Additive Value of Physiology Coronary in Clinical Practice

• Conditions: Microvascular Coronary Artery Disease

• Registration Number: NCT04560829
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

The important evidence of coronary microcirculation for the management of patients with coronary artery disease is only increasing. Thus, in recent years, a number of studies have shown that the demonstration of coronary microvascular disease (CMVD) contributes to cardiovascular morbidity and mortality increases independently of epicardial damage. This has been shown in stable coronary artery disease with screening for CMVD when there is no significant epicardial involvement and allowing the implementation of an adapted treatment then reducing the symptoms and improving the quality of life of our patients. (1). The prognostic nature of CMVD has also been identified in stable disease after coronary angioplasty (2) but also in patients with infarcts reperfused by coronary angioplasty (3).

The complete exploration of the epicardial and microvascular coronary vascularization is grouped under the name of the subspecialty: coronary physiology. Thus, an internationally recognized algorithm for exploring coronary physiology has been published (4).

However, this algorithm is still little followed. The PRINCIPE registry aims to assess the prevalence of CMVD with the use of a standardized algorithm for exploring coronary physiology by coronary angiography in our center in current practice.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-17
• Study First Submitted QC: 2020-09-17
• Study First Posted: 2020-09-23
• Study Start: 2021-09-13
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-18
• Last Update Posted: 2022-05-25
• Primary Completion: 2023-05
• Study Completion: 2023-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Male or female patients over 18 years of age
• Having a coronary angiography
• Presenting in pain or having performed a positive ischemia test
• Affiliated with social security
• Non-opposition to participation

Exclusion Criteria

• Adult patient protected by law (article L1121-8)
• Person deprived of liberty (article L1121-8)
• Pregnant woman

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of CMVD defined by microcirculatory resistance index (IMR) > 25	At inclusion

Secondary Outcome Measures

Name	Time	Method
Assessment of the symptoms of angina pectoris	12 months	Brief angina questionnaire
Compare the rate of peri-procedural myocardial distress	At inclusion	Post PCI troponin rate
Evaluate medical consumption	12 months	Number of medical consultation
Prevalence of macro and microvascular angina	At inclusion	Macro and microvascular angina rate according to international angiographic diagnostic criteria
Correlation between coronary physiology parameters and imaging data	At inclusion	Cardiac CT parameters
Evaluation of serious cardiovascular event rate	12 months	Cardiovascular event

Trial Locations

Locations (1)

Grenoble University Hospital; 🇫🇷 La Tronche, France