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Clinical Trials/NCT04560829
NCT04560829
Unknown
Not Applicable

Additive Value of Physiology Coronary in Clinical Practice

University Hospital, Grenoble1 site in 1 country150 target enrollmentSeptember 13, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Microvascular Coronary Artery Disease
Sponsor
University Hospital, Grenoble
Enrollment
150
Locations
1
Primary Endpoint
Rate of CMVD defined by microcirculatory resistance index (IMR) > 25
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 13, 2021
End Date
May 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Grenoble
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

Time Frame: At inclusion

Secondary Outcomes

  • Assessment of the symptoms of angina pectoris(12 months)
  • Compare the rate of peri-procedural myocardial distress(At inclusion)
  • Evaluate medical consumption(12 months)
  • Prevalence of macro and microvascular angina(At inclusion)
  • Correlation between coronary physiology parameters and imaging data(At inclusion)
  • Evaluation of serious cardiovascular event rate(12 months)

Study Sites (1)

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