Sudden Cardiac Death Clinical Trial
Official title:
The Prevalence and Significance of Low QRS Voltages in Young Healthy Individuals and Athletes
There is some limited evidence that reduced size of electrical complexes/traces of the heart on the electrocardiogram (ECG) may be associated with scarring in the heart muscle, which may predispose to serious life-threatening electrical abnormalities and sudden cardiac death (SCD). There is no current guidance on how young individuals and athletes with reduced ECG traces should be managed. Therefore, correct interpretation of this ECG finding is crucial for identifying athletes with disease and at risk of SCD. Some athletes experience SCD despite normal standard cardiac tests. The investigators, therefore, propose to study young healthy individuals and young athletes using cardiovascular MRI, cardiopulmonary exercise testing, 24 hour ECG monitoring and genetic analysis to determine the significance of reduced ECG traces and possibly revise current international sports recommendations.
Status | Recruiting |
Enrollment | 240 |
Est. completion date | November 1, 2025 |
Est. primary completion date | May 1, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 17 Years to 35 Years |
Eligibility | Inclusion Criteria: - No cardiovascular symptoms - Body mass index <30. Exclusion Criteria: - Individuals with cardiac symptoms; - Past medical history of cardiac disease, previous myocarditis or lung disease; - Individuals with pacemakers or defibrillators - Family history of SCD <40 years old or cardiomyopathy - Pregnant women - Advanced kidney and/or liver disease - Known thyroid disease, - T-wave inversion or other training unrelated ECG changes - Known significant valvular heart disease or intra-cardiac shunt on echocardiography. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Brompton Hospital | London |
Lead Sponsor | Collaborator |
---|---|
Imperial College London | Cardiac Risk in the Young, Royal Brompton & Harefield NHS Foundation Trust, St George's, University of London |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevalence of low QRS voltages in athletes and young non-athletic population on ECG analysis | Prevalence data will be obtained from existing ECG database of athletes and young people who have been screened by Cardiac risk in the young. | 36 months | |
Primary | Prevalence of myocardial fibrosis in the young athletic and non-athletic population with low QRS | Participants satisfying inclusion criteria will undergo a cardiac MRI at a single time point to identify those with late gadolinium enhancement (indication of myocardial fibrosis) | 36 months | |
Secondary | The proportion of individuals with low QRS complexes and myocardial fibrosis with rare protein altering variant in a cardiomyopathy gene. | A subgroup of athletes and young health individuals with low QRS voltages and myocardial fibrosis on cardiac MRI will undergo genetic analysis to identify the presence of protein altering genetic variants in known cardiomyopathy causing genes | 36 months | |
Secondary | The proportion of individuals with low QRS complexes and myocardial fibrosis with exercise related ventricular premature beats or a ventricular premature beat burden of > 500 beats on a Holter monitor | All participants will undergo cardiopulmonary exercise tests and 24 hour holter monitoring to identify presence of exercise related ventricular premature beats and a ventricular premature beat burden of > 500 beats on a Holter monitor | 36 months |
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