Coronary Microvascular Dysfunction (CMD)
Conditions
Keywords
Pressure Microcatheter, Microvascular Function Assessment, Angina with Non-obstructive Coronary Arteries, Ischaemia with Non-obstructive Coronary Arteries, Coronary Microvascular Dysfunction
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.
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).
Interventions
None listed
Sponsors
Peking University Third Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and specificity of multi-sensor wireless pressure microcatheter for calculating Coronary Flow Reserve (CFR) in diagnosing Coronary Microvascular Dysfunction (CMD) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
| 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) | 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. |
| 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) | 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. |
| 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) | 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. |
| 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) | 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. |
Countries
China
Contacts
CONTACTMing Cui
CONTACTRuitao Zhang
Outcome results
None listed