Low QRS Voltages in Young Healthy Individuals and Athletes

NCT05799833 | Unknown

• 2 other identifiers: 22IC7985WHCC_PA2965
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sudden Cardiac Death; Sudden Cardiac Arrest; Sudden Cardiac Death Due to Cardiac Arrhythmia; Arrhythmogenic Right Ventricular Cardiomyopathy; Arrhythmogenic Left Ventricular Cardiomyopathy; Dilated Cardiomyopathy

Keywords

Low QRS Voltage; Low QRS amplitude; Sudden Cardiac Death; Cardiac magnetic resonance; Myocardial fibrosis; Premature Ventricular complexes; Dilated Cardiomyopathy; Arrythmogenic right ventricular cardiomyopathy; Arrhythmogenic Left Ventricular Cardiomyopathy; Late Gadolinium Enhancement; Implantable cardioverter defibrillator; Cardiopulmonary exercise testing; Athletes; Genetic inheritance; Non sustained ventricular tachycardia; Pre participation screening; Sports screening

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• The proportion of individuals with low QRS complexes and myocardial fibrosis with rare protein altering variant in a cardiomyopathy gene.

  36 months

• 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

  36 months

Study Arms (4)

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)

Diagnostic Test: Cardiovascular magnetic resonance scan - 3T scanner (Siemens Vida)

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)

Diagnostic Test: Cardiovascular magnetic resonance scan - 3T scanner (Siemens Vida)

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.

Diagnostic Test: Cardiovascular magnetic resonance scan - 3T scanner (Siemens Vida)

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.

Diagnostic Test: Cardiovascular magnetic resonance scan - 3T scanner (Siemens Vida)

Interventions

Cardiovascular magnetic resonance scan - 3T scanner (Siemens Vida) DIAGNOSTIC_TEST

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.

Also known as: Cardiopulmonary exercise test - COSMED E100w upright cycle ergometer, 24 hour holter monitor - Lifecard CF Holters, Blood test for thyroid function and genetic testing (whole exome sequencing on the Illumina sequencing platform)

Age and sex matched control group of athletes with normal QRS voltage; Age and sex matched young healthy controls (non-athletes) with normal QRS voltage; Athletes with low QRS voltage; Young healthy individuals (non-athletes) with low QRS voltage

Eligibility Criteria

• Age: 17 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

240 total study population: * 60 athletes with low QRS voltage and 60 age and sex matched control group of athletes with normal QRS voltage * 60 non-athletes with low QRS voltage and 60 age and sex matched controls with normal QRS voltage

You may qualify if:

• No cardiovascular symptoms
• Body mass index \<30.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imperial College London: lead
• Royal Brompton & Harefield NHS Foundation Trust: collaborator
• Cardiac Risk in the Young: collaborator
• St George's, University of London: collaborator

Study Sites (1)

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples obtained from each participant for the purpose of performing genetic testing to identify protein altering genetic variants in known genes associated with ARVC/DCM.

MeSH Terms

Conditions

Death, Sudden, Cardiac; Arrhythmogenic Right Ventricular Dysplasia; Cardiomyopathy, Dilated; Ventricular Premature Complexes

Interventions

Hematologic Tests; Genetic Testing

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiomyopathies; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cardiomegaly; Laminopathies; Genetic Diseases, Inborn; Cardiac Complexes, Premature; Arrhythmias, Cardiac; Cardiac Conduction System Disease

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Study Officials

• Sabiha Gati, MBBS

  Royal Brompton & Harefield NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sabiha Gati, MBBS

CONTACT

07977 352296; s.gati@rbht.nhs.uk

Nirmitha Jayaratne-Sandhu, MBBS

CONTACT

07977 352296; n.jayaratne@rbht.nhs.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: April 5, 2023
• Study Start: October 9, 2023
• Primary Completion: May 1, 2025
• Study Completion: November 1, 2025
• Last Updated: October 4, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)