Non-isotope Based Imaging Modalities vs Technetium-99m Single-Photon Emission Computed Tomography(99mTcSPECT) (MITNECB5)
2020年2月20日 更新者：Montreal Heart Institute
Non-isotope Based Imaging Modalities vs 99mTcSPECT to Detect Myocardial Ischemia in Patients at High Risk for Ischemic Cardiovascular Events
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.
研究概览
地位
完全的
条件
详细说明
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).
研究类型
观察性的
注册 (实际的)
467
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Quebec
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Montreal、Quebec、加拿大
- Montreal Heart Institute
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 87年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Approximately 450 patients across Canada.
Patients will be identified after a clinically indicated SPECT for evaluation of myocardial ischemia.The investigator will assign the patient in one of the three groups based on his medical assessment and availability of equipment at the centre.
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
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Diagnosis
Group 3: 99mTCSPECT plus stress echocardiography
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group 1 : diagnosis
Group 1: 99mTcSPECT plus CMR
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Group 2: diagnosis
Group 2: 99mTcSPECT plus CT
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Overall accuracy of "significant coronary artery disease (CAD)" according to non-invasive imaging modality
大体时间：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)
|
baseline
|
|
Sensitivity of "significant CAD" according to non-invasive imaging modality
大体时间：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
|
baseline
|
|
Specificity of "significant CAD" according to non-invasive imaging modality
大体时间：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
|
baseline
|
|
Positive predictive value of "significant CAD" according to non-invasive imaging modality
大体时间：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
|
baseline
|
|
Negative predictive value of "significant CAD" according to non-invasive imaging modality
大体时间：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
|
Baseline
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Overall accuracy of "high-risk CAD" according to non-invasive imaging modality flow and FFR
大体时间：baseline
|
baseline
|
|
Sensitivity of "high-risk CAD" according to non-invasive imaging modality flow and FFR
大体时间：Baseline
|
Baseline
|
其他结果措施
结果测量 |
大体时间 |
|---|---|
|
Specificity of "high-risk CAD" according to non-invasive imaging modality flow and FFR
大体时间：baseline
|
baseline
|
|
Positive predictive value of "high-risk CAD" according to non-invasive imaging modality flow and FFR
大体时间：baseline
|
baseline
|
|
Negative predictive value of "high-risk CAD" according to non-invasive imaging modality flow and FFR
大体时间：baseline
|
baseline
|
|
Overall accuracy of "high-risk CAD" according to non-invasive imaging modality to predict occurrence of the composite clinical endpoint of major adverse cardiovascular events (MACE)
大体时间：baseline
|
baseline
|
|
Sensitivity of "high-risk CAD" according to non-invasive imaging modality to predict occurrence of the composite clinical endpoint of major adverse cardiovascular events (MACE)
大体时间：baseline
|
baseline
|
|
Specificity of "high-risk CAD" according to non-invasive imaging modality to predict occurrence of the composite clinical endpoint of major adverse cardiovascular events (MACE)
大体时间：baseline
|
baseline
|
|
Positive predictive value of "high-risk CAD" according to non-invasive imaging modality to predict occurrence of the composite clinical endpoint of major adverse cardiovascular events (MACE)
大体时间：baseline
|
baseline
|
|
Negative predictive value of "high-risk CAD" according to non-invasive imaging modality to predict occurrence of the composite clinical endpoint of major adverse cardiovascular events (MACE)
大体时间：baseline
|
baseline
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Jean-Claude Tardif, M.D、Montreal Heart Institute
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年10月1日
初级完成 (实际的)
2018年5月1日
研究完成 (实际的)
2019年4月18日
研究注册日期
首次提交
2013年7月18日
首先提交符合 QC 标准的
2013年10月24日
首次发布 (估计)
2013年10月30日
研究记录更新
最后更新发布 (实际的)
2020年2月21日
上次提交的符合 QC 标准的更新
2020年2月20日
最后验证
2020年2月1日
更多信息
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