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Additive Value of Physiology Coronary in Clinical Practice

Additive Value of Physiology Coronary in Clinical Practice

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04560829
Acronym
PRINCIPE
Enrollment
150
Registered
2020-09-23
Start date
2021-09-13
Completion date
2023-05-31
Last updated
2022-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microvascular Coronary Artery Disease

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.

Interventions

None listed

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frame
Rate of CMVD defined by microcirculatory resistance index (IMR) > 25At inclusion

Secondary

MeasureTime frameDescription
Correlation between coronary physiology parameters and imaging dataAt inclusionCoronary angiography and coronary physiology parameters:% of epicardial stenosis, FFR, CFR, IMR
Assessment of the symptoms of angina pectoris12 monthsBrief angina questionnaire
Prevalence of macro and microvascular anginaAt inclusionMacro and microvascular angina rate according to international angiographic diagnostic criteria
Evaluate medical consumption12 monthsNumber of medical consultation
Evaluation of serious cardiovascular event rate12 monthsCardiovascular event
Compare the rate of peri-procedural myocardial distressAt inclusionPost PCI troponin rate

Countries

France

Contacts

Primary ContactGilles Barone Rochette, MD PhD
gbarone@chu-grenoble.fr+33476768888
Backup ContactClemence Charlon, MSc
ccharlon@chu-grenoble.fr+33476766652

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026