Health Condition 1: I70-I79- Diseases of arteries, arterioles and capillaries
Conditions
Interventions
Intervention1: Nil: Nil
Control Intervention1: Nil: Nil
Sponsors
Sun Pharma Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Correlation between Coronary Artery Calcium score and 10-year Atherosclerotic Cardiovascular Disease risk score in Indian individuals asymptomatic for Coronary Artery DiseaseTimepoint: Visit 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.Timepoint: 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.Timepoint: 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.Timepoint: Visit 1;Atherosclerotic Cardiovascular Disease risk assessment on the basis of polygenic risk scores.Timepoint: 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.Timepoint: Visit 1;Drug utilization pattern in the study participants.Timepoint: Visit 1 | — |
Countries
India
Contacts
Public ContactMs Colette Pinto
Sun Pharma Laboratories Limited
Outcome results
None listed