Additive Value of Physiology Coronary in Clinical Practice

NCT04560829 | Unknown

• 2 other identifiers: 38RC20.2942020-A02325-34
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Microvascular Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Rate of CMVD defined by microcirculatory resistance index (IMR) > 25

  At inclusion

Secondary Outcomes (11)

• Prevalence of macro and microvascular angina

  At inclusion

• Correlation between coronary physiology parameters and imaging data

  At inclusion

• Correlation between coronary physiology parameters and imaging data

  At inclusion

• Correlation between coronary physiology parameters and imaging data

  At inclusion

• Correlation between coronary physiology parameters and imaging data

  At inclusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

Grenoble University Hospital

La Tronche, 38700, France

RECRUITING

Central Study Contacts

Gilles Barone Rochette, MD PhD

CONTACT

+33476768888; gbarone@chu-grenoble.fr

Clemence Charlon, MSc

CONTACT

+33476766652; ccharlon@chu-grenoble.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: September 23, 2020
• Study Start: September 13, 2021
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: May 25, 2022

Record last verified: 2022-05

Locations

FR (1)