NCT07735338尚未招募不适用
Prospective Study of the Diagnostic Accuracy of a Smartphone Application to PREDICT Real-Time Cardiovascular Risk for Heart Attack and Stroke (PREDICT-HS)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Number of ASCVD events
研究概览
简要总结
To assess the diagnostic accuracy of a smartphone application in predicting heart attack or stroke within 3-4 days in high-risk patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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:
- •i) 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.
- •ii) Coronary artery calcium score ≥ 100 Agatston units.
- •iii) High estimated10-year ASCVD risk ≥ 20% by pooled cohort equation.
- •iv) 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
- •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 m
- •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
- •i. Diabetes
排除标准
- •The 10-year ASCVD risk <7.5%.
- •Elevated troponin at baseline.
- •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.
- •Pregnant women or women of childbearing potential not using contraception.
- •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.
- •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
结局指标
主要结局
Number of ASCVD events
时间窗: Baseline through 18 months
ASCVD events include myocardial infarction (MI), ischemic stroke/transient ischemic attack (TIA), CV death, or clinically driven arterial revascularization or hospitalization.
次要结局
未报告次要终点
研究者
Sandra Anping Tsai
Clinical Associate Professor in Medicine
Stanford University
研究点 (1)
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