Ability of FFR-CT to Detect the Absence of Hemodynamically Significant Lesions in Patients With High-risk Acute Coronary Syndrome Admitted in the Emergency Department With Chest Pain: a Diagnostic Accuracy Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Negative predictive value of FFR-CT to detect the absence of hemodynamically significant stenosis, compared to angiography (with FFR in case of lesion with at least a 30% stenosis) in high risk ACS patients
研究概览
简要总结
The present study is a monocentric, observational, single arm, study, with the aim to determinate the ability of FFR-CT to exclude or confirm the presence of hemodynamically significant coronary stenosis, compared to coronary angiography in high-risk acute coronary syndrome patients.
详细描述
Study Design and Procedure:
The present study is a single arm, double blinded, prospective trial. Patients admitted to hospital with high-risk non-ST elevation acute coronary syndrome (NSTE-ACS) and who accept to participate to the study will undergo a coronary compute tomography (CT) angiography within 23 hours after diagnosis in order to have time to proceed to coronary angiography within the recommended window time of 24h. After realization of the CT, they will benefit from guidelines recommended treatment including a coronary angiography. According to internal and international guidelines, all efforts will be made to perform the coronary angiography within 24h of acute coronary syndrome (ACS) diagnosis.
The coronary CT angiography procedure takes approximately 1-2h (including logistical organization and patient transportation), and all efforts will be made not to delay the coronary angiography compared to patients who would not participate in the study. At the time of coronary angiography, patients will be blinded from the CT results as well as the direct treating physician and interventional cardiologist realizing the procedure, in order to avoid any influence in patients' management. The procedure will be done using a 256-slice multi-detector CT (GE Healthcare Revolution CT, Chicago, Illinois, USA). Just before the examination, as routinely done for this non-invasive test to allow for optimal coronary vasodilation and visualization, oral Metoprolol (25-50mg) will be administered if necessary to ensure a heart rate of 65 bpm or lower as well as one unique dose of sublingual nitroglycerine (400-800mg). Parameters used for CT acquisition will be as following: 100 Kilovoltage peak (kVp)/550 milliamperes (mA) for body mass index (BMI) <25 (high definition mode), 100 kVp/550 mA for BMI included between 25 and 30, 120 kVp/600 mA for BMI>30 (standard definition mode). Off line, an FFR-CT will be calculated with the data of the coronary CT angiography by blinded investigators in a central FFR-CT core laboratory (HeartFlow ®, Redwood City, CA 94063, USA). Hemodynamically significant lesion will be defined as lesion with an FFR-CT value of ≤ 0.80.
During the invasive coronary angiography, fractional flow reserve (FFR) will be measured in all lesions with a visual diameter stenosis ≥30% using the PressureWire™ X Guidewire (Abbott, Chicago, Illinois, USA) with the following protocol: first, equalization of the pressure wire and the aortic pressure will be performed at the tip of the guide catheter prior to all measurements. Second, the pressure wire will then be advanced distal to the stenosis. Third, hyperemia will be obtained using intracoronary adenosine (150mcg for the right coronary artery and 200mcg for the left descending or the circumflex coronary arteries). Fourth, at the end of the procedure, the absence of a drift will be confirmed after a pull-back of the pressure to the same location as the initial equalization. Hemodynamically significant lesion will be defined as lesion with an FFR value of ≤ 0.80.
Of note, in case of coronary angiography showing no obstructive coronary disease, and thus not offering satisfactory explanation for the myocardial injury, patients will undergo cardiac magnetic resonance imaging (CMRI), to detect a potential alternative diagnosis (myocarditis, Takotsubo...).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Negative predictive value of FFR-CT to detect the absence of hemodynamically significant stenosis, compared to angiography (with FFR in case of lesion with at least a 30% stenosis) in high risk ACS patients
时间窗: Through inclusion completion, expected after 18 months of enrolment
Accuracy of FFR-CT to detect hemodynamically significant stenosis, compared to angiography (with FFR in case of lesion with at least a 30% stenosis) in high risk ACS patients
时间窗: Through inclusion completion, expected after 18 months of enrolment
Sensitivity of FFR-CT to detect hemodynamically significant stenosis, compared to angiography (with FFR in case of lesion with at least a 30% stenosis) in high risk ACS patients
时间窗: Through inclusion completion, expected after 18 months of enrolment
Specificity of FFR-CT to detect hemodynamically significant stenosis, compared to angiography (with FFR in case of lesion with at least a 30% stenosis) in high risk ACS patients
时间窗: Through inclusion completion, expected after 18 months of enrolment
Positive predictive value of FFR-CT to detect hemodynamically significant stenosis, compared to angiography (with FFR in case of lesion with at least a 30% stenosis) in high risk ACS patients
时间窗: Through inclusion completion, expected after 18 months of enrolment
次要结局
- Positive predictive value of coronary CT to detect hemodynamically significant stenosis, compared to angiography (with FFR in case of lesion with at least a 30% stenosis) in high-risk ACS patients(Through inclusion completion, expected after 18 months of enrolment)
- Accuracy of coronary CT to detect hemodynamically significant stenosis, compared to angiography (with FFR in case of lesion with at least a 30% stenosis) in high-risk ACS patients(Through inclusion completion, expected after 18 months of enrolment)
- Negative predictive value of coronary CT to detect the absence of hemodynamically significant stenosis, compared to angiography (with FFR in case of lesion with at least a 30% stenosis) in high-risk ACS patients(Through inclusion completion, expected after 18 months of enrolment)
- Sensitivity of FFRangio™ to detect hemodynamically significant stenosis, compared to FFR-CT in high-risk ACS patients(Through inclusion completion, expected after 18 months of enrolment)
- Positive predictive value of FFRangio™ to detect hemodynamically significant stenosis, compared to FFR-CT in high-risk ACS patients(Through inclusion completion, expected after 18 months of enrolment)
- Sensibility of coronary CT to detect hemodynamically significant stenosis, compared to angiography (with FFR in case of lesion with at least a 30% stenosis) in high-risk ACS patients(Through inclusion completion, expected after 18 months of enrolment)
- Specificity of coronary CT to detect hemodynamically significant stenosis, compared to angiography (with FFR in case of lesion with at least a 30% stenosis) in high-risk ACS patients(Through inclusion completion, expected after 18 months of enrolment)
- Specificity of FFRangio™ to detect hemodynamically significant stenosis, as compared to invasive FFR in high-risk ACS patients(Through inclusion completion, expected after 18 months of enrolment)
- Positive predictive value of FFRangio™ to detect hemodynamically significant stenosis, as compared to invasive FFR in high-risk ACS patients(Through inclusion completion, expected after 18 months of enrolment)
- Accuracy of FFRangio™ to detect hemodynamically significant stenosis, compared to FFR-CT in high-risk ACS patients(Through inclusion completion, expected after 18 months of enrolment)
- Correlation (goodness of fit) of FFR-CT to detect hemodynamically significant stenosis, compared to invasive FFR in lesions with at least a 30% stenosis(Through inclusion completion, expected after 18 months of enrolment)
- Feasibility of an FFR-CT strategy in case of high-risk ACS, defined as the number of cases among enrolled patients where CT and FFR-CT is not feasible (moving artefacts, quality…)(Through inclusion completion, expected after 18 months of enrolment)
- Accuracy, of FFRangio™ to detect hemodynamically significant stenosis, as compared to invasive FFR in high-risk ACS patients(Through inclusion completion, expected after 18 months of enrolment)
- Natural history of deferred lesions according to invasive FFR in term of major adverse cardiac events (MACE)(Through follow-up completion, expected 30 months after study initiation)
- Safety endpoint(Through inclusion completion, expected after 18 months of enrolment)
- Sensitivity of FFRangio™ to detect hemodynamically significant stenosis, as compared to invasive FFR in high-risk ACS patients(Through inclusion completion, expected after 18 months of enrolment)
- Negative predictive value of FFRangio™ to detect hemodynamically significant stenosis, as compared to invasive FFR in high-risk ACS patients(Through inclusion completion, expected after 18 months of enrolment)
- Specificity of FFRangio™ to detect hemodynamically significant stenosis, compared to FFR-CT in high-risk ACS patients(Through inclusion completion, expected after 18 months of enrolment)
- Distribution of treatment assignement (PCI, CABG, medical treatment), based on angiography versus treatment decision according to FFRangio™ in high-risk ACS patients(Through inclusion completion, expected after 18 months of enrolment)
- Natural history of deferred lesions according to FFRangio™ in term of major adverse cardiac events (MACE)(Through follow-up completion, expected 30 months after study initiation)
- Negative predictive value of FFRangio™ to detect hemodynamically significant stenosis, compared to FFR-CT in high-risk ACS patients(Through inclusion completion, expected after 18 months of enrolment)
- Distribution of treatment assignement (PCI, CABG, medical treatment), based on angiography versus treatment decision according to invasive FFR in high-risk ACS patients(Through inclusion completion, expected after 18 months of enrolment)
- Distribution of treatment assignement (PCI, CABG, medical treatment), based on angiography versus treatment decision according to FFR-CT in high-risk ACS patients(Through inclusion completion, expected after 18 months of enrolment)
- Natural history of deferred lesions according to FFR-CT, in term of major adverse cardiac events (MACE)(Through follow-up completion, expected 30 months after study initiation)
- Natural history of deferred lesions according to CT in term of major adverse cardiac events (MACE)(Through follow-up completion, expected 30 months after study initiation)
研究者
Dr. Stephane Fournier
Chief Resident, Principal Investigator
Centre Hospitalier Universitaire Vaudois