Cardiovascular Screening in Asymptomatic South Asians - a Pilot Randomized Comparison of Q-risk 3 Score Versus Computed Tomography Coronary Angiography (CTCA)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Patients treated by primary prevention
研究概览
简要总结
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.
详细描述
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) ).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Patients treated by primary prevention
时间窗: 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
次要结局
- 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)
研究者
Vinoda Sharma
Consultant Cardiologist
Sandwell & West Birmingham Hospitals NHS Trust