Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms

  • Coronary Microvascular Dysfunction

NCT number NCT05009667
Study type Observational
Source Fudan University
Contact
Status Completed
Phase
Start date October 14, 2021
Completion date December 31, 2021

See also
  Status Clinical Trial Phase
Completed NCT06306066 - Coronary Thermo-dilution Derived Flow-indices in Chronic Coronary Syndrome
Recruiting NCT05288361 - The DISCOVER INOCA Prospective Multi-center Registry
Terminated NCT04614467 - A Placebo-Controlled Trial of CLBS16 in Subjects With Coronary Microvascular Dysfunction Phase 2
Recruiting NCT06089031 - Belgian Registry on Coronary Function Testing
Enrolling by invitation NCT06083155 - The NetherLands Registry of Invasive Coronary Vasomotor Function Testing (NL-CFT)
Active, not recruiting NCT05197361 - Microvascular Coronary Resistance and Absolute Coronary FLOW in Patients With Percutaneous Intervention of a Chronic Total Occlusion
Not yet recruiting NCT06332131 - Effects of Immune Checkpoint Inhibitors on Coronary Microvasculature
Recruiting NCT05825339 - Absolute Flow for Ischemia With No Obstructive Coronary Arteries
Recruiting NCT05294887 - Randomized Trial to Examine a Differential Therapeutic Response in Symptomatic Patients With Non-obstructive Coronary Artery Disease Phase 4
Not yet recruiting NCT05790876 - Super Saturated Oxygen (SSO2) Therapy in Patients With ST-segment Elevation Myocardial Infarction (STEMI) and Action on Coronary Microcirculation Dysfunction N/A
Completed NCT04959357 - The Evaluation of Left Ventricular Systolic Function in Different Types of Ischemic Heart Disease
Recruiting NCT06393478 - Southeastern Europe Microcirculation Registry
Completed NCT04523168 - Feasibility and Efficacy of Coronary Sinus Narrowing in Patients With Coronary Microvascular Dysfunction N/A
Recruiting NCT05711719 - Vericiguat in Patients With Metabolic Syndrome and Coronary Vascular Dysfunction Phase 2
Recruiting NCT06294730 - COronary Microcirculation and Troponin Elevation in Septic Shock
Recruiting NCT05841485 - COVID-19 Microvascular Evaluation Trial
Recruiting NCT03876223 - Women's Ischemia Syndrome Evaluation (WISE) Pre-HFpEF
Completed NCT05471739 - Simultaneous Assessment of Coronary Microvascular Dysfunction and Ischemia With Non-obstructed Coronary Arteries With Intracoronary Electrocardiogram and Intracoronary Doppler
Completed NCT02333591 - Effect of Intact GLP-1 (7-36) and GLP-1 Metabolite (9-36) on Coronary and Peripheral Vascular Function in Adults Phase 4
Completed NCT01014949 - Microcirculation Assessment in Diabetes and Metabolic Syndrome N/A