Clinical trial NCT07014579: Using Heart Electrical Signals to Study How Well Treatments Prevent Dangerous Heart Rhythms in Active People
Official title: Utilizing LifeMap To Investigate Malignant Arrhythmia Therapeutic Efficacy in Athletes
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Inherited Cardiac Conditions
Sudden Cardiac Arrest
Ventricular Arrhythmia
Athlete
Ventricular Fibrillation
Keywords: ULTIMATE-Athlete
LifeMap
R2I2
PERS
Ventricular Arrhythmia
Ventricular Fibrillation
Sudden Cardiac Death
Lead sponsor: University of Leicester
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will be from a single tertiary care hospital (University Hospitals Leicester), and residents of United Kingdom

Brief summary: The goal of this observational study is to learn if two specific heart electrical signal patterns can help in detecting the risk of dangerous heart rhythms in athletes, and to see if exercise-based tests can be used instead of invasive hospital procedures to record this electrical signals.

The main questions it aims to answer are:

1. Can special ECG action potential duration markers (R2I2 and PERS) identify athletes who are at higher risk of sudden heart rhythm problems.
2. Can an exercise test give the same information as a non-invasive electrophysiology study.

Researchers will compare athletes who have an implanted heart device (ICD) with athletes who do not, to see if there are differences in these heart signals.

Participants will undergo:

1. ECG recordings during rest and exercise.
2. If they have an ICD or pacemaker, an ECG will be recorded during a non invasive stimulation.
3. A continuous 24 hour ECG.


Eligibility criteria: Inclusion Criteria:

* Age 18 and over.
* Participates in regular physical activity for at least 3 hours or greater weekly.
* Having Implantable cardioverter defibrillator insitu (cases).
* Having a cardiac pacemaker (control).
* Having no cardiac device (control).
* Sufficient capacity and agreement to participate orally and signed written consent forms.
* Understanding of written and spoken English language.

Exclusion Criteria:

* Pregnancy, as detected by positive urine pregnancy test result.
* Inability to comply with study protocols.
* Any iatrogenic cardiac pathology (stents, CABG etc).
* Unstable ventricular tachycardia (\>30 seconds).
* Any unstable malignant arrhythmia.
* Fever or presence of a clinically diagnosed febrile illness

Primary outcomes:
measure: Change in Restitution Markers as Determined by R2I2 and PERS
timeFrame: The primary outcome measure is assessment of changes in the regional restitution instability index and peak ECG restitution slope at various time points including, baseline, during 15-minute exercise and during 15-minute electrophysiology study.
Secondary outcomes:
measure: Non-invasive exercise-based tests correlate with electrophysiology study.
timeFrame: The secondary outcome looks at how the Regional Restitution Instability Index (R2I2) and Peak ECG restitution slope (PERS) measurements during a 15-minute exercise compare with those taken during 15 minute Non-Invasive Programmed Stimulation (NIPS).
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: Glenfield Hospital
state: Leicestershire
Study officials:
affiliation: University of Leicester, Leicestershire, United Kingdom
name: Ghulam André Ng, MBChB, MRCP, Ph.D, FRCP
role: STUDY_DIRECTOR
affiliation: University of Leicester, Leicestershire, United Kingdom
name: Ghulam André Ng, MBChB, MRCP, Ph.D, FRCP, FHEA
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Leicester, Leicestershire, United Kingdom
name: Xin Li, PhD, MSc, BSc, FHEA
role: PRINCIPAL_INVESTIGATOR
affiliation: Glenfield Hospital, Leicester
name: Harshil Dhutia, MBBS, BSC, MRCP, CCDS, MD(RES)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nicolson WB, Smith MI, Vali Z, Samani NJ, Ng GA. Application of two novel electrical restitution-based ECG markers of ventricular arrhythmia to patients with nonischemic cardiomyopathy. Pacing Clin Electrophysiol. 2021 Feb;44(2):284-292. doi: 10.1111/pace.14143. Epub 2021 Jan 4.
citation: Ng GA, Mistry A, Li X, Schlindwein FS, Nicolson WB. LifeMap: towards the development of a new technology in sudden cardiac death risk stratification for clinical use. Europace. 2018 Sep 1;20(FI2):f162-f170. doi: 10.1093/europace/euy080.