Clinical Trial

— AFLETES-MRI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06424171
• Other study ID #: 0917
• Status: Recruiting
• Start date: January 22, 2024
• Est. completion date: September 30, 2024

Study information

• Verified date: January 2024
• Source: University of Leicester
• Contact: Susil Pallikadavath, MRCP(UK), MBChB(hons), BSc
• Phone: 0116 252 2522
• Email: susil.pallikadavath[@]leicester.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Stroke

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Department of Cardiovascular Sciences, University of Leicester	Leicester	Leicestershire

Sponsors (1)

Lead Sponsor	Collaborator
University of Leicester

Country where clinical trial is conducted

United Kingdom, 

References & Publications (14)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Int J Stroke. 2020 Jan 28;:1747493020905964. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Eur Heart J. 2021 Feb 1;42(5):548-549. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stroke.	The number of participants with ischaemic white matter lesions, micro-infarcts and old infarcts.	Baseline.
Secondary	Cardiac structure.	Left ventricular volume (ml).	Baseline.
Secondary	Late gadolinium enhancement (LGE).	Presence of LGE. The number of participants with LGE will be compared between groups.	Baseline.
Secondary	Left atrial flow-pathlines and streamlines.	Direction of pathlines and streamlines. The number of areas of stasis will be calculated for each group.	Baseline.
Secondary	Cardiac function.	Ejection fraction of the left ventricular (%).	Baseline.
Secondary	Left atrial stasis.	Number of areas of stasis in each group in the left atrium.	Baseline.