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Cardiovascular Screening in Asymptomatic South Asians

NCT06765785 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-01-10

No results posted yet for this study

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.

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.

Conditions

  • Cardiovascular Diseases
  • Asymptomatic Condition
  • South Asian

Interventions

DIAGNOSTIC_TEST

CTCA

Screening CTCA will be performed in the experimental arm after 1:1 randomisation using sealed envelope technique

Sponsors & Collaborators

  • Sandwell & West Birmingham Hospitals NHS Trust

    lead OTHER

Principal Investigators

  • Vinoda Sharma, FRCP FESC · Sandwell & West Birmingham Hospitals NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-31
Primary Completion
2026-12-31
Completion
2027-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06765785 on ClinicalTrials.gov