## Protocol Section
### Identification Module
**NCT ID:** NCT06424171

**Acronym:** AFLETES-MRI

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

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

#### Organization Study ID Info
**ID:** 0917
#### Organization
**Class:** OTHER
**Full Name:** University of Leicester
### Status Module
#### Completion Date
**Date:** 2024-09-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-09-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-01-22

**Type:** ACTUAL

**Status Verified Date:** 2024-01

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-02-26
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Leicester

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Atrial Fibrillation

- Stroke

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 64

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Diagnostic Test: Cardiac and brain magnetic resonance imaging.

**Label:** Athletes with atrial fibrillation without diagnosed stroke.

#### Arm Group 2

**Intervention Names:**

- Diagnostic Test: Cardiac and brain magnetic resonance imaging.

**Label:** Athletes without atrial fibrillation.

#### Arm Group 3

**Intervention Names:**

- Diagnostic Test: Cardiac and brain magnetic resonance imaging.

**Label:** Athletes with atrial fibrillation and a diagnosed stroke.

#### Arm Group 4

**Intervention Names:**

- Diagnostic Test: Cardiac and brain magnetic resonance imaging.

**Label:** Healthy, non-athlete controls.

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Athletes with atrial fibrillation and a diagnosed stroke.

- Athletes with atrial fibrillation without diagnosed stroke.

- Athletes without atrial fibrillation.

- Healthy, non-athlete controls.

**Description:** Cardiac magnetic resonance imaging with analysis using 4D flow. Brain magnetic resonance imaging to detect strokes, including microvascular strokes.

**Name:** Cardiac and brain magnetic resonance imaging.

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Stroke.

**Time Frame:** Baseline.

#### Secondary Outcomes

**Description:** Left ventricular volume (ml).

**Measure:** Cardiac structure.

**Time Frame:** Baseline.

**Description:** Presence of LGE. The number of participants with LGE will be compared between groups.

**Measure:** Late gadolinium enhancement (LGE).

**Time Frame:** Baseline.

**Description:** Direction of pathlines and streamlines. The number of areas of stasis will be calculated for each group.

**Measure:** Left atrial flow-pathlines and streamlines.

**Time Frame:** Baseline.

**Description:** Ejection fraction of the left ventricular (%).

**Measure:** Cardiac function.

**Time Frame:** Baseline.

**Description:** Number of areas of stasis in each group in the left atrium.

**Measure:** Left atrial stasis.

**Time Frame:** Baseline.

### Eligibility Module

**Eligibility Criteria:** 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.

**Healthy Volunteers:** True

**Maximum Age:** 64 Years

**Minimum Age:** 40 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** MALE

**Standard Ages:**

- ADULT

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

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** susil.pallikadavath@leicester.ac.uk

**Name:** Susil Pallikadavath, MRCP(UK), MBChB(hons), BSc

**Phone:** 0116 252 2522

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Leicester

**Contacts:**

***Contact 1:***

- **Email:** susil.pallikadavath@leicester.ac.uk

- **Name:** Susil Pallikadavath, MRCP(UK), MBChB(hons), BSc

- **Phone:** +447926082259

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** Department of Cardiovascular Sciences, University of Leicester

**State:** Leicestershire

**Status:** RECRUITING

**Zip:** LE14AY

#### Overall Officials

**Official 1:**

**Affiliation:** University of Leicester

**Name:** Gerry P McCann, MD, MRCP(UK), MB,ChB

**Role:** STUDY_CHAIR

**Official 2:**

**Affiliation:** University of Leicester

**Name:** Susil Pallikadavath, MRCP(UK), MBChB(hons), BSc

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**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.

**PMID:** 34253538

**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.

**PMID:** 37042823

**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.

**PMID:** 26257141

**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.

**PMID:** 31955707

**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.

**PMID:** 32117002

**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.

**PMID:** 30167977

**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.

**PMID:** 30927959

**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.

**PMID:** 29246514

**Citation:** 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

**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.

**PMID:** 34143872

**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.

**PMID:** 25391258

**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.

**PMID:** 23292793

**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.

**PMID:** 26590397

**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.

**PMID:** 32860412

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000001145

- Term: Arrhythmias, Cardiac

- ID: D000006331

- Term: Heart Diseases

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M22306

- Name: Stroke

- Relevance: LOW

- As Found: Unknown

- ID: M4586

- Name: Atrial Fibrillation

- Relevance: HIGH

- As Found: Atrial Fibrillation

- ID: M4453

- Name: Arrhythmias, Cardiac

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001281

- Term: Atrial Fibrillation

### Misc Info Module

- Version Holder: 2024-05-31
