ULTIMATE-Athlete V1.0
Research type
Research Study
Full title
Utilizing LifeMap To Investigate Malignant Arrhythmia Therapeutic Efficacy in Athletes (ULTIMATE-Athlete)
IRAS ID
348835
Contact name
G. André Ng
Contact email
Sponsor organisation
University of Leicester
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 1 months, 31 days
Research summary
This research aims to investigate a novel ECG-based technology, LifeMap, in predicting malignant arrhythmia in athletes. The study is important because sudden cardiac death (SCD) is a significant concern in athletes, and current tools for identifying high-risk individuals are limited. This could help prevent unnecessary intervention in high-risk people that exercise frequently, whilst identifying those in low risk group who previously would not have benefited from implantable cardioverter defibrillator (ICD) therapy. The study focuses on cardiac arrhythmia and the use of ICDs in athletes. It will test LifeMap's ability to measure electrical restitution markers (R2I2 and PERS) using non-invasive methods. Eligible participants are physically active individuals aged 18 and over who engage in at least 3 hours of weekly physical activity for recreation, occupation, or competition. The study will include athletes with ICDs (cases) and those with pacemakers or no cardiac devices (controls). The research will be conducted at University Hospitals Leicester NHS Trust, utilising their cardiac device clinic. Participants will undergo procedures for 60 mins, but participants will be at the hospital for about half a day (3 to 4 hours) in a University of Leicester embedded space in UHL. These procedures include: 1. Informed consent and demographic data collection 2. Vital signs and non-invasive cardiac assessments 3. 12-lead ECG recordings 4. Non-invasive programmed stimulation (for those with ICDs or pacemakers) 5. Exercise stress test 6. Overnight Holter ECG monitoring The study aims to recruit at least 40 participants (about 10% of the calculated full sample size) as a pilot study. The study is expected to last from June 2025 to July 2026. The study maybe completed earlier once desired recruitment goal is reached.
REC name
London - Queen Square Research Ethics Committee
REC reference
25/PR/0802
Date of REC Opinion
16 Jul 2025
REC opinion
Further Information Favourable Opinion