Overview
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.
Description
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).
Eligibility
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
