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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.
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).
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| 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) |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming Cui | Contact | 010-82266699 | mingcui@bjmu.edu.cn | |
| Ruitao Zhang | Contact | 010-82266699 | clinicboy@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wang Jing Hospital Of CACMS（China Academy of Chinese Medical Sciences） | Beijing | Beijing Municipality | 100102 | China |
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| 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) |
| Cangzhou Central Hospital | Cangzhou | Hebei | China |
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| Chengdu Second People's Hospital | Chengdu | Sichuan | China |
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