Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04560829
Other study ID # 38RC20.294
Secondary ID 2020-A02325-34
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Withdrawn NCT04069234 - Study in Diabetes Mellitus Patients Without Prior Myocardial Infarction or Stroke Undergoing Elective Percutaneous Coronary Intervention. Phase 3
Recruiting NCT06080919 - Plaque Modification And Impact On Microcirculatory Territory After Drug-Coated Balloon Percutaneous Coronary Intervention (PLAMI). N/A
Terminated NCT04614467 - A Placebo-Controlled Trial of CLBS16 in Subjects With Coronary Microvascular Dysfunction Phase 2
Terminated NCT03236311 - A Dose Titration Study to Assess the Effects of SAR407899 in Patients With MVA and/or Persistent Stable Angina Despite Angiographically Successful PCI Phase 2
Recruiting NCT04541797 - Stress Cardiac Magnetic Resonance of Asymptomatic Type 2 Diabetics With Cardiovascular High Risk to Measure Empagliflozin Impact on Myocardial Blood Flow (CATCH-EM) N/A
Recruiting NCT04598308 - EUROpean Coronary microCirculatory Resistance and Absolute Flow Trial
Active, not recruiting NCT05197361 - Microvascular Coronary Resistance and Absolute Coronary FLOW in Patients With Percutaneous Intervention of a Chronic Total Occlusion
Recruiting NCT04827498 - Myocardial Ischemia Without Obstructive Coronary Stenoses
Suspended NCT05756088 - Determining the Association of Microvascular Disease as Assessed by PET and Graft Injury by Donor Derived Cell Free DNA
Recruiting NCT06118450 - Clinical Trial for Evaluating the Effectiveness and Safety of Online caIMR in STEMI Patients
Recruiting NCT03217227 - Evaluating Myocardial Ischemia in Chest Pain Using Exercise CMR
Completed NCT03462017 - Pharmacodynamic Study to Assess the Effects of Repeated Dosing of SAR247799 on Endothelial Function in Patients With Type 2 Diabetes Mellitus Phase 1
Not yet recruiting NCT06269874 - Study Comparing Two Administration Pathways for Adenosine During Microvascular Function Assessment N/A
Not yet recruiting NCT06217120 - Reversing Microvascular Dysfunction in Heart Failure With Preserved Ejection Fraction Phase 2/Phase 3
Recruiting NCT06316661 - CMR Assessment of Cardiac Microvascular Dysfunction in Patients With HFpEF
Recruiting NCT04131075 - The Cerebral-Coronary Connection (C3) Study
Completed NCT04485234 - Inclusive Invasive Physiological Assessment in Angina Syndromes Registry
Completed NCT05471739 - Simultaneous Assessment of Coronary Microvascular Dysfunction and Ischemia With Non-obstructed Coronary Arteries With Intracoronary Electrocardiogram and Intracoronary Doppler
Completed NCT05406297 - Impact of TMAO Serum Levels on Hyperemic IMR in STEMI Patients
Not yet recruiting NCT06069401 - The MASTER-PACT Study