Smartphone Application to PREDICT Real-Time Cardiovascular Risk for Heart Attack and Stroke

Más betegség

• Cognitive impairment.
• Neurological disorders that would impair their ability to provide informed consent or adhere to study protocols.
• Metastatic cancer or active cancer undergoing chemotherapy.
• Terminal illness.
• Current or past major psychiatric disorders (e.g., schizophrenia, bipolar disorder, severe depression) that could affect physiological or biometric data.
• Surgical or medical condition, which in the opinion of the Investigator, may place the participant at higher risk from his/her participation in the study, or is likely to prevent the participant from complying with the requirements of the study or completing the study.

Egyéb

• The 10-year ASCVD risk <7.5%.
• Elevated troponin at baseline.
• Pregnant women or women of childbearing potential not using contraception.
• Unwillingness or inability to comply with study procedures, including adherence to study visits, fasting blood draws and compliance with study protocol.
• Residing in an inpatient facility or bedbound

• Be able to provide electronic or written informed consent and be able to effectively communicate and understand the study procedures, risks, and required activities.
• Age 40 to 79 years.
• Be willing to wear a smartwatch continuously for 18 months and comfortable with using wearable devices or other technologies that monitor their data over time.
• Established ASCVD or at an increased risk for a first MACE (i.e., no prior major ASCVD event), defined as anyone of the following:
• Evidence of atherosclerotic CAD on CT or invasive coronary angiogram defined as a coronary artery stenosis ≥ 20% but <50% in the left main coronary artery or a stenosis ≥ 20% but <70% in any other major coronary artery.
• Coronary artery calcium score ≥ 100 Agatston units.
• High estimated10-year ASCVD risk ≥ 20% by pooled cohort equation.
• Intermediate estimated 10-year ASCVD risk 7.5% to <20% by pooled cohort equation with at least 2 of the following risk-enhancing factors:
• A first degree relative with history of premature ASCVD (males, age <55 years; females, age <65 years).
• History of premature menopause before age 40.
• History of maternal pregnancy complications (defined as a history of either preeclampsia, gestational hypertension, or gestational diabetes).
• South Asian ancestry.
• Chronic inflammatory disorders (defined as either rheumatoid arthritis, systemic lupus erythematosus, psoriasis covering ≥10% of body surface area, Crohn's disease, ulcerative colitis, or HIV/AIDS).
• High-sensitivity C-reactive protein (hsCRP) ≥2 mg/L documented in the 12 months preceding the screening visit, and, in absence of any underlying acute or inflammatory conditions.
• Lipoprotein (a) ≥50 mg/dL or ≥125 nmol/L at any time before the screening visit.
• Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2.
• Ankle branchial index (ABI) <0.9 with no symptoms of intermittent claudication.
• Metabolic syndrome: increased waist circumference, elevated triglycerides, elevated blood pressure, elevated glucose, and low HDL-C are factors
• Diabetes