Coronary Microvascular Dysfunction (CMD)NCT07453381
Multisensor Wireless Pressure Microcatheter For Microvascular Function Assessment In ANOCA/INOCA Patients: A Prospective, Multicenter, Single-Group Target Value Study
An observational study of Coronary Microvascular Dysfunction (CMD), run by Peking University Third Hospital at 5 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Microvascular Dysfunction (CMD)
- How many people
- 114 participants
- Where
- 5 sitesChina
- Study dates
- 30 Jun 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Not yet recruiting
Wang Jing Hospital Of CACMS（China Academy of Chinese Medical Sciences）
Beijing, Beijing Municipality, 100102
Xiaojie chen, 010-84739047, 13810245800@163.com
- Recruiting
Beijing Anzhen Hospital.Capital Medical University
Beijing
Lei Xu, 010-64412431, leixu2001@aliyun.com
Kairui Bo, 010-64412431, bo20200@126.com
- Recruiting
Peking University Third Hospital
Beijing
Ming Cui, 010-82266699, mingcui@bjmu.edu.cn
Ruitao Zhang, 010-82266699, clinicboy@126.com
- Not yet recruiting
Cangzhou Central Hospital
Cangzhou, Hebei
Jun Zhang, 0317-2075736, dr_zhangj@sina.com
- Not yet recruiting
Chengdu Second People's Hospital
Chengdu, Sichuan
Jianxiong Liu, 028-67830010, steven.ljx@vip.163.com
About this 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.
Read the 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).
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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）
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Intraoperative period (day 0) and post-operative (days 1-7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start30 Jun 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Microvascular Dysfunction (CMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07453381
- Sponsor's protocol ID
- M20251062
- Status last verified
- Jul 2026
- First submitted
- 1 Mar 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multisensor Wireless Pressure Microcatheter For Microvascular Function Assessment In ANOCA/INOCA Patients: A Prospective, Multicenter, Single-Group Target Value Study
- ClinicalTrials.gov ID
- NCT07453381
- Acronym / sponsor ID
- M20251062
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 30 Jun 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
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)
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)
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)
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Microvascular Dysfunction (CMD), run by Peking University Third Hospital at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ming Cui (010-82266699, mingcui@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.