Evaluation of the Diagnostic Performance of Dynamic Myocardial Perfusion Scintigraphy in Comparison With Invasive Intracoronary FFR Measurement, in the Assessment of Significant Residual Coronary Stenosis After Acute Coronary Syndrome: Dyna-MI Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Sensitivity, specificity, predictive positive value, negative predictive value, accuracy of MFR in comparison with FFR
研究概览
简要总结
Dynamic 99mTc-Tetrofosmin CZT-SPECT myocardial perfusion imaging (MPI) is an advanced functional imaging technique giving important myocardial flow quantification added data in comparison with conventional MPI, especially in coronary multi vessel disease. A large-scale validation of diagnostic performances of myocardial flow reserve (MFR) estimated with Dynamic 99mTc-Tetrofosmin CZT-SPECT MPI would allow a non-invasive approach instead of invasive intra-coronary fractional flow reserve (FFR) measurement. The aim of this prospective study is to assess diagnostic performances of MFR calculated with dynamic 99mTc-Tetrofosmin CZT-SPECT MPI in comparison with invasive intra-coronary FFR measurement in patients with significant residual coronary arteries stenosis after acute coronary syndrome .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient.
- •Multi vessel coronary arteries disease (at least one non-culprit coronary stenosis >= 50%) diagnosis during
- •primary percutaneous coronary intervention < 12h after ST-elevation myocardial infarction opercutaneous revascularisation of the culprit lesion within 24 to 48 hours of an acute non-ST-segment elevation coronary syndrome.
- •Written consent.
- •Social security affiliation
排除标准
- •Non adult patient.
- •Adult patient under tutelage.
- •Reproductive age women.
- •Medical history of myocardial infarction or coronary artery bypass surgery.
- •Cardiogenic shock.
- •Cardiomyopathy.
- •Regadenoson/adenosine/FFR contraindication.
- •99mTc-Tetrofosmin hypersensibility.
- •Small non-culprit coronary arteries.
- •Participation to another interventional study.
研究组 & 干预措施
Single arm study
Patients included in the study will undergo subsequently at 1-month after acute coronary syndrome Dynamic 99mTc-Tetrofosmin CZT-SPECT followed by FFR and IMR assessment
干预措施: Dynamic 99mTc-Tetrofosmin CZT-SPECT (Diagnostic Test)
结局指标
主要结局
Sensitivity, specificity, predictive positive value, negative predictive value, accuracy of MFR in comparison with FFR
时间窗: within one month after ST-elevation myocardial infarction
To determine MFR diagnostic performances in comparison with FFR
次要结局
- Sensitivity, specificity, predictive positive value, negative predictive value, accuracy of MFR in comparison with conventional static MPI(within one month after ST-elevation myocardial infarction)
- MFR value correlated with IMR(within one month after ST-elevation myocardial infarction)
- Sensitivity, specificity, predictive positive value, negative predictive value, accuracy of QFR in comparison with FFR value(within one month after ST-elevation myocardial infarction)
- best MFR cut-off value(within one month after ST-elevation myocardial infarction)