An interventional study of CTCA in Cardiovascular Diseases, Asymptomatic Condition and South Asian, sponsored by Sandwell & West Birmingham Hospitals NHS Trust. Not yet recruiting. Open to participants aged 30 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-01-10.
Sponsored by Sandwell & West Birmingham Hospitals NHS Trust · Not applicable, Interventional, and Prevention
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.
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:
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.
5,368 studies on the registry are indexed under Cardiovascular Diseases; 939 are open to participants now.
This study's planned enrollment of 50 is below the median of 100 across 3,084 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Sandwell & West Birmingham Hospitals NHS Trust is the lead sponsor of 16 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Asymptomatic South Asian patients of age
Plus at least one of the following risk factors:
Exclusion Criteria:
Patients meeting any of the following criteria will be excluded
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Patients randomised to the CTCA arm will receive primary prevention treatment if plaque is present on the CTCA
Diagnostic Test: CTCA
Screening CTCA will be performed in the experimental arm after 1:1 randomisation using sealed envelope technique
Patients treated by primary prevention
To compare the proportion of patients treated by primary prevention therapy with screening CTCA versus Q-risk 3 score
Time frame: through study completion, an average of 1 year
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
Time frame: 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
Time frame: through study completion, an average of 1 year
No study locations are listed for this record.
Plan to share: No — This is a pilot study which will help to conduct larger studies which will confirm or refute the pilot study findings
Start is estimated for Dec 2024; primary completion for Dec 2026, 24 months later.
Of 1,077 non-industry interventional studies with no phase under Cardiovascular Diseases, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 24 months is close to that.
Counting every sponsor, half of 1,216 studies reached it within 26 months; a quarter within 12 and three quarters within 49.
Cardiovascular Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Sandwell & West Birmingham Hospitals NHS Trust