Multisensor Wireless Pressure Microcatheter For Microvascular Function Assessment In ANOCA/INOCA Patients: A Prospective, Multicenter, Single-Group Target Value Study

NCT07453381 | Not Yet Recruiting

• 1 other identifier: M20251062
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Coronary Microvascular Dysfunction (CMD)

Keywords

Pressure Microcatheter; Microvascular Function Assessment; Angina with Non-obstructive Coronary Arteries; Ischaemia with Non-obstructive Coronary Arteries; Coronary Microvascular Dysfunction

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of multi-sensor wireless pressure microcatheter for calculating Coronary Flow Reserve (CFR) in diagnosing Coronary Microvascular Dysfunction (CMD)

  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.

  Intraoperative period (day 0) and post-operative (days 1-7)

Secondary Outcomes (5)

• Multi-sensor wireless pressure microcatheter calculation of CFR for diagnosing CMD: accuracy, positive predictive value, negative predictive value, Receiver Operating Characteristic Curve (ROC), and Area Under the Curve（AUC）

  Intraoperative period (day 0) and post-operative (days 1-7)

• Pearson correlation analysis and Bland-Altman bias analysis of CFR calculated by multi-sensor wireless pressure microcatheter and MPR calculated by CMR quantitative myocardial perfusion imaging.

  Intraoperative period (day 0) and post-operative (days 1-7)

• Pearson correlation analysis of multi-sensor wireless pressure microcatheter measurements of Tmn,rest and Tmn,hyper with CMR quantitative myocardial perfusion imaging measurements of MBFrest and MBFhyper.

  Intraoperative period (day 0) and post-operative (days 1-7)

• Multi-sensor wireless pressure microcatheter calculation of Index of Microcirculatory Resistance (IMR) for diagnosing CMD: accuracy, sensitivity, specificity, positive predictive value, negative predictive value, ROC, and AUC.

  Intraoperative period (day 0) and post-operative (days 1-7)

• Multi-sensor wireless pressure microcatheter calculation of Microvascular Resistance Reserve (MRR) for diagnosing CMD: accuracy, sensitivity, specificity, positive predictive value, negative predictive value, ROC, and AUC.

  Intraoperative period (day 0) and post-operative (days 1-7)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (3)

Wang Jing Hospital Of CACMS（China Academy of Chinese Medical Sciences）

Beijing, Beijing Municipality, 100102, China

Location

Cangzhou Central Hospital

Cangzhou, Hebei, China

Location

Chengdu Second People's Hospital

Chengdu, Sichuan, China

Location

Central Study Contacts

Ming Cui

CONTACT

010-82266699; mingcui@bjmu.edu.cn

Ruitao Zhang

CONTACT

010-82266699; clinicboy@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2026
• First Posted: March 6, 2026
• Study Start: March 23, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-02

Locations

CN (3)