Abbott Stress-Delta Biomarkers for ACS Risk Stratification
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- % Post Stress-Delta
研究概览
简要总结
Acute Coronary Syndrome (ACS) is a serious heart condition that is a leading cause of death in America. Cardiac stress testing is currently the best test to non-invasively identify which patients might be having ACS and may need more invasive testing such as a cardiac catheterization (placing a tube in the heart) for coronary angiogram (invasive mapping of the blood vessels of the heart). However, stress tests require imaging by highly trained specialists and even then may not correctly categorize a small minority of patients being evaluated for ACS.
Advances in blood tests may now allow detection of the very early stages of heart blood vessel blockage via a simple blood test. The investigators seek to determine whether these blood tests can help to better identify patients with ACS. The study will also store any extra blood sample that may be left over for future use.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient presenting to the ED with clinical suspicion of ACS as determined by the treating emergency physician. These include symptoms including but not limited to chest pain, pressure, or burning sensation across the precordium.
- •Age 40 years or older.
- •As part of their usual clinical care, the subject is scheduled to have a cardiac stress test. This includes nuclear (adenosine, regadenosine, or other adjunct with SPECT), either pharmacologic (dobutamine) or exercise (treadmill) echocardiography, or cardiac magnetic resonance imaging. Prior cardiac testing or observation unit evaluation is not an exclusion criterion.
排除标准
- •Patient with cardiac marker diagnosis of acute myocardial infarction or who otherwise is not a candidate for a cardiac stress test.
- •Evidence of serious arrhythmias or acute MI or ischemia on ECG
- •Unstable vital signs: persistent (> 2 readings or over 2 hours) hypotension (systolic blood pressure < 80 mm Hg), pulse > 110 beats per minute.
- •Any medical condition that would be worsened by cardiac stress
- •Aortic aneurysm or dissection
- •Active myocarditis or pericarditis
- •Ventricular dysrhythmia or significant atrial dysrhythmia
- •Severe or greater degree of aortic stenosis
- •Acute or decompensated heart failure or pulmonary edema
- •Pulmonary embolism
- •Aortic aneurysm
- •Patient is non-English speaking.
- •Patient is incarcerated or a prisoner.
- •Patient does not have capacity to consent.
结局指标
主要结局
% Post Stress-Delta
时间窗: 1 hour
1-hour Post-Stress Troponin I - Resting Baseline Troponin I)/ Resting Baseline Troponin I
% 2-hour Stress-Delta
时间窗: 2 hour
(3-hour Post-Stress Troponin I - Resting Baseline Troponin I)/ Resting Baseline Troponin I
次要结局
- Delta BNP values(2hr)