Stress Testing Versus Non-Stress Testing Based Strategy in Patients Hospitalized With Low-Risk Acute Coronary Syndromes: A Randomized, Single-Center Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Composite of all-cause mortality, hospitalization for UA/NSTEMI or STEMI, and urgent revascularization
研究概览
简要总结
A large number of patients are diagnosed with low risk ACS, and these individuals are at significant cardiovascular risk. Though guidelines recommend stress testing to manage low risk ACS patients, evidence supporting this recommendation is not based on trials examining this population. A well-designed, randomized trial is warranted to determine if stress testing is useful in managing low risk ACS. If medical therapy alone is equivalent as the investigators hypothesize, healthcare expenditures could be reduced and patients may not be exposed to the harms associated with more invasive cardiac testing such as coronary angiography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •TIMI score < or = to 2(12)
- •TIMI risk score of 3 with no known CAD, greater than 50% in one or more vessels
- •Normal cardiac biomarkers (3 sets over 12-88 hours)
- •No evidence of acute ischemia on electrocardiograms
- •Normal ejection fraction (>40%) on echocardiography
- •Ability to complete noninvasive stress test
- •Ability to provide informed consent
排除标准
- •Presence of another medical condition to explain chest pain or non-cardiac chest pain (i.e. pneumonia, costochondritis)
- •Any patient who is initially classified as low risk but whom develops recurrent symptoms of ischemia, hemodynamic instability, or arrhythmias attributable to ischemia
- •Evidence of ischemia on electrocardiogram
- •Abnormal cardiac biomarkers
- •History of medical noncompliance or social circumstances preventing compliance
- •Life span estimated at <1 year
- •Refusal to sign consent
研究组 & 干预措施
Non-Stress Group
Medical therapy will be implemented and will include the following: aspirin, clopidogrel, b-blockers, and statins. The dosages of aspirin, b-blocker and statin will be left to the discretion of the treating physician. Statins will be initiated irrespective of LDL unless contraindicated. Clopidogrel will be taken for at least one month and ideally up to one year. Sublingual nitroglycerin will be provided to all patients. Other anti-ischemic medications including long-acting nitrates, calcium channel blockers, and ranolazine may be provided at the treating physicians' discretion. If a patient has contraindications to any medications, they will not be administered. If a statin contraindication exists, other cholesterol-lowering medications may be administered. Appendix 4 shows the detailed management of low risk ACS patients randomized to the non-stress group.
干预措施: No Stress Test (Procedure)
Stress Group
Medical therapy will be implemented and will include the following: aspirin, clopidogrel, b-blockers, and statins. Statins will be initiated irrespective of LDL unless contraindicated. Clopidogrel will be taken for at least one month and ideally up to one year. Sublingual nitroglycerin will be provided to all patients. Other anti-ischemic medications including long-acting nitrates, calcium channel blockers, and ranolazine may be provided at the treating physicians' discretion. If a statin contraindication exists, other cholesterol-lowering medications may be administered. All patients will undergo noninvasive stress testing. Results of individual stress tests will be reviewed by a cardiologist. Based on the myocardium deemed at risk and patient symptoms, further testing with angiography and revascularization using percutaneous techniques and/or coronary artery bypass grafting may be considered. Likewise, medical treatment may be adjusted.
干预措施: Stress Test (Procedure)
结局指标
主要结局
Composite of all-cause mortality, hospitalization for UA/NSTEMI or STEMI, and urgent revascularization
时间窗: one year
Primary endpoints include the composite of all-cause mortality, hospitalization for Unstable Angina/Non ST-Elevation Myocardial Infarction (UA/NSTEMI) or ST-Elevation Myocardial Infarction (STEMI), and urgent revascularization (coronary artery bypass grafting or percutaneous coronary intervention).
次要结局
- Secondary endpoints will include mortality, UA/NSTEMI or STEMI, coronary revascularization, unplanned diagnostic coronary angiography, noninvasive stress testing, medication adjustments, and medication side effects.(one year)
研究者
Mazen Abu-Fadel, M.D.
Associate Professor of Medicine
University of Oklahoma