Multisensor Wireless Pressure Microcatheter For Microvascular Function Assessment In ANOCA/INOCA Patients: A Prospective, Multicenter, Single-Group Target Value Study
Recruiting
Observational Study
Coronary Microvascular Dysfunction (CMD)
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
114 (estimated)
Sponsor
Peking University Third Hospital · Other
Who this trial is looking for
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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.
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Eligibility Criteria
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…
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.
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