Cardiovascular DiseasesNCT06765785
Cardiovascular Screening in Asymptomatic South Asians
A study testing CTCA in people with Cardiovascular Diseases and Asymptomatic Condition, run by Sandwell & West Birmingham Hospitals NHS Trust.
Trial summary
Cardiovascular disease (CVD) is the leading cause of morbidity, mortality and healthcare costs in the United Kingdom. Ethnic minorities like South Asians (SA) have a 3-5 times higher incidence of CVD as predicted by various risk scores despite similar or fewer traditional cardiovascular risk factors. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Cardiovascular Diseases, Asymptomatic Condition, South Asian
- What is being tested?
- CTCA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2024to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Asymptomatic South Asian patients of age
- men≥30 years ≤60 years
- Women >50 years ≤60 years
- Plus at least one of the following risk factors:
- hypertension (HTN)
- diabetes mellitus (DM)
Show all 9Show fewer
- hyperlipidaemia
- family history of premature coronary artery disease (male <45 years, female <55 years)
- smoking (current or ex-smoker in the last 3 months)
Who cannot join
- Patients meeting any of the following criteria will be excluded
- Patients unable to give written informed consent
- History of previous coronary events/CABG/ coronary stenting or CTCA in the last 4 years
- Patients with pre-existing cardiac symptoms
- Patients who could or are pregnant
- Allergy to iodine contrast
Show all 9Show fewer
- Active ongoing malignancy and treatment for the same
- eGFR ≤30ml/min/1.72m2
- Participation in any other interventional research trial
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Cardiovascular Screening in Asymptomatic South Asians - a Pilot Randomized Comparison of Q-risk 3 Score Versus Computed Tomography Coronary Angiography (CTCA)
Cardiovascular disease (CVD) is the leading cause of morbidity, mortality and healthcare costs in the United Kingdom. Ethnic minorities like South Asians (SA) have a 3-5 times higher incidence of CVD as predicted by various risk scores despite similar or fewer traditional cardiovascular risk factors.
Computed Tomography Coronary Angiography (CTCA) is able to outline the coronary anatomy determining the site, severity and type of atherosclerotic plaque location in the heart arteries. The National Institute for Health and Care Excellence (NICE) guidelines recommends CTCA as the first line investigation for stable chest pain considered to be coming from the heart (angina).
Read more
However there is no pathway for the patients who are asymptomatic but at high risk of CVD, such as the SA cohort. Current practice involves using risk scores to guide management of asymptomatic adults. One recommended and commonly used score is the Q-risk score (the QRISK ® 3-2018 risk calculatorhttps://qrisk.org > three). This score incorporates ethnicity amongst other risk factors and patients with a risk ≥10% of having a heart attack or stroke in the next 10 years are offered primary prevention treatment with low dose statin therapy. For example, an average (height 164cm weight 70kg) 40 year old male of SA descent, without symptoms who is a non-smoker but with Diabetes Mellitus (DM) on tablet treatment scores 5.8% - this risk is not high enough to warrant treatment with a statin unless he also has abnormally raised cholesterol levels. But this patient is still high risk of CVD due to his ethnicity and DM. There is no current evidence to tailor treatment in such asymptomatic, high risk ethnic minorities.
Similar to screening programs for cancer, screening CTCA, compared to risk stratification with the QRISK ® 3 score, may help in risk stratification of a higher proportion of SA patients. 50 asymptomatic SA patients from 2 sites (25 patients each site) with one CV risk factor will be randomised to either Q-risk 3 score or to screening CTCA.
Read the detailed description
This is a pilot study- 50 patients, randomised 1:1 to each arm (25 patients per arm). This is 10% of the original sample size of 500. As this is a 2 centre study, each centre will recruit 25 patients and the financial requirement will be the responsibility of the individual centre.
Potential participants will be recruited from specialist non-Cardiology clinics in Sandwell and West Birmingham Hospitals (SWBH) NHS Trust and the Barts London hospital. Participants will be approached by members of the clinical care team when they attend the specialist non-Cardiology clinic. This study will be discussed with the participants and the patient information sheet handed over to them. Assent will be taken for further review in clinic by a member of the research team. Following this and written informed consent, they will be randomised to either CTCA or Q-risk 3 score.
Non-English-speaking patients will have a Trust translator (either language line or in-person).
Randomisation: Block randomisation with sealed envelope technique after written informed consent. Randomisation will be performed by members of the research team. Patients will randomised 1:1 to the interventional arm (CTCA) or Q-risk 3 score.
Blood tests: After consent, a routine blood sample of 20 millilitres (ml) - will be collected. The blood sample will be analysed at sites local lab and the following results will be collected: full blood count, urea and electrolytes, glycosylated haemoglobin (HbA1c), lipid profile and lipoprotein a (Lp (a) ).
Follow up: At one year from recruitment, patients will have a telephonic follow up to obtain information regarding occurrence of any events and/or hospitalisation.
Data collection, management and analysis:
- Electronic case record file (eCRF) and online database to collect demographic, medical history, CTCA report and Q risk score information.
- Blood samples in both groups
- Comparison of demographics, bloods, proportion started on primary prevention treatment between the CTCA and Q-risk 3 group.
- Categorical variables will be presented as percentage and compared with the chi square or Fisher's test.
- Continuous variables will be presented as mean (+/- standard deviation) and tested for normalcy by
- Kolmogorov-Smirnov test. Normal variables will be compared by student's t-test or in the case or non-normal variables by Analysis of Variance (ANOVA).
- Proportion of patients in the CTCA arm who receive primary prevention treatment versus proportion in the Q-risk arm who receive primary prevention treatment will be compared, as will the composite of event rates and hospital admissions at one year.
- In addition, the association of Q-risk 3 score with plaque on CTCA will be analysed by ROC curve.
Confidentiality: No identifiable data will be leaving the Trust. The respective sites (SWBH and Barts hospitals) will individually perform the CTCA and Q-risk 3 score on their cohort of patients and report it individually Authorised members of the Sponsor organisation will monitor the research at appropriate timelines and therefore have access to patients' identifiable information. Patients recruited will be allocated a participant ID.
Pseudonymised data will be collected on electronic case report forms (CRFs). Following completion of the study, anonymised data will be analysed. NHS indemnity will apply to this study. Study data will be stored for a maximum of 5 years after closure.
Ethics: All required ethical approval(s) for the trial will be sought using the Integrated Research Application System. The trial will be conducted in accordance with all relevant regulations.
Before enrolling patients into the trial, each trial site must ensure that the local conduct of the trial has the agreement of the relevant NHS Trust Research \& Development (R\&D) department. Sites will not be permitted to enrol patients into the trial until written confirmation of Capacity and Capability (CC\&C) is received. All patients will be consented prior to inclusion in this study.
- Conditions
- Cardiovascular Diseases, Asymptomatic Condition, South Asian
- Being tested
- CTCA
- Keywords
- South Asian
- Medical subject headings
- Cardiovascular Diseases, Asymptomatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTCADiagnostic test
Screening CTCA will be performed in the experimental arm after 1:1 randomisation using sealed envelope technique
| Study group | Role | What they receive |
|---|---|---|
| Q risk 3 score | No intervention | Q risk 3 score will be calculated and if the 10 year risk of cardiovascular events is >/=10%, patients in this arm will receive primary prevention treatment |
| screening CTCA | Experimental | Patients randomised to the CTCA arm will receive primary prevention treatment if plaque is present on the CTCA Receives: Diagnostic Test: CTCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients treated by primary prevention
To compare the proportion of patients treated by primary prevention therapy with screening CTCA versus Q-risk 3 score
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Association of Q risk 3 score with plaque seen on CTCA
To assess the association of Q-risk 3 score with plaque on CTCA by receiver operating curve
Measured: through study completion, an average of 1 year
Predictors of plaque on CTCA
To assess the predictors of plaque on CTCA by Cox proportional hazard analysis
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start31 Dec 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot randomised study with patients being allocated 1:1 to either Q-risk 3 score or screening CTCA
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sandwell & West Birmingham Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vinoda Sharma, Sandwell & West Birmingham Hospitals NHS Trust
- Investigators
- Vinoda Sharma, FRCP FESC, Study chair, Sandwell & West Birmingham Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06765785
- Sponsor's protocol ID
- IRAS Project ID: 331211
- Status last verified
- Jan 2025
- First submitted
- 19 Dec 2024
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a pilot study which will help to conduct larger studies which will confirm or refute the pilot study findings
Publications
Lim MC, Wong TW, Yaneza LO, De Larrazabal C, Lau JK, Boey HK. Non-invasive detection of significant coronary artery disease with multi-section computed tomography angiography in patients with suspected coronary artery disease. Clin Radiol. 2006 Feb;61(2):174-80. doi: 10.1016/j.crad.2005.09.006.
PubMed 16439223Hughes DM, Coronado JIC, Schofield P, Yiu ZZN, Zhao SS. The predictive accuracy of cardiovascular disease risk prediction tools in inflammatory arthritis and psoriasis: an observational validation study using the Clinical Practice Research Datalink. Rheumatology (Oxford). 2024 Dec 1;63(12):3432-3441. doi: 10.1093/rheumatology/kead610.
PubMed 37966910Hippisley-Cox J, Coupland C, Brindle P. Development and validation of QRISK3 risk prediction algorithms to estimate future risk of cardiovascular disease: prospective cohort study. BMJ. 2017 May 23;357:j2099. doi: 10.1136/bmj.j2099.
PubMed 28536104Harding S. Mortality of migrants from the Indian subcontinent to England and Wales: effect of duration of residence. Epidemiology. 2003 May;14(3):287-92.
PubMed 12859028
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Screening in Asymptomatic South Asians - a Pilot Randomized Comparison of Q-risk 3 Score Versus Computed Tomography Coronary Angiography (CTCA)
- ClinicalTrials.gov ID
- NCT06765785
- Acronym / sponsor ID
- IRAS Project ID: 331211
- Conditions
- Cardiovascular Diseases, Asymptomatic Condition, South Asian
- Keywords
- South Asian
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sandwell & West Birmingham Hospitals NHS TrustUniversity, hospital or other
- Study start
- 31 Dec 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 9 Jan 2025 (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.
Cardiovascular disease (CVD) is the leading cause of morbidity, mortality and healthcare costs in the United Kingdom. Ethnic minorities like South Asians (SA) have a 3-5 times higher incidence of CVD as predicted by various risk scores despite similar or fewer traditional cardiovascular risk factors.
Computed Tomography Coronary Angiography (CTCA) is able to outline the coronary anatomy determining the site, severity and type of atherosclerotic plaque location in the heart arteries. The National Institute for Health and Care Excellence (NICE) guidelines recommends CTCA as the first line investigation for stable chest pain considered to be coming from the heart (angina).
However there is no pathway for the patients who are asymptomatic but at high risk of CVD, such as the SA cohort. Current practice involves using risk scores to guide management of asymptomatic adults. One recommended and commonly used score is the Q-risk score (the QRISK ® 3-2018 risk calculatorhttps://qrisk.org > three). This score incorporates ethnicity amongst other risk factors and patients with a risk ≥10% of having a heart attack or stroke in the next 10 years are offered primary prevention treatment with low dose statin therapy. For example, an average (height 164cm weight 70kg) 40 year old male of SA descent, without symptoms who is a non-smoker but with Diabetes Mellitus (DM) on tablet treatment scores 5.8% - this risk is not high enough to warrant treatment with a statin unless he also has abnormally raised cholesterol levels. But this patient is still high risk of CVD due to his ethnicity and DM. There is no current evidence to tailor treatment in such asymptomatic, high risk ethnic minorities.
Similar to screening programs for cancer, screening CTCA, compared to risk stratification with the QRISK ® 3 score, may help in risk stratification of a higher proportion of SA patients. 50 asymptomatic SA patients from 2 sites (25 patients each site) with one CV risk factor will be randomised to either Q-risk 3 score or to screening CTCA.
Detailed description
This is a pilot study- 50 patients, randomised 1:1 to each arm (25 patients per arm). This is 10% of the original sample size of 500. As this is a 2 centre study, each centre will recruit 25 patients and the financial requirement will be the responsibility of the individual centre.
Potential participants will be recruited from specialist non-Cardiology clinics in Sandwell and West Birmingham Hospitals (SWBH) NHS Trust and the Barts London hospital. Participants will be approached by members of the clinical care team when they attend the specialist non-Cardiology clinic. This study will be discussed with the participants and the patient information sheet handed over to them. Assent will be taken for further review in clinic by a member of the research team. Following this and written informed consent, they will be randomised to either CTCA or Q-risk 3 score.
Non-English-speaking patients will have a Trust translator (either language line or in-person).
Randomisation: Block randomisation with sealed envelope technique after written informed consent. Randomisation will be performed by members of the research team. Patients will randomised 1:1 to the interventional arm (CTCA) or Q-risk 3 score.
Blood tests: After consent, a routine blood sample of 20 millilitres (ml) - will be collected. The blood sample will be analysed at sites local lab and the following results will be collected: full blood count, urea and electrolytes, glycosylated haemoglobin (HbA1c), lipid profile and lipoprotein a (Lp (a) ).
Follow up: At one year from recruitment, patients will have a telephonic follow up to obtain information regarding occurrence of any events and/or hospitalisation.
Data collection, management and analysis:
- Electronic case record file (eCRF) and online database to collect demographic, medical history, CTCA report and Q risk score information.
- Blood samples in both groups
- Comparison of demographics, bloods, proportion started on primary prevention treatment between the CTCA and Q-risk 3 group.
- Categorical variables will be presented as percentage and compared with the chi square or Fisher's test.
- Continuous variables will be presented as mean (+/- standard deviation) and tested for normalcy by
- Kolmogorov-Smirnov test. Normal variables will be compared by student's t-test or in the case or non-normal variables by Analysis of Variance (ANOVA).
- Proportion of patients in the CTCA arm who receive primary prevention treatment versus proportion in the Q-risk arm who receive primary prevention treatment will be compared, as will the composite of event rates and hospital admissions at one year.
- In addition, the association of Q-risk 3 score with plaque on CTCA will be analysed by ROC curve.
Confidentiality: No identifiable data will be leaving the Trust. The respective sites (SWBH and Barts hospitals) will individually perform the CTCA and Q-risk 3 score on their cohort of patients and report it individually Authorised members of the Sponsor organisation will monitor the research at appropriate timelines and therefore have access to patients' identifiable information. Patients recruited will be allocated a participant ID.
Pseudonymised data will be collected on electronic case report forms (CRFs). Following completion of the study, anonymised data will be analysed. NHS indemnity will apply to this study. Study data will be stored for a maximum of 5 years after closure.
Ethics: All required ethical approval(s) for the trial will be sought using the Integrated Research Application System. The trial will be conducted in accordance with all relevant regulations.
Before enrolling patients into the trial, each trial site must ensure that the local conduct of the trial has the agreement of the relevant NHS Trust Research \& Development (R\&D) department. Sites will not be permitted to enrol patients into the trial until written confirmation of Capacity and Capability (CC\&C) is received. All patients will be consented prior to inclusion in this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot randomised study with patients being allocated 1:1 to either Q-risk 3 score or screening CTCA
| Arm | Type | Receives |
|---|---|---|
| Q risk 3 score | No intervention | –Q risk 3 score will be calculated and if the 10 year risk of cardiovascular events is >/=10%, patients in this arm will receive primary prevention treatment |
| screening CTCA | Experimental | Diagnostic Test: CTCAPatients randomised to the CTCA arm will receive primary prevention treatment if plaque is present on the CTCA |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Asymptomatic South Asian patients of age
- hypertension (HTN)
- diabetes mellitus (DM)
- hyperlipidaemia
- family history of premature coronary artery disease (male <45 years, female <55 years)
Key exclusion criteria (9 listed)
- Patients meeting any of the following criteria will be excluded
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 |
|---|---|---|
| CTCAScreening CTCA will be performed in the experimental arm after 1:1 randomisation using sealed envelope technique | Diagnostic test | screening CTCA |
Primary outcome
Patients treated by primary prevention
Time frame: through study completion, an average of 1 year
To compare the proportion of patients treated by primary prevention therapy with screening CTCA versus Q-risk 3 score
2 secondary outcomes
Association of Q risk 3 score with plaque seen on CTCA
Time frame: through study completion, an average of 1 year
Predictors of plaque on CTCA
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Background: PubMed 16439223Lim MC, Wong TW, Yaneza LO, De Larrazabal C, Lau JK, Boey HK. Non-invasive detection of significant coronary artery disease with multi-section computed tomography angiography in patients with suspected coronary artery disease. Clin Radiol. 2006 Feb;61(2):174-80. doi: 10.1016/j.crad.2005.09.006.
- Background: PubMed 37966910Hughes DM, Coronado JIC, Schofield P, Yiu ZZN, Zhao SS. The predictive accuracy of cardiovascular disease risk prediction tools in inflammatory arthritis and psoriasis: an observational validation study using the Clinical Practice Research Datalink. Rheumatology (Oxford). 2024 Dec 1;63(12):3432-3441. doi: 10.1093/rheumatology/kead610.
- Background: PubMed 28536104Hippisley-Cox J, Coupland C, Brindle P. Development and validation of QRISK3 risk prediction algorithms to estimate future risk of cardiovascular disease: prospective cohort study. BMJ. 2017 May 23;357:j2099. doi: 10.1136/bmj.j2099.
- Background: PubMed 12859028Harding S. Mortality of migrants from the Indian subcontinent to England and Wales: effect of duration of residence. Epidemiology. 2003 May;14(3):287-92.
- Individual participant dataSharing planned: No. This is a pilot study which will help to conduct larger studies which will confirm or refute the pilot study findings
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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.
Vinoda Sharma, FRCP FESC study chair
Sandwell & West Birmingham Hospitals NHS Trust
Questions about this trial
What is this clinical trial studying?
A study testing CTCA in people with Cardiovascular Diseases and Asymptomatic Condition, run by Sandwell & West Birmingham Hospitals NHS Trust.
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 9 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: opening soon, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vinoda Dr Sharma, FRCP FESC (+441215075841, vinodasharma@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients treated by primary prevention (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06765785, which also lists 4 linked publications.
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 10 Jan 2025.