Low QRS Voltages in Young Healthy Individuals and Athletes
NCT ID: NCT05799833
Last Updated: 2023-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
240 participants
OBSERVATIONAL
2023-10-09
2025-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Athletes with low QRS voltage
Cohort (anticipated N = 60) will undergo testing with 12 lead ECG, blood test, cardiac MRI, 24 hour holter monitoring and cardiopulmonary exercise testing.
A subgroup of those identified to have low QRS voltage and myocardial scar on CMR will undergo genetic testing (anticipated number to be tested, N= 25)
Cardiovascular magnetic resonance scan - 3T scanner (Siemens Vida)
4 study groups will undergo testing with 12-lead ECG, blood test, cardiac MRI, cardiopulmonary exercise testing and 24 hour holter monitor. A subgroup (N=50 anticipated) will undergo genetic testing.
Young healthy individuals (non-athletes) with low QRS voltage
Cohort (anticipated N = 60) will undergo testing with 12 lead ECG, blood test, cardiac MRI, 24 hour holter monitoring and cardiopulmonary exercise testing.
A subgroup of those identified to have low QRS voltage and myocardial scar on CMR will undergo genetic testing (anticipated number to be tested, N= 25)
Cardiovascular magnetic resonance scan - 3T scanner (Siemens Vida)
4 study groups will undergo testing with 12-lead ECG, blood test, cardiac MRI, cardiopulmonary exercise testing and 24 hour holter monitor. A subgroup (N=50 anticipated) will undergo genetic testing.
Age and sex matched control group of athletes with normal QRS voltage
Cohort (anticipated N = 60) will undergo testing with 12 lead ECG, blood test, cardiac MRI, 24 hour holter monitoring and cardiopulmonary exercise testing.
Cardiovascular magnetic resonance scan - 3T scanner (Siemens Vida)
4 study groups will undergo testing with 12-lead ECG, blood test, cardiac MRI, cardiopulmonary exercise testing and 24 hour holter monitor. A subgroup (N=50 anticipated) will undergo genetic testing.
Age and sex matched young healthy controls (non-athletes) with normal QRS voltage
Cohort (anticipated N = 60) will undergo testing with 12 lead ECG, blood test, cardiac MRI, 24 hour holter monitoring and cardiopulmonary exercise testing.
Cardiovascular magnetic resonance scan - 3T scanner (Siemens Vida)
4 study groups will undergo testing with 12-lead ECG, blood test, cardiac MRI, cardiopulmonary exercise testing and 24 hour holter monitor. A subgroup (N=50 anticipated) will undergo genetic testing.
Interventions
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Cardiovascular magnetic resonance scan - 3T scanner (Siemens Vida)
4 study groups will undergo testing with 12-lead ECG, blood test, cardiac MRI, cardiopulmonary exercise testing and 24 hour holter monitor. A subgroup (N=50 anticipated) will undergo genetic testing.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body mass index \<30.
Exclusion Criteria
* 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.
17 Years
35 Years
ALL
Yes
Sponsors
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Royal Brompton & Harefield NHS Foundation Trust
OTHER
Cardiac Risk in the Young
OTHER
St George's, University of London
OTHER
Imperial College London
OTHER
Responsible Party
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Principal Investigators
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Sabiha Gati, MBBS
Role: PRINCIPAL_INVESTIGATOR
Royal Brompton & Harefield NHS Foundation Trust
Locations
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Royal Brompton Hospital
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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WHCC_PA2965
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
22IC7985
Identifier Type: -
Identifier Source: org_study_id
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