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

July 29, 2026 updated by: Peking University Third Hospital
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
114

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking University Third Hospital
        • Contact:
        • Contact:
      • Beijing, China
        • Recruiting
        • Beijing Anzhen Hospital.Capital Medical University
        • Contact:
        • Contact:
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100102
        • Not yet recruiting
        • Wang Jing Hospital Of CACMS（China Academy of Chinese Medical Sciences）
        • Contact:
    • Hebei
      • Cangzhou, Hebei, China
        • Not yet recruiting
        • Cangzhou Central Hospital
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China
        • Not yet recruiting
        • Chengdu second people's hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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)
Time Frame: 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.
Intraoperative period (day 0) and post-operative (days 1-7)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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）
Time Frame: Intraoperative period (day 0) and post-operative (days 1-7)
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.
Time Frame: Intraoperative period (day 0) and post-operative (days 1-7)
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.
Time Frame: Intraoperative period (day 0) and post-operative (days 1-7)
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.
Time Frame: Intraoperative period (day 0) and post-operative (days 1-7)
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.
Time Frame: Intraoperative period (day 0) and post-operative (days 1-7)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 30, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 1, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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