NCT02638311已完成不适用
Using Normal Volunteer Whole Blood or Plasma Samples to Establish the 99th Percentile Upper Reference Limit (URL) for the Meritas Troponin I Test
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 769
- 试验地点
- 3
- 主要终点
- 99th percentile for Troponin results determined from whole blood and plasma in apparetly healthy volunteer population
研究概览
简要总结
Prospective multicenter sample collection and testing study.
详细描述
Prospective multicenter sample collection and testing study. Approximately 750 apparently healthy subjects, including healthy subjects with stable co-morbidities, age, gender and ethnicity dispersed will be eligible for enrollment
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female at least 21 years of age at the time of enrollment in the study.
- •Subjects with no medications or no changes in their medications in the last 3 months.
- •Subjects with and without chronic stable morbidities (i.e., renal insufficiency, hypertension, diabetes, hypercholesterolemia, pulmonary disorders, coronary disease, musculoskeletal disorders, etc.).
- •Subjects able to understand and sign the informed consent and the patient questionnaire.
排除标准
- •Subjects with a history of heart failure and/or, having received treatment for heart failure.
- •Subject with renal failure.
- •Subjects with a history of unstable heart disease or angina complaints.
- •Subjects with any change in their medication in the last 3 months (diabetics may have small variations in glucose medications but may not have unstable disease, or have suffered a diabetic crisis in the last 6 months).
- •Any known acute infection in the last 30 days.
- •Marathon runners or extreme athletes.
- •Pregnant (self-reported).
结局指标
主要结局
99th percentile for Troponin results determined from whole blood and plasma in apparetly healthy volunteer population
时间窗: 1 day
次要结局
未报告次要终点
研究者
研究点 (3)
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