Additive Value of Physiology Coronary in Clinical Practice

Microvascular Coronary Artery Disease Clinical Trial

— PRINCIPE  

Official title:

Additive Value of Physiology Coronary in Clinical Practice

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04560829
• Other study ID #: 38RC20.294
• Secondary ID: 2020-A02325-34
• Status: Recruiting
• Start date: September 13, 2021
• Est. completion date: May 2023

Study information

• Verified date: May 2022
• Source: University Hospital, Grenoble
• Contact: Gilles Barone Rochette, MD PhD
• Phone: +33476768888
• Email: gbarone[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 2023
• Est. primary completion date: May 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Microvascular Coronary Artery Disease

Locations

Country	Name	City	State
France	Grenoble University Hospital	La Tronche

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of CMVD defined by microcirculatory resistance index (IMR) > 25		At inclusion
Secondary	Prevalence of macro and microvascular angina	Macro and microvascular angina rate according to international angiographic diagnostic criteria	At inclusion
Secondary	Correlation between coronary physiology parameters and imaging data	Coronary angiography and coronary physiology parameters:% of epicardial stenosis, FFR, CFR, IMR	At inclusion
Secondary	Correlation between coronary physiology parameters and imaging data	SPEC parameters	At inclusion
Secondary	Correlation between coronary physiology parameters and imaging data	Cardiac echography parameters	At inclusion
Secondary	Correlation between coronary physiology parameters and imaging data	Stress cardiac echography parameters	At inclusion
Secondary	Correlation between coronary physiology parameters and imaging data	MRI parameters	At inclusion
Secondary	Correlation between coronary physiology parameters and imaging data	Cardiac CT parameters	At inclusion
Secondary	Assessment of the symptoms of angina pectoris	Brief angina questionnaire	12 months
Secondary	Compare the rate of peri-procedural myocardial distress	Post PCI troponin rate	At inclusion
Secondary	Evaluate medical consumption	Number of medical consultation	12 months
Secondary	Evaluation of serious cardiovascular event rate	Cardiovascular event	12 months