MyocardiAl CT Perfusion and Coronary Flow: a CompreHensive Cardiac CT Myocardial Perfusion Imaging (MPI)/Fractional Flow Reserve (FFR) and PET-CT MPI Evaluation (The MATCH Investigation)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Myocardial Blood Flow
研究概览
简要总结
The overall goal of this project is to compare the absolute quantification of myocardial perfusion done by using CT myocardial perfusion imaging (CT-MPI) and the coronary flow measured by using CT Fractional Flow Reserve analysis (CT-FFR) to the gold standard represented by PET myocardial perfusion imaging (PET-MPI).
详细描述
Participants will be patients who are scheduled to undergo PET Myocardial Perfusion Imaging, which is the traditional method for evaluating patients with suspected blockages or narrowing of the heart vessels (coronary artery disease) causing impaired blood to flow to the heart muscle (myocardium).
The purpose of the study is to determine and compare the newest heart imaging equipment which allows the non-invasive evaluation of coronary anatomy, coronary flow and myocardial perfusion in patients with suspected or proven coronary artery disease (CAD) with the actual gold-standard for quantitative myocardial perfusion assessment. In order to achieve this aim, the study team will compare heart scan results from a computed tomography (CT) Myocardial Perfusion Imaging (CT-MPI) scan and CT-Fractional Flow Reserve (FFR) with the actual standard clinical care represented by a PET Myocardial Perfusion Imaging (PET-MPI) study.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Referred for a clinically indicated CT-MPI for CAD assessment
- •Must provide written informed consent prior to any study-related procedures being performed
- •Must be willing to comply with all clinical study procedures
排除标准
- •Pregnant or nursing females. The possibility of pregnancy will be excluded by testing (serum or urine ßHCG) within 24 hours before study agent administration, or if the woman has previous surgical sterilization, or if the woman is post-menopausal, with minimum one (1) year history without menses.
- •Currently taking or has taken within 48 hours the following excluded medications:
- •ActoPlus Met (Pioglitazone + metformin)
- •Avandamet (Rosiglitazone + metformin)
- •Fortamet (metformin)
- •Glucovance (Glyburide +metformin)
- •Glucophage (metformin)
- •Glucophage extended-release (XR) (metformin)
- •Glumetza (metformin)
- •Janumet (Sitagliptin + metformin)
- •Metformin
- •Metaglip (Glipizide + metformin)
- •Riomet (metformin)
- •Acute psychiatric disorder
- •Unwilling to comply with the requirements of the protocol
- •Previously entered this study
- •Known hypersensitivity to iodinated contrast material, beta-blockers, or pharmaceutical stressors used in this study
- •Suffers from claustrophobia
- •Impaired renal function (GFR < 45 ml/min)
- •Acute hypotension (<100 mm Hg systolic)
- •2nd or 3rd degree atrioventricular (AV) block
研究组 & 干预措施
Three imaging techniques: PET-MPI, CT-MPI, and CT-FFR
Participants referred for a clinical PET-MPI will also have CT-MPI and CT-FFR imaging performed for analysis of myocardial perfusion.
干预措施: Regadenoson (Drug)
Three imaging techniques: PET-MPI, CT-MPI, and CT-FFR
Participants referred for a clinical PET-MPI will also have CT-MPI and CT-FFR imaging performed for analysis of myocardial perfusion.
干预措施: PET-MPI Protocol (Diagnostic Test)
Three imaging techniques: PET-MPI, CT-MPI, and CT-FFR
Participants referred for a clinical PET-MPI will also have CT-MPI and CT-FFR imaging performed for analysis of myocardial perfusion.
干预措施: CT-MPI (Diagnostic Test)
Three imaging techniques: PET-MPI, CT-MPI, and CT-FFR
Participants referred for a clinical PET-MPI will also have CT-MPI and CT-FFR imaging performed for analysis of myocardial perfusion.
干预措施: Coronary CT angiography (CCTA) for CT-FFR calculation (Diagnostic Test)
结局指标
主要结局
Myocardial Blood Flow
时间窗: Day of PET-MPI Scan, and Day of CT-MPI and CT-FFR Scans (up to 90 days)
The absolute quantification of myocardial perfusion between CT-MPI and PET-MPI is compared. Myocardial perfusion is quantified using appropriate tracer kinetic models resulting myocardial blood flow mL/g/min.
Specificity of Myocardial Perfusion Abnormalities Diagnosis
时间窗: Day 1 (day of scans)
The accuracy of detection of myocardial perfusion abnormalities is compared between PET-MPI, CT-MPI, CCTA, and CT-FFR approach. Diagnostic accuracy using CT-MPI, CCTA and CT-FFR is calculated as specificity (true negatives) with PET as the reference standard.
Coronary Flow Per CT-FFR
时间窗: Day of CT-MPI and CCTA scans
Coronary flow is measured using the CT-FFR calculation with the CCTA scans. CT-FFR measures blood flow through coronary arteries and is used clinically to quantify the severity of CAD to determine further interventions. CT-FFR is the ratio between the blood flow (BF) in a diseased artery and a normal artery. Clinically, the CT-FFR calculation is only useful in patients with intermediate stenosis because stenosis below intermediate results in a value that is near zero and the calculation cannot be performed when stenosis is complete. The normal range for CT-FFR is greater than 0.80, values of 0.76 to 0.80 are borderline while values of 0.75 or less are associated with a high likelihood of reduced blood flow (ischemia).
Sensitivity of Coronary Stenosis Diagnosis
时间窗: Day 1 (day of scans)
The accuracy of detection of coronary stenosis is compared between PET-MPI, CT-MPI, and CCTA with CT-FFR approach. Diagnostic accuracy is calculated as sensitivity (true positives) with CCTA as the reference standard.
Sensitivity of Myocardial Perfusion Abnormalities Diagnosis
时间窗: Day 1 (day of scans)
The accuracy of detection of myocardial perfusion abnormalities is compared between PET-MPI, CT-MPI, CCTA, and CT-FFR approach. Diagnostic accuracy using CT-MPI, CCTA and CT-FFR is calculated as sensitivity (true positives) with PET as the reference standard.
Area Under the Curve (AUC) for Detection of Myocardial Perfusion Abnormalities
时间窗: Day 1 (day of scans)
The accuracy of detection of myocardial perfusion abnormalities is compared between PET-MPI, CT-MPI, CCTA, and CT-FFR approach. Diagnostic accuracy using CT-MPI, CCTA and CT-FFR is calculated as overall AUC with PET as the reference standard. The AUC examines the overall accuracy of a diagnostic test. Higher AUC indicates greater accuracy in detecting myocardial perfusion abnormalities with 1.0 being 100% accurate. An AUC value of 0.5 indicates that the test is as accurate as random chance.
Specificity of Coronary Stenosis Detection
时间窗: Day 1 (day of scans)
The accuracy of detection of coronary stenosis is compared between PET-MPI, CT-MPI, and CCTA with CT-FFR approach. Diagnostic accuracy is calculated as specificity (true negatives) with CCTA as the reference standard.
Area Under the Curve for Detection of Coronary Stenosis
时间窗: Day 1 (day of scans)
The accuracy of detection of coronary stenosis is compared between PET-MPI, CT-MPI, and CCTA with CT-FFR approach. Diagnostic accuracy is calculated as overall AUC with CCTA as the reference standard. The AUC examines the overall accuracy of a diagnostic test. Higher AUC indicates greater accuracy in detecting coronary stenosis with 1.0 being 100% accurate. An AUC value of 0.5 indicates that the test is as accurate as random chance.
次要结局
未报告次要终点
研究者
Carlo N. De Cecco
Associate Professor
Emory University