Sudden Cardiac DeathNCT05799833
Low QRS Voltages in Young Healthy Individuals and Athletes
An observational study of Sudden Cardiac Death and Sudden Cardiac Arrest, run by Imperial College London at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 17 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Sudden Cardiac Death, Sudden Cardiac Arrest, Sudden Cardiac Death Due to Cardiac Arrhythmia
- What is being tested?
- Cardiovascular magnetic resonance scan - 3T scanner (Siemens Vida)
- How many people
- 240 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Oct 2023to 1 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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
Who may be able to join
- No cardiovascular symptoms
- Body mass index <30.
Who cannot join
- 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
Show all 9Show fewer
- Known thyroid disease,
- T-wave inversion or other training unrelated ECG changes
- Known significant valvular heart disease or intra-cardiac shunt on echocardiography.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Brompton Hospital
London, SW3 6NP
Sabiha Gati, MBBS, 07977352296, s.gati@rbht.nhs.uk
Nirmitha Jayaratne-Sandhu, MBBS, 07977352296, n.jayaratne@rbht.nhs.uk
About this study
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.
Read the detailed description
There is emerging evidence that low QRS voltages <0.5mV in the limb leads may be associated with left ventricular myocardial fibrosis and a predisposition to serious ventricular arrhythmias and sudden cardiac death (SCD). Sudden death in young individuals is highlighted most commonly when an athlete is affected. A proportion of decedents are diagnosed with idiopathic myocardial fibrosis at autopsy. Recent studies have revealed myocardial fibrosis in athletes with low QRS complexes, who have survived a sudden cardiac arrest. Low QRS voltages do not feature in the electrical anomalies that warrant further investigation according to the international recommendations for electrocardiographic (ECG) interpretation in athletes, hence there is no information on the precise significance or outcome data in athletes with small QRS voltages. The investigators postulate that further evaluation of athletes with low QRS voltages using CMR and gene analysis will help determine the prevalence and significance of these ECG changes potentially identifying young vulnerable individuals at risk of SCD. There are currently 2 studies which have assessed small QRS complexes in athletes. These studies revealed 1.1-4% of Italian athletes had small QRS complexes. One study performed ultrasound of the heart showing that athletes in general had larger hearts compared to sedentary counterparts but no evidence of structural disease. The second study did not perform CMR in all athletes with small QRS complexes and only conducted CMR in 5 athletes with small QRS complexes and electrical issues and demonstrated scar in 2 athletes. The scientific basis of these studies does not prove the precise significance of small QRS complexes on the ECG in this population to elucidate the sensitivity and specificity of disease identification. It is possible that young individuals with serious cardiac abnormalities may be identified if the significance of small QRS complexes is elucidated. The prevalence of small QRS complexes in the general population is 0.3-2% but there is paucity of data on prevalence and significance on small QRS complexes in young non-athletic individuals aged 17-35 years old. This study will allow the investigators to identify the prevalence and significance of small QRS complexes in athletes and non-athletes aged 17-35 years old potentially identifying young vulnerable individuals at risk of sudden cardiac death. These results should enable informed clinical decisions (at national and international level) following pre-participation screening evaluation and help ultimately to identify young individuals and athletes who are genuinely deemed to be at risk of sudden cardiac death (SCD) whilst providing appropriate reassurance to those with normal QRS voltages. This study will also potentially aid the investigators in updating the current recommendations on ECG interpretation in athletes which will influence future international ECG recommendations in athletes.This would be a cross-sectional observational study involving 240 participants aged 17-35 years old. This will involve 4 groups; 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.
- Conditions
- Sudden Cardiac Death, Sudden Cardiac Arrest, Sudden Cardiac Death Due to Cardiac Arrhythmia, Arrhythmogenic Right Ventricular Cardiomyopathy, Arrhythmogenic Left Ventricular Cardiomyopathy, Dilated Cardiomyopathy
- Being tested
- Cardiovascular magnetic resonance scan - 3T scanner (Siemens Vida)
- 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
- Medical subject headings
- Death, Sudden, Cardiac, Arrhythmogenic Right Ventricular Dysplasia, Cardiomyopathy, Dilated, Ventricular Premature Complexes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular magnetic resonance scan - 3T scanner (Siemens Vida)Diagnostic test
Also called 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)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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. Receives: 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. Receives: Diagnostic Test: Cardiovascular magnetic resonance scan - 3T scanner (Siemens Vida) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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.
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
Measured: 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
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
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start9 Oct 2023 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden Cardiac DeathStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Brompton & Harefield NHS Foundation Trust, Cardiac Risk in the Young, St George's, University of London
- Responsible party
- Sponsor
- Investigators
- Sabiha Gati, MBBS, Principal investigator, Royal Brompton & Harefield NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799833
- Sponsor's protocol ID
- 22IC7985
- Other IDs
- WHCC_PA2965
- Status last verified
- Oct 2023
- First submitted
- 23 Mar 2023
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence and Significance of Low QRS Voltages in Young Healthy Individuals and Athletes
- ClinicalTrials.gov ID
- NCT05799833
- Acronym / sponsor ID
- 22IC7985
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Royal Brompton & Harefield NHS Foundation Trust, Cardiac Risk in the Young, St George's, University of London
- Study start
- 9 Oct 2023 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 5 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
There is emerging evidence that low QRS voltages <0.5mV in the limb leads may be associated with left ventricular myocardial fibrosis and a predisposition to serious ventricular arrhythmias and sudden cardiac death (SCD). Sudden death in young individuals is highlighted most commonly when an athlete is affected. A proportion of decedents are diagnosed with idiopathic myocardial fibrosis at autopsy. Recent studies have revealed myocardial fibrosis in athletes with low QRS complexes, who have survived a sudden cardiac arrest. Low QRS voltages do not feature in the electrical anomalies that warrant further investigation according to the international recommendations for electrocardiographic (ECG) interpretation in athletes, hence there is no information on the precise significance or outcome data in athletes with small QRS voltages. The investigators postulate that further evaluation of athletes with low QRS voltages using CMR and gene analysis will help determine the prevalence and significance of these ECG changes potentially identifying young vulnerable individuals at risk of SCD. There are currently 2 studies which have assessed small QRS complexes in athletes. These studies revealed 1.1-4% of Italian athletes had small QRS complexes. One study performed ultrasound of the heart showing that athletes in general had larger hearts compared to sedentary counterparts but no evidence of structural disease. The second study did not perform CMR in all athletes with small QRS complexes and only conducted CMR in 5 athletes with small QRS complexes and electrical issues and demonstrated scar in 2 athletes. The scientific basis of these studies does not prove the precise significance of small QRS complexes on the ECG in this population to elucidate the sensitivity and specificity of disease identification. It is possible that young individuals with serious cardiac abnormalities may be identified if the significance of small QRS complexes is elucidated. The prevalence of small QRS complexes in the general population is 0.3-2% but there is paucity of data on prevalence and significance on small QRS complexes in young non-athletic individuals aged 17-35 years old. This study will allow the investigators to identify the prevalence and significance of small QRS complexes in athletes and non-athletes aged 17-35 years old potentially identifying young vulnerable individuals at risk of sudden cardiac death. These results should enable informed clinical decisions (at national and international level) following pre-participation screening evaluation and help ultimately to identify young individuals and athletes who are genuinely deemed to be at risk of sudden cardiac death (SCD) whilst providing appropriate reassurance to those with normal QRS voltages. This study will also potentially aid the investigators in updating the current recommendations on ECG interpretation in athletes which will influence future international ECG recommendations in athletes.This would be a cross-sectional observational study involving 240 participants aged 17-35 years old. This will involve 4 groups; 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Athletes with low QRS voltage | – | Diagnostic Test: Cardiovascular magnetic resonance scan - 3T scanner (Siemens Vida)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) |
| Young healthy individuals (non-athletes) with low QRS voltage | – | Diagnostic Test: Cardiovascular magnetic resonance scan - 3T scanner (Siemens Vida)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) |
| Age and sex matched control group of athletes with normal QRS voltage | – | Diagnostic Test: Cardiovascular magnetic resonance scan - 3T scanner (Siemens Vida)Cohort (anticipated N = 60) will undergo testing with 12 lead ECG, blood test, cardiac MRI, 24 hour holter monitoring and cardiopulmonary exercise testing. |
| Age and sex matched young healthy controls (non-athletes) with normal QRS voltage | – | Diagnostic Test: Cardiovascular magnetic resonance scan - 3T scanner (Siemens Vida)Cohort (anticipated N = 60) will undergo testing with 12 lead ECG, blood test, cardiac MRI, 24 hour holter monitoring and cardiopulmonary exercise testing. |
Who may qualify
- Ages
- 17 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (2 listed)
- No cardiovascular symptoms
- Body mass index <30.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiovascular magnetic resonance scan - 3T scanner (Siemens Vida)Also: 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)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. | Diagnostic test | 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 |
Primary outcome
Prevalence of low QRS voltages in athletes and young non-athletic population on ECG analysis
Time frame: 36 months
Prevalence data will be obtained from existing ECG database of athletes and young people who have been screened by Cardiac risk in the young.
Prevalence of myocardial fibrosis in the young athletic and non-athletic population with low QRS
Time frame: 36 months
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)
2 secondary outcomes
The proportion of individuals with low QRS complexes and myocardial fibrosis with rare protein altering variant in a cardiomyopathy gene.
Time frame: 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
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabiha Gati, MBBS principal investigator
Royal Brompton & Harefield NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sudden Cardiac Death and Sudden Cardiac Arrest, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sabiha Gati, MBBS (07977 352296, s.gati@rbht.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of low QRS voltages in athletes and young non-athletic population on ECG analysis (time frame: 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2023.