Coronary Artery Calcium Scoring in Asymptomatic Indian population: Correlation with ASCVD risk scores, Age, Gender and other risk factors.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 404
- 试验地点
- 8
- 主要终点
- Correlation between Coronary Artery Calcium score and 10-year Atherosclerotic Cardiovascular Disease risk score in Indian individuals asymptomatic for Coronary Artery Disease
研究概览
简要总结
Cardiovascular Diseases (ischemic heart disease and cerebrovascular disease conditions), are the leading cause of death worldwide. Atherosclerosis plays a central role, with early fatty streaks progressing to late complex atheromas. Vascular calcification has been shown to strongly correlate with degree of atherosclerosis.
Over the last several decades, the global prevalence and mortality of atherosclerotic cardiovascular disease (ASCVD) has increased. Identifying risk factors associated with ASCVD have been paramount to informing public health policies and interventions to reduce ASCVD risk. Assessing ASCVD risk based on CVD risk factors, including hypercholesterolemia, hypertension, tobacco use, and physical inactivity helps guide treatment, primarily aimed at reducing low-density lipoprotein-cholesterol (LDL-C) in primary prevention, as cumulative exposure to LDL-C is the main driver for ASCVD.
The ASCVD risk score, developed by the American College of Cardiology, is a calculation of person’s 10-year risk of developing a cardiovascular event, such as a heart attack or stroke. This risk estimate considers age, gender, race, cholesterol levels, blood pressure, medication use, diabetic status, and smoking status. However, ASCVD risk score is not validated for Indian population.
Coronary Artery Calcium (CAC) scoring has emerged as a widely available tool for stratifying cardiovascular risk, predicting patient outcomes, and guiding therapy.CAC is a highly specific marker for coronary atherosclerosis.
For the cardiovascular risk identification, different markers and clinical investigations are available. In this study, the participant will be stratified into different cardiovascular risk category based on different clinical risk estimation parameters and methods. Overall, this study will help in identifying ASCVD risk levels of the individuals and correlate risk levels in appropriate cardiac risk category who are asymptomatic for coronary artery disease.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 40.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Male of age between 40 to 65 years (both inclusive) or non-pregnant/non-lactating female of age between 40 to 70 years (both inclusive).
- •Participant with history or evidence of at least one of ASCVD risk factors such as hypertension (BP greater than or equal to 140/90 mmHg), diabetes mellitus (random plasma glucose greater than or equal to 200 mg/dl or fasting plasma glucose greater than or equal to 126 mg/dl or HbA1c greater than or equal to 6.5 percent), dyslipidemia (Cholesterol greater than or equal to 200 mg/dl or LDL-C greater than or equal to 130 mg/dl or HDL-C less than 40 mg/dl in men and less than 50 mg/dl in women or triglyceride greater than or equal to 150 mg/dl), a family history of premature CAD (having a primary relative who had been diagnosed with CAD prior to the age of 55 years in a male relative or 65 years in a female relative), or cigarette smoking (greater than or equal to 20 pack-years).
- •Participant willing to provide informed consent and comply with study procedures.
排除标准
- •Participant with CAD symptoms (chest discomfort, dyspnoea, palpitations, syncope or fatigue).
- •Participant with previous coronary revascularization i.e. CABG and/or angioplasty.
- •Participant with previous imaging (Angiography, CT angiogram, MR angiogram) showing CAD.
- •Participant with history of positive stress test.
结局指标
主要结局
Correlation between Coronary Artery Calcium score and 10-year Atherosclerotic Cardiovascular Disease risk score in Indian individuals asymptomatic for Coronary Artery Disease
时间窗: Visit 1
次要结局
- Correlation between Coronary Artery Calcium score and Lipoprotein (a) Lp(a) values, high-sensitivity C-reactive protein (hsCRP), Urine albumin to creatinine ratio (ACR), estimated glomerular filtration rate (eGFR) and ultrasound sonography carotid plaques.(Visit 1)
- Correlation between 10-year Atherosclerotic Cardiovascular Disease risk score and Lipoprotein (a) values, high-sensitivity C-Reactive Protein, Urine albumin to creatinine ratio (ACR), estimated glomerular filtration rate (eGFR), ultrasound sonography carotid plaques.(Visit 1)
- Net reclassification of patients with 10-year Atherosclerotic Cardiovascular Disease risk score between 5 to 10 depending upon Coronary Artery Calcium score and ultrasound sonography carotid plaques.(Visit 1)
- Atherosclerotic Cardiovascular Disease risk assessment on the basis of polygenic risk scores.(Visit 1)
- Effect of different risk factors such as age, hypertension, diabetes mellitus, dyslipidemia, family history of premature Coronary Artery Disease and cigarette smoking on Coronary Artery Calcium score.(Visit 1)
- Drug utilization pattern in the study participants.(Visit 1)
研究者
Dr Chintan Khandhedia
Sun Pharma Laboratories Limited