PROspective Multicenter Imaging Study for Evaluation of Chest Pain - The PROMISE Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10,003
- 试验地点
- 2
- 主要终点
- Time to Primary Endpoint
研究概览
简要总结
A prospective multicenter imaging study for evaluation of chest pain. Objective is to determine whether an initial non-invasive anatomic imaging strategy with coronary CT angiography (CTA) will improve clinical outcomes in subjects with symptoms concerning for coronary artery disease relative to an initial functional testing strategy (usual care). Study hypothesis: initial anatomic testing strategy will provide information that will result in superior long-term health outcomes as compared to an initial functional testing strategy.
详细描述
Pragmatic randomized trial of clinical effectiveness of diagnostic testing strategies for coronary artery disease (CAD), to be performed in outpatient settings including acute and primary care and cardiology offices. Qualifying patients presenting with new or worsening symptoms suspicious for clinically significant CAD who require diagnostic testing and have not been previously evaluated will be randomized to an initial strategy of either anatomic or functional testing. All subsequent decisions regarding additional testing, medications and/or procedures will be at the discretion of the responsible clinical care team Within the functional testing arm, the subject's care team will select the specific test to be performed (exercise electrocardiogram (ECG), stress nuclear, or stress echocardiogram (echo)) consistent with 'usual care' in that practice setting. The subject's care team will be provided with 'Information sheets' summarizing current standards for test interpretation and preventive care, but specific medical treatment will not be mandated by the trial.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •new or worsening chest pain suspicious for clinically significant coronary artery disease (CAD)
- •no prior evaluation for this episode of symptoms
- •planned non-invasive testing for diagnosis
- •men age ≥55 years
- •men age ≥45 years with increased probability of coronary artery disease (CAD) due to either (A. Diabetes Mellitus (DM) requiring medical treatment OR Peripheral Arterial Disease (PAD) defined as documented >50% peripheral arterial stenosis treated medically or invasively OR cerebrovascular disease (stroke, documented > 50% carotid stenosis treated medically or invasively) OR B. At least one of the following cardiovascular risk factors: 1-Ongoing tobacco use, 2-Hypertension, 3-Abnormal ankle brachial index (ABI) defined as less than <0.9, 4-Dyslipidemia
- •women age ≥65 years
- •women age ≥50 years with increased probability of coronary artery disease (CAD) due to either (A. Diabetes Mellitus (DM) requiring medical treatment OR Peripheral Arterial Disease (PAD) defined as documented >50% peripheral arterial stenosis treated medically or invasively OR cerebrovascular disease (stroke, documented > 50% carotid stenosis treated medically or invasively) OR B. At least one of the following cardiovascular risk factors: 1-Ongoing tobacco use, 2-Hypertension, 3-Abnormal ankle brachial index (ABI) defined as less than <0.9, 4-Dyslipidemia
- •Serum creatinine ≤ 1.5 mg/dL within the past 90 days
- •Negative urine/serum pregnancy test for female subjects of child-bearing potential
排除标准
- •Diagnosed or suspected acute coronary syndrome (ACS) requiring hospitalization or urgent or emergent testing; Elevated troponin or creatine kinase-myocardial band (CK-MB)
- •Hemodynamically or clinically unstable condition systolic blood pressure (BP) < 90 mmHg, atrial or ventricular arrhythmias, or persistent resting chest pain felt to be ischemic despite adequate therapy)
- •Known coronary artery disease (CAD) with prior Myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or any angiographic evidence of coronary artery disease (CAD) ≥50% lesion in a major epicardial vessel
- •Any invasive coronary angiography or non-invasive anatomic or functional cardiovascular (CV) test for detection of coronary artery disease (CAD), including coronary tomographic angiography (CTA) and exercise electrocardiogram (ECG), within the previous twelve (12) months
- •Known significant congenital, valvular (> moderate) or cardiomyopathic process (hypertrophic cardiomyopathy or reduced systolic left ventricular function (LVEF) ≤ 40%)) which could explain cardiac symptoms
- •Contraindication to undergoing a coronary tomographic angiography (CTA), including but not limited to: a. Allergy to iodinated contrast agent, b. Unable to receive beta blockers unless heart rate < 65 beats per minute, c. Pregnancy
- •Life expectancy < 2 years
- •Unable to provide written informed consent or participate in long-term follow-up
结局指标
主要结局
Time to Primary Endpoint
时间窗: 90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months
Time to primary endpoint as defined as a composite of death, myocardial infarction (MI), major complications from cardiovascular (CV) procedures or testing, and unstable angina hospitalization. The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.
次要结局
- Time to Death, Myocardial Infarction (MI), Unstable Angina Hospitalization(90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months)
- Time to Major Complications From Cardiovascular (CV) Procedures(90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months)
- Quality of Life (QOL) as Measured by Complete Resolution of Symptoms That Led to the Initial Testing(6 month, 12 month 24 month)
- Time to Death or Myocardial Infarction (MI)(90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months)
- Quality of Life (QOL) as Measured by Duke Activity Status Index(Baseline, 6 months, 12 months 24 months)
- Time to Death, Myocardial Infarction (MI), Unstable Angina (UA), Complications, No Coronary Artery Disease (CAD)(90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months)
- Percentage of Invasive Cardiac Catheterization Events Without Obstructive Coronary Artery Disease Within 90 Days Following Participant Randomization(Up to 90 days following participant randomization)
- Cumulative Radiation Exposure Within 90 Days(90 days)
- Medical Cost(90 days and 3 years cumulative)
- Quality of Life (QOL) as Measured by Seattle Angina Scale Anginal Frequency Subscale(Baseline, 6 month, 12 month, 24 month)
- Quality of Life (QOL) as Measured by Seattle Anginal Quality of Life Subscale(Baseline, 6 months, 12 months, 24 months)