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Not yet recruiting NCT07014579

Using Heart Electrical Signals to Study How Well Treatments Prevent Dangerous Heart Rhythms in Active People

— Observational Inherited Cardiac Conditions Sudden Cardiac Arrest Ventricular Arrhythmia Athlete

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Inherited Cardiac Conditions, Sudden Cardiac Arrest, Ventricular Arrhythmia, Athlete. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Utilizing LifeMap To Investigate Malignant Arrhythmia Therapeutic Efficacy in Athletes

Overview

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.

Primary outcome measures

  • Change in Restitution Markers as Determined by R2I2 and PERS [Time frame: 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 outcome measures (1)
  • Non-invasive exercise-based tests correlate with electrophysiology study. [Time frame: 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).]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

United Kingdom · 1 center
  • Glenfield Hospital — Leicester

Publications

  • 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. PMID 33336815
  • 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. PMID 29684162

Identifiers

NCT: NCT07014579 · 1037 · NIHR203327

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗