Multisensor Wireless Pressure Microcatheter For Microvascular Function Assessment In ANOCA/INOCA … (NCT07453381) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Multisensor Wireless Pressure Microcatheter For Microvascular Function Assessment In ANOCA/INOCA Patients: A Prospective, Multicenter, Single-Group Target Value Study
China114 participantsStarted 2026-03-23
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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%;
What they're measuring
1
Sensitivity and specificity of multi-sensor wireless pressure microcatheter for calculating Coronary Flow Reserve (CFR) in diagnosing Coronary Microvascular Dysfunction (CMD)
Timeframe: Intraoperative period (day 0) and post-operative (days 1-7)