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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Leicester

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

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).

Trial population

Study population will be from a single tertiary care hospital (University Hospitals Leicester), and residents of United Kingdom

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

40 Participants
are grouped into 3 trial groups
Group A: Participants with ICD
Group B: Participants without heart device
Group C: Participants with Pacemaker

Trial outcomes

Primary outcomes

1

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 outcomes

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).

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: