Evaluation of Diagnostic Accuracy, Safety, and Cost-Effectiveness of the Non-Invasive Cardiolens FFR-CT Pro Method to Measure the Fractional Flow Reserve in Diagnostics of Chronic Coronary Syndromes Versus the Standard Diagnostic Modalities. A Multicentre Post-marketing Trial of a Class 2a Medical Device, Cardiolens FFR-CT Pro - Software for Non-invasive Determination of Haemodynamic Parameters in Coronary Arteries.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 450
- 试验地点
- 11
- 主要终点
- The evaluation of the increased diagnostic accuracy of the non-invasive Cardiolens FFR-CT Pro technology
研究概览
简要总结
A multicentre, post-marketing, observational trial in 450 patients, whose standard diagnostic workup for chronic coronary syndromes provided for Invasive Coronary Angiography (ICA). Medical records of a potential subject of the trial before their enrolment contain a good quality result of at least 128-slice CCTA performed up to 3 months before the elective ICA. CCTA should find at least one ≥50% stenosis in at least one big coronary artery of ≥ 2 mm diameter. At one hour before ICA in the latest the patient should have a resting Continuous Non-Invasive Blood Pressure (CNBP) taken with a certified device delivered by LifeFlow. The last criterion before including a patient in the final analysis is at least one significant (≥50%) stenosis in one or two coronary arteries of ≥ 2 mm diameter visually confirmed by ICA with a FFR measurement taken in these arteries.
The data collection period will cover time from admission for the elective ICA to discharge from the hospital (evaluation of possible adverse events related to invasive procedures).
After initial qualification of available data by the attending physician, selected patients will be asked for a consent to participation in the trial no later than upon admission for the elective ICA and before CNBP measurement.
详细描述
Stage 1
After a patient declares their consent, a doctor or another member of the study team trained by the sponsor will perform procedures in the following order:
- Define the unique patient ID to be recorded in the CRF with the patient's demographic data
- Assess the quality of CCTA imaging data (DICOM) according to guidelines agreed upon with the sponsor and record the number and location of the significant (≥50%) stenosis sites in the CRF based on CCTA
- No later than one hour before ICA starts, perform a physical examination consisting in instantaneous peripheral blood pressure (systolic and diastolic) resting measurement performed with a standard sphygmomanometer and Continuous Non-Invasive Blood Pressure measurement (1-3 min).
Stage 2
After the procedures mentioned above are performed, the patient will undergo elective ICA with the outcomes, i.e.:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Declaration of informed consent to sharing medical records gathered during the standard diagnostic workup
- •History of chronic coronary syndromes (CCS)
- •Diagnostic CCTA (good quality test allowing investigation of the entire coronary artery tree), showing at least one site with stenosis ≥50% of the lumen in a large coronary artery of ≥ 2 mm diameter, with no prior revascularisation
- •Standard treatment of chronic coronary syndromes with no dosage modification required within at least 4 weeks before the enrolment
- •Patients with a prior acute coronary syndrome (ACS) or revascularisation would be found eligible under the following conditions:
- •Over 30 days from the acute coronary syndrome occurrence
- •FFR assessment during ICA may only cover the vessels that were not revascularized (both PCI and CABG) and were not the reason of ACS
- •No closed coronary arteries
排除标准
- •CCTA-confirmed myocardial bridges causing >50% stenosis of the epicardial vascular lumen
- •Coronary obstruction confirmed by CCTA or invasive coronarography
- •History of ACS with coronary angioplasty or Coronary Artery Bypass Grafting (CABG) performed unless point 6 conditions are met
- •Significant haemodynamic abnormalities of the valve or history of surgical correction of the defect or CABG
- •Second-degree or third-degree atrioventricular block, sinus node dysfunction, QTc > 450 ms or prolonged QTc
- •LVEF ≤ 35% found in an echocardiogram performed within the last 6 months
- •Clinically apparent infection
- •Thrombocytopenia below 100.000/mm3
- •Active neoplastic disease (apart from basal cell carcinoma and carcinoma in situ) and other conditions, which, in the investigator's opinion significantly affect their life expectancy
- •Other significant conditions, infections, addictions and psychological or social factors, which, in the doctor's opinion, may affect patient's ability to participate in the trial or significantly affect their safety
结局指标
主要结局
The evaluation of the increased diagnostic accuracy of the non-invasive Cardiolens FFR-CT Pro technology
时间窗: Up to 18 months
Evaluation of the increased diagnostic accuracy (area under ROC curve, AUC) in detection of haemodynamically significant stenoses in coronary arteries with a non-invasive Cardiolens FFR-CT Pro technology compared to CCTA in reference to the invasive fractional flow reserve (FFR) testing at the arterial level.
次要结局
- The evaluation of safety of the non-invasive Cardiolens FFR-CT Pro technology(Up to 5 days. The date from admission for the scheduled ICA to discharge from the hospital.)
- The evaluation of diagnostic accuracy of the non-invasive Cardiolens FFR-CT Pro technology(Up to 18 months)
- The evaluation of the costs of Cardiolens FFR-CT Pro technology(Up to 5 days. The date from admission for the scheduled ICA to discharge from the hospital.)