Multi-sensor wireless pressure catheter to test microvascular function in people with angina and non-obstructive arteries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter, single-group study aiming to determine how sensitive and specific a novel multisensor wireless pressure microcatheter is for diagnosing coronary microvascular dysfunction. Participants are adults with angina or objective ischemia and with minimal visual disease on angiography (diameter stenosis <50% and FFR >0.8 or cRR >0.89). The study uses quantitative myocardial perfusion imaging from cardiac MRI as the reference standard. Enrollment is across three Chinese centers, with a target-value design to establish diagnostic performance for CMD assessment during planned microvascular function testing. No interventions are described beyond the diagnostic procedure itself.

Why it matters

Who can join: the full rules

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.

Where it's running

• Beijing Anzhen Hospital.Capital Medical University
  Beijing, China Recruiting
• Peking University Third Hospital
  Beijing, China Recruiting
• Wang Jing Hospital Of CACMS（China Academy of Chinese Medical Sciences）
  Beijing, Beijing Municipality, China Not yet recruiting
• Cangzhou Central Hospital
  Cangzhou, Hebei, China Not yet recruiting
• Chengdu Second People's Hospital
  Chengdu, Sichuan, China Not yet recruiting

Study contacts

• Study coordinator: Ming Cui
• Email: mingcui@bjmu.edu.cn
• Phone: 010-82266699

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.