Multisensor Wireless Pressure Microcatheter For Microvascular Function Assessment In ANOCA/INOCA Patients: A Prospective, Multicenter, Single-Group Target Value Study
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Age ≥ 18 years, gender not limited;
2. Symptoms of angina pectoris, or objective evidence of myocardial ischemia (e.g., electrocardiogram, myocardial injury markers, etc.);
3. Visual assessment of coronary angiography shows diameter stenosis \< 50% and FFR \> 0.8 (or cRR \> 0.89);
4. Microvascular function assessment is planned;
5. Agree to participate in this clinical study and voluntarily sign the informed consent form.
Exclusion Criteria:
1. Acute myocardial infarction, PCI, CABG, or valvular surgery following angiography within the past 30 days;
2. Severe valvular disease requiring surgical or interventional treatment;
3. Chest pain with known non-ischemic causes (e.g., pericarditis, pulmonary hypertension, esophageal spasm);
4. Contraindications to CMR (e.g., certain types of pacemakers or defibrillators, severe claustrophobia);
5. 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);
6. Renal insufficiency (eGFR ≤ 45 mL/min/1.73 m2) or currently undergoing dialysis;
7. Severe heart failure or LVEF ≤ 35%;
8. Severe organ disease or life expectancy less than 2 years;
9. Known to be participating in other drug or device clinical trials that have not yet met the primary endpoint;
10. Other investigators deem the candidate unsuitable for this clinical trial.
Primary outcome measure(s)
Sensitivity and specificity of multi-sensor wireless pressure microcatheter for calculating Coronary Flow Reserve (CFR) in diagnosing Coronary Microvascular Dysfunction (CMD) — 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.
Trial sites (5)
Facility
City
Region
Status
Wang Jing Hospital Of CACMS(China Academy of Chinese Medical Sciences)
Beijing
Beijing Municipality
Not Yet Recruiting
Cangzhou Central Hospital
Cangzhou
Hebei
Not Yet Recruiting
Chengdu Second People's Hospital
Chengdu
Sichuan
Not Yet Recruiting
Beijing Anzhen Hospital.Capital Medical University
Beijing
China
Recruiting
Peking University Third Hospital
Beijing
China
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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