Cardiovascular Screening in Asymptomatic South Asians

NCT06765785 | Not Yet Recruiting

• 1 other identifier: IRAS Project ID: 331211
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

South Asian

Outcome Measures

Primary Outcomes (1)

• Patients treated by primary prevention

  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 Outcomes (2)

• Association of Q risk 3 score with plaque seen on CTCA

  through study completion, an average of 1 year

• Predictors of plaque on CTCA

  through study completion, an average of 1 year

Study Arms (2)

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

Diagnostic Test: CTCA

Interventions

CTCA DIAGNOSTIC_TEST

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

screening CTCA

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sandwell & West Birmingham Hospitals NHS Trust: lead

Related Publications (4)

• 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.

  PMID: 16439223 BACKGROUND

• Hughes 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.

  PMID: 37966910 BACKGROUND

• Hippisley-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.

  PMID: 28536104 BACKGROUND

• Harding S. Mortality of migrants from the Indian subcontinent to England and Wales: effect of duration of residence. Epidemiology. 2003 May;14(3):287-92.

  PMID: 12859028 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Asymptomatic Diseases

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Vinoda Sharma, FRCP FESC

  Sandwell & West Birmingham Hospitals NHS Trust

  STUDY CHAIR

Central Study Contacts

Vinoda Dr Sharma, FRCP FESC

CONTACT

+441215075841; vinodasharma@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Cardiologist

Model Details: Pilot randomised study with patients being allocated 1:1 to either Q-risk 3 score or screening CTCA

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: January 9, 2025
• Study Start: December 31, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: January 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share