Trials / Completed
CompletedNCT05009667
A Prospective, Multi-center Clinical Trial for Evaluating the Effectiveness and Safety of Online Coronary Angiography-Derived Index of Microcirculatory Resistance (caIMR)
A Prospective, Multi-center Clinical Trial for Evaluating the Effectiveness and Safety of Coronary Angiography-Derived Index of Microcirculatory Resistance Measured Online by a Coronary Functional Measurement System
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 116 (actual)
- Sponsor
- Ge Junbo · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
More than 50% of patients with stable or unstable angina pectoris have no obstructive coronary arteries by angiographic visual estimation, in which coronary microvascular dysfunction (CMD) is one of the causes of myocardial ischemia and chest pain. A coronary angiography-derived index of microcirculatory resistance (caIMR) is proposed for physiological assessment of microvascular diseases in coronary circulation. The aim of the trial is to assess diagnostic performance of caIMR, using wire-derived index of microcirculatory resistance (IMR) as the reference standard.
Detailed description
More than 50% of patients with stable or unstable angina pectoris have no obstructive coronary arteries by angiographic visual estimation, in which coronary microvascular dysfunction (CMD) is one of the causes of myocardial ischemia and chest pain. Presently, the index of microcirculatory resistance (IMR) measured by the pressure wire is recognized as standard for evaluating coronary microcirculatory function. A coronary angiography-derived index of microcirculatory resistance (caIMR) is proposed for physiological assessment of microvascular diseases in coronary circulation without pressure wire, hyperemic agents, or thermodilution method. This study is a prospective, multi-center clinical trial. In the study, IMR (measured by pressure wire) will be used as a reference standard to evaluate the feasibility, accuracy and safety of caIMR measured by a non-invasive diagnosis system (FM21a) based on angiography images and aortic pressure wave. 116 patients eligible for inclusion criteria will be enrolled in the study. Both IMR and caIMR measurement will be performed in the same patient in a random order after angiography. The definitions of IMR and caIMR for coronary microcirculatory ischemia are IMR≥25 and caIMR≥25. The primary endpoint is the diagnostic accuracy of caIMR. The secondary endpoint is caIMR's sensitivity, specificity, positive predictive value, negative predictive value, ROC curve and AUC of caIMR diagnosis, and the diagnostic characteristics of caIMR at the vascular level.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Angiography-derived Index of Microcirculatory Resistance | caIMR will be measured by pressure sensors which are produced by Suzhou Rainmed Medical Technology Co., Ltd. caIMR is calculated based on angiography images and Hyperemic Pa estimated from resting Pa according to prespecified equation. |
| DEVICE | Pressure wire-based Index of Microcirculatory Resistance | IMR will be measured by thermodilution method with pressure wire and arterial physiological detector which are produced by St. Jude Medical. IMR = Pd ∙Tmn |
Timeline
- Start date
- 2021-10-14
- Primary completion
- 2021-12-31
- Completion
- 2021-12-31
- First posted
- 2021-08-17
- Last updated
- 2022-04-06
Locations
3 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05009667. Inclusion in this directory is not an endorsement.