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| ID | Type | Description | Link |
|---|---|---|---|
| NIHR203327 | Other Grant/Funding Number | National Institute for Health and Care Research Leicester Biomedical Research Centre |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with ICD | Those that exercise 3 hours or more per week and/or have a physically active occupation (e.g military, fire service, landscaper, etc.) and have been identified as at risk of sudden cardiac death. Therefore have been implanted with an implantable defibrillator (ICD) for primary or secondary prevention. | ||
| Participants without heart device | Those that exercise 3 hours or more per week and/or have a physically active occupation (e.g military, fire service, landscaper, etc.) and do not have any heart condition. Therefore have not been implanted with any heart device. | ||
| Participants with Pacemaker | Those that exercise 3 hours or more per week and/or have a physically active occupation (e.g military, fire service, landscaper, etc.) and have not been identified as at risk of sudden cardiac death. Therefore do not have an implantable cardioverter defibrillator, but have been implanted with a cardiac pacemaker due to other conditions. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Restitution Markers as Determined by R2I2 and PERS | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Non-invasive exercise-based tests correlate with electrophysiology study. | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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Study population will be from a single tertiary care hospital (University Hospitals Leicester), and residents of United Kingdom
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Abdulmalik I Koya, MD | Contact | +4407990290755 | aik8@leicester.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Ghulam André Ng, MBChB, MRCP, Ph.D, FRCP | University of Leicester, Leicestershire, United Kingdom | Study Director |
| Ghulam André Ng, MBChB, MRCP, Ph.D, FRCP, FHEA | University of Leicester, Leicestershire, United Kingdom |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glenfield Hospital | Leicester | Leicestershire | LE3 9QP | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33336815 | Background | 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. | |
| 29684162 | Background | 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. |
| Label | URL |
|---|---|
| LifeMap is a novel, highly promising technique for assessing risk of sudden cardiac death, a condition that kills 3 million people annually | View source |
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Undecided yet due to study committee and study sponsor needing to deliberate
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| Xin Li, PhD, MSc, BSc, FHEA | University of Leicester, Leicestershire, United Kingdom | Principal Investigator |
| Harshil Dhutia, MBBS, BSC, MRCP, CCDS, MD(RES) | Glenfield Hospital, Leicester | Principal Investigator |
| ID | Term |
|---|---|
| D016757 | Death, Sudden, Cardiac |
| D014693 | Ventricular Fibrillation |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D003645 | Death, Sudden |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001145 | Arrhythmias, Cardiac |
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