Clinical trial NCT04560829: Additive Value of Physiology Coronary in Clinical Practice
Official title: Additive Value of Physiology Coronary in Clinical Practice
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Microvascular Coronary Artery Disease
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2020-09-23
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient undergoing coronary artery assessment. Patients will be included in the study prospectively during the assessment with collection of the patient's non-objection during follow-ups.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of CMVD defined by microcirculatory resistance index (IMR) > 25
timeFrame: At inclusion
Secondary outcomes:
measure: Prevalence of macro and microvascular angina
timeFrame: At inclusion
measure: Correlation between coronary physiology parameters and imaging data
timeFrame: At inclusion
measure: Correlation between coronary physiology parameters and imaging data
timeFrame: At inclusion
measure: Correlation between coronary physiology parameters and imaging data
timeFrame: At inclusion
measure: Correlation between coronary physiology parameters and imaging data
timeFrame: At inclusion
measure: Correlation between coronary physiology parameters and imaging data
timeFrame: At inclusion
measure: Correlation between coronary physiology parameters and imaging data
timeFrame: At inclusion
measure: Assessment of the symptoms of angina pectoris
timeFrame: 12 months
measure: Compare the rate of peri-procedural myocardial distress
timeFrame: At inclusion
measure: Evaluate medical consumption
timeFrame: 12 months
measure: Evaluation of serious cardiovascular event rate
timeFrame: 12 months
Other outcomes:
Locations:
city: La Tronche
country: France
facility: Grenoble University Hospital
Study officials:
References: