Multimodal Epicardial and Endocardial COronary PHYsiological Evaluation in Pathological Situations (PHYCO)

NCT06008041 | Active Not Recruiting

• 1 other identifier: 29BRC23.0037 - PHYCO
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

When performing coronary angiography in a stable situation, the identification of an intermediate coronary lesion (between 50 and 70%) is common, and requires additional functional evaluation. The gold standard for this evaluation is Fractional Flow Reserve (FFR). FFR is a flow ratio transformed into a pressure ratio by simplification, neglecting some parameters, especially microcirculatory resistance. The aim of this study is to investigate hemodynamic and structural assessment induced in specific conditions, and their repercussion on functional assessment by FFR to implement the diagnostic approach and personalize it for each patient.

Conditions

Coronary Artery Disease; Coronary Microvascular Dysfunction

Keywords

Coronary Artery Disease; Coronary Physiology; Index of Microcirculatory Resistance (IMR)

Outcome Measures

Primary Outcomes (1)

• Index of Microcirculatory Resistance (IMR)

  IMR = Pd x Tmn at maximal hyperhemia Normal range \< 25

  During coronary angiography

Secondary Outcomes (7)

• Fractional Flow Reserve (FFR)

  During coronary angiography

• Coronary Flow Reserve (CFR)

  During coronary angiography

• Resting Full cycle Ratio (RFR)

  During coronary angiography

• Quantitative Flow Ratio (QFR)

  During coronary angiography

• Angio-IMR

  During coronary angiography

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

* Diabetes mellitus * High blood pressure * Aortic stenosis * Hypertrophic cardiopathy * Dilated cardiopathy * Stress cardiopathy * Elderly people \> 75 years old * Acute coronary syndrome * Preserved heart failure * Cardiac amyloidosis

You may qualify if:

• Intermediate coronary lesion (between 50 and 70%)

You may not qualify if:

• Hemodynamic instability
• Adenosine hypersensitivity
• Asthma
• Severe chronic obstructive pulmonary disease
• Long QTc
• Wolff parkinson white
• High degree atriovenricular block
• Left-right shunt
• Carotid artery stenosis with hemodynamic insufficiency
• Pregnancy

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

Chu Brest

Brest, 29609, France

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

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

Study Record Dates

• First Submitted: August 16, 2023
• First Posted: August 23, 2023
• Study Start: July 13, 2023
• Primary Completion: July 13, 2023
• Study Completion (Estimated): April 1, 2027
• Last Updated: August 28, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations

FR (1)