Cardiology-Emergency Medicine Cardiac Biomarker Research Initiative
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 575
- 试验地点
- 1
- 主要终点
- Study Objective
研究概览
简要总结
This is an OBSERVATIONAL Specimen procurement and data collections trial for acute coronary syndrome that will be conducted in the Emergency Department at Henry Ford Hospital.
The standard protocol for evaluating patients in the Emergency Department for possible acute myocardial infarction includes the measurement of cardiac troponin over 3 hours. Subjects presenting to the ED with chest discomfort or ischemic symptoms will be eligible for blood draw protocol. The study is blinded to treating physicians and does not change current standard of care. After informed consent patients will have blood samples drawn at 0, 30 minutes, 1 hour and 3 hours.
Serum from the samples will be stored in a -80 research freezer to be evaluated at a later time as new cardiac markers for acute coronary syndrome are developed.
详细描述
Subjects considered for enrollment in this study will be identified and approached by either the Principal Investigator or trained study coordinator (SC). Candidates for enrollment will be individuals presenting with signs and/or symptoms of Acute Coronary Syndrome at the Henry Ford Hospital Emergency Department (ED).
This specimen collection study is a prospective serial draw plasma collection study designed to collect specimens for use in existing or future clinical studies. Specimen collection is expected to take approximately 30-36 months. Specimens will be collected from subjects that are being evaluated for Acute Coronary Syndrome (ACS).
Other than sample collection, no special procedures or medications are required by the study.
The study aims to enroll approximately 250-500 individuals evaluated for possible ACS in the ED.
Specimens will be obtained from the subject at the following time points:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient greater than 21 years of age
- •Experiencing symptoms of possible ACS
- •Willing and able to comply with all aspect of the protocol
排除标准
- •Acute distress and/or requires immediate life-saving intervention
- •CPR, external defibrillation or cardioversion within 24 hours of presentation
- •Unable to provide or understand the informed consent
- •STEMI leading to immediate reperfusion
- •Transferred from another facility
- •Trauma related injuries
- •Pregnancy or breast feeding
结局指标
主要结局
Study Objective
时间窗: 4 years
The study objective is to collect blood and plasma specimens for the assessment of ACS Biologic Assessments in patients presenting to the Emergency Department with symptoms consistent with ACS according to Henry Ford Medical Group current system guidelines.
次要结局
- ACS Marker Evaluation(5 years)
研究者
Richard M Nowak
Principal Investigator
Henry Ford Health System