Cardiovascular Screening in Asymptomatic South Asians

January 8, 2025 updated by: Vinoda Sharma, Sandwell & West Birmingham Hospitals NHS Trust

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).

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)
  • hyperlipidaemia
  • family history of premature coronary artery disease (male <45 years, female <55 years)
  • smoking (current or ex-smoker in the last 3 months)

Exclusion Criteria:

  • 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
    • Active ongoing malignancy and treatment for the same
    • eGFR ≤30ml/min/1.72m2
    • Participation in any other interventional research trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Q risk 3 score
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
Experimental: screening CTCA
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association of Q risk 3 score with plaque seen on CTCA
Time Frame: through study completion, an average of 1 year
To assess the association of Q-risk 3 score with plaque on CTCA by receiver operating curve
through study completion, an average of 1 year
Predictors of plaque on CTCA
Time Frame: through study completion, an average of 1 year
To assess the predictors of plaque on CTCA by Cox proportional hazard analysis
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sandwell & West Birmingham Hospitals NHS Trust

Investigators

  • Study Chair: Vinoda Sharma, FRCP FESC, Sandwell & West Birmingham Hospitals NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 31, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

July 31, 2027

Study Registration Dates

First Submitted

December 19, 2024

First Submitted That Met QC Criteria

January 3, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 8, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRAS Project ID: 331211

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This is a pilot study which will help to conduct larger studies which will confirm or refute the pilot study findings

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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