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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Microvascular Dysfunction (CMD)

Detailed Description

This is a prospective, multicenter, single-group target value study, which 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).

• Study Type: Observational
• Enrollment (Estimated): 114

Contacts and Locations

• Study Contact: Name: Ming Cui; Phone Number: 010-82266699; Email: mingcui@bjmu.edu.cn
• Study Contact Backup: Name: Ruitao Zhang; Phone Number: 010-82266699; Email: clinicboy@126.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100102
      • Wang Jing Hospital Of CACMS（China Academy of Chinese Medical Sciences）
      • Contact: Xiaojie chen; Phone Number: 010-84739047; Email: 13810245800@163.com
  • Hebei
    • Cangzhou, Hebei, China
      • Cangzhou Central Hospital
      • Contact: Jun Zhang; Phone Number: 0317-2075736; Email: dr_zhangj@sina.com
  • Sichuan
    • Chengdu, Sichuan, China
      • Chengdu Second People's Hospital
      • Contact: Jianxiong Liu; Phone Number: 028-67830010; Email: steven.ljx@vip.163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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).

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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）	Using study participants as the unit of study, and with MPR calculated by CMR quantitative myocardial perfusion imaging as a reference (MPR<2.2 as positive, MPR≥2.2 as negative), the accuracy, positive predictive value, negative predictive value, ROC, and AUC of CFR calculated by multi-sensor wireless pressure microcatheter for diagnosing CMD (CFR<2.5 as positive, CFR≥2.5 as negative) were evaluated.	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.	Using blood vessels as the research unit, Pearson correlation analysis and Bland-Altman bias analysis were performed on the CFR calculated by multi-sensor wireless pressure microcatheter and the 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.	Using blood vessels as the unit of study, Pearson correlation analysis was performed on the Mean Transit Time in the resting state (Tmn,rest) and the Mean Transit Time in the hyperemia state (Tmn,hyper) measured by multi-sensor wireless pressure microcatheter,Myocardial Blood Flow in the resting state (MBFrest) and Myocardial Blood Flow in the hyperemia state (MBFhyper) by CMR quantitative myocardial perfusion imaging,respectively.	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.	Using study participants as the unit of study, and with MPR calculated by CMR quantitative myocardial perfusion imaging as a reference (MPR<2.2 as positive, MPR≥2.2 as negative), the accuracy, sensitivity, specificity, positive predictive value, negative predictive value, ROC, and AUC of IMR calculated by multi-sensor wireless pressure microcatheter for the diagnosis of CMD (IMR<25 as negative, IMR≥25 as positive) were evaluated.	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.	Using study participants as the unit of study, and with MPR calculated by CMR quantitative myocardial perfusion imaging as a reference (MPR<2.2 is positive, MPR≥2.2 is negative), the accuracy, sensitivity, specificity, positive predictive value, negative predictive value, ROC, and AUC of MRR calculated by multi-sensor wireless pressure microcatheter for the diagnosis of CMD (MRR<2.1 is positive, MRR≥2.1 is negative) were evaluated.	Intraoperative period (day 0) and post-operative (days 1-7)

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 23, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: March 1, 2026
• First Submitted That Met QC Criteria: March 1, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 1, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Coronary Microvascular Dysfunction; Pressure Microcatheter; Microvascular Function Assessment; Angina with Non-obstructive Coronary Arteries; Ischaemia with Non-obstructive Coronary Arteries
• Other Study ID Numbers: M20251062

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No