Non-isotope Based Imaging Modalities vs 99mTcSPECT to Detect Myocardial Ischemia in Patients at High Risk for Ischemic Cardiovascular Events
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 467
- 试验地点
- 1
- 主要终点
- Overall accuracy of "significant coronary artery disease (CAD)" according to non-invasive imaging modality
研究概览
简要总结
SPECT is currently the dominant clinical test for diagnostic and prognostic purposes as well as therapeutic decision-making. Given the shortage of nuclear reactor-produced Tc, advancing the use of non-isotope based imaging modalities has the potential to change the standard of care for patients with CAD as each one of these technics (CMR, CT, Stress echocardiography) has its own distinct potential advantages over SPECT.
详细描述
Obtain a better understanding of the clinical utility of advanced non-isotope-based imaging modalities to detect relevant CAD as potential alternatives to SPECT. Approximately 450 subjects will be enrolled in total. Three groups of about 150 patients per group. Each group will undergo imaging with 2 modalities; Group 1: 99mTcSPECT plus CMR, Group 2: 99mTcSPECT plus CT, Group 3:99mTcSPECT plus stress echocardiography. All 450 patients will undergo standard invasive coronary angiography following completion of non-invasive imaging, except for patients in whom both nuclear and non-nuclear imaging modalities reveal a normal result confirming the absence of significant coronary artery disease (i.e invasive angiography would not be clinically indicated and FFR would be considered to be above 0.8). Thrombolysis in Myocardial Infraction (TIMI) flow will be measured in all patients undergoing angiography, and fractional flow reserve (FFR) will be measured in all patients except those with TIMI flow =0, 1 and 2. All imaging procedures must be completed within 6 weeks. All patients will have a follow-up visit at 6 months after enrollment. During the 6 month follow-up visit major adverse cardiovascular events will be collected and adjudicated by a clinical endpoint committee (CEC).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 87 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinically indicated request for SPECT
- •ability to undergo at least one of three non-nuclear imaging tests; CMR, CT or Stress Echocardiography
- •History of recent symptoms suggestive of myocardial ischemia
- •High risk for ischemic cardiovascular events
排除标准
- •severely reduced systolic function (LV ejection fraction less than 35%)
- •Recent (less than 3 days) acute coronary syndrome including acute myocardial infarction
- •contraindications to dipyridamole SPECT including : i)severe reactive airway disease; ii) less than 3 days post Myocardial Infarction - Acute Coronary Syndrome (MI-ACS); iii) high-grade Atrioventricular block (AV block); iv)allergy to dipyridamole or theophylline; v) caffeine within 12 hours; vi) theophylline use within 48 hours; vii) severe claustrophobia; or viii) women who may be pregnant
- •kidney dysfunction (i.e estimated Glomerular Filtration Rate (eGFR) less than 45)
- •use of investigational drug or device within 30 days of screening visit
- •Coronary Artery Bypass Graft(s) surgery (CABG)
结局指标
主要结局
Overall accuracy of "significant coronary artery disease (CAD)" according to non-invasive imaging modality
时间窗: baseline
The overall accuracy is calculated as the probability that a subject is correctly classified (presence of significant CAD or not) by non-invasive imaging modality. The standard of truth is presence of significant CAD or not according to the invasive fractional flow reserve (FFR)
Specificity of "significant CAD" according to non-invasive imaging modality
时间窗: baseline
The specificity is calculated as the probability that a subject with absence of significant CAD according to FFR is correctly identified as such by non-invasive imaging modality
Positive predictive value of "significant CAD" according to non-invasive imaging modality
时间窗: baseline
The positive predictive value is calculated as the probability that a subject with presence of significant CAD according to non-invasive imaging modality truly have significant CAD according to FFR
Negative predictive value of "significant CAD" according to non-invasive imaging modality
时间窗: Baseline
The negative predictive value is calculated as the probability that a subject with absence of significant CAD according to non-invasive imaging modality truly does not have significant CAD according to FFR
Sensitivity of "significant CAD" according to non-invasive imaging modality
时间窗: baseline
The sensitivity is calculated as the probability that a subject with presence of significant CAD according to FFR is correctly identified as such by non-invasive imaging modality
次要结局
- Sensitivity of "high-risk CAD" according to non-invasive imaging modality flow and FFR(Baseline)
- Overall accuracy of "high-risk CAD" according to non-invasive imaging modality flow and FFR(baseline)