Multisensor Wireless Pressure Microcatheter For Microvascular Function Assessment In ANOCA/INOCA Patients: A Prospective, Multicenter, Single-Group Target Value Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 114
- 试验地点
- 7
- 主要终点
- Sensitivity and specificity of multi-sensor wireless pressure microcatheter for calculating Coronary Flow Reserve (CFR) in diagnosing Coronary Microvascular Dysfunction (CMD)
研究概览
简要总结
This study aims to evaluate the sensitivity and specificity of a multi-sensor wireless pressure microcatheter for the diagnosis of CMD in patients with ANOCA/INOCA, using quantitative myocardial perfusion imaging of cardiac magnetic resonance (CMR) as a reference.
详细描述
This is a prospective, multicenter, single-group target value study, which aims to enroll patients with angina symptoms or objective evidence of myocardial ischemia, whose coronary angiography visual assessment shows a diameter stenosis of <50% and an FFR >0.8 (or cRR >0.89).
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
- •Age ≥ 18 years, gender not limited;
- •Symptoms of angina pectoris, or objective evidence of myocardial ischemia (e.g., electrocardiogram, myocardial injury markers, etc.);
- •Visual assessment of coronary angiography shows diameter stenosis < 50% and FFR > 0.8 (or cRR > 0.89);
- •Microvascular function assessment is planned;
- •Agree to participate in this clinical study and voluntarily sign the informed consent form.
排除标准
- •Acute myocardial infarction, PCI, CABG, or valvular surgery following angiography within the past 30 days;
- •Severe valvular disease requiring surgical or interventional treatment;
- •Chest pain with known non-ischemic causes (e.g., pericarditis, pulmonary hypertension, esophageal spasm);
- •Contraindications to CMR (e.g., certain types of pacemakers or defibrillators, severe claustrophobia);
- •Clear contraindications to adenosine and ATP use (e.g., second- or third-degree atrioventricular block, sick sinus syndrome, severe asthma, systolic blood pressure below 90 mmHg);
- •Renal insufficiency (eGFR ≤ 45 mL/min/1.73 m2) or currently undergoing dialysis;
- •Severe heart failure or LVEF ≤ 35%;
- •Severe organ disease or life expectancy less than 2 years;
- •Known to be participating in other drug or device clinical trials that have not yet met the primary endpoint;
- •Other investigators deem the candidate unsuitable for this clinical trial.
结局指标
主要结局
Sensitivity and specificity of multi-sensor wireless pressure microcatheter for calculating Coronary Flow Reserve (CFR) in diagnosing Coronary Microvascular Dysfunction (CMD)
时间窗: Intraoperative period (day 0) and post-operative (days 1-7)
Using study participants as the unit of study, and with Myocardial Perfusion Reserve (MPR) calculated by Cardiac Magnetic Resonance (CMR) quantitative myocardial perfusion imaging as the reference (MPR\<2.2 is positive, MPR≥2.2 is negative), the sensitivity and specificity of CFR calculated by multi-sensor wireless pressure microcatheter for diagnosing CMD (CFR\<2.5 is positive, CFR≥2.5 is negative) were evaluated.
次要结局
- Multi-sensor wireless pressure microcatheter calculation of CFR for diagnosing CMD: accuracy, positive predictive value, negative predictive value, Receiver Operating Characteristic Curve (ROC), and Area Under the Curve（AUC）(Intraoperative period (day 0) and post-operative (days 1-7))
- Pearson correlation analysis and Bland-Altman bias analysis of CFR calculated by multi-sensor wireless pressure microcatheter and MPR calculated by CMR quantitative myocardial perfusion imaging.(Intraoperative period (day 0) and post-operative (days 1-7))
- Pearson correlation analysis of multi-sensor wireless pressure microcatheter measurements of Tmn,rest and Tmn,hyper with CMR quantitative myocardial perfusion imaging measurements of MBFrest and MBFhyper.(Intraoperative period (day 0) and post-operative (days 1-7))
- Multi-sensor wireless pressure microcatheter calculation of Index of Microcirculatory Resistance (IMR) for diagnosing CMD: accuracy, sensitivity, specificity, positive predictive value, negative predictive value, ROC, and AUC.(Intraoperative period (day 0) and post-operative (days 1-7))
- Multi-sensor wireless pressure microcatheter calculation of Microvascular Resistance Reserve (MRR) for diagnosing CMD: accuracy, sensitivity, specificity, positive predictive value, negative predictive value, ROC, and AUC.(Intraoperative period (day 0) and post-operative (days 1-7))