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

Multimodal Epicardial and Endocardial COronary PHYsiological Evaluation in Pathological Situations

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease; Coronary Microvascular Dysfunction

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

Study Locations

• France
  • Brest, France, 29609
    • CHU Brest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

Inclusion Criteria:

• Intermediate coronary lesion (between 50 and 70%)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Index of Microcirculatory Resistance (IMR)	IMR = Pd x Tmn at maximal hyperhemia Normal range < 25	During coronary angiography

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death		12 months
Fractional Flow Reserve (FFR)	FFR = Pd/Pa at maximal hyperhemia Normal value > 0.80	During coronary angiography
Coronary Flow Reserve (CFR)	CFR = Hyperhemic flow / Resting flow Normal value > 2	During coronary angiography
Resting Full cycle Ratio (RFR)	Lowest Pd/Pa value in systole and diastole (mean of 5 consecutive cardiac cycles) Normal value > 0.80	During coronary angiography
Quantitative Flow Ratio (QFR)	Normal value > 0.80	During coronary angiography
Angio-IMR	Estimated hyperemic Pa × angio-FFR × [vessel length/(K × Vdiastole)] Normal value < 25	During coronary angiography
Angina pectoris (CCS)	Grade I : Angina with strenuous or rapid or prolonged exertion at work or recreation Grade II : Slight limitation of ordinary activity Grade III : Marked limitation of ordinary physical activity Grade IV : Inability to carry on any physical activity without discomfort, anginal syndrome may be present at rest	12 months

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2023
• Primary Completion (Actual): July 13, 2023
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: August 16, 2023
• First Submitted That Met QC Criteria: August 16, 2023
• First Posted (Actual): August 23, 2023

Study Record Updates

• Last Update Posted (Actual): August 28, 2023
• Last Update Submitted That Met QC Criteria: August 24, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Coronary Physiology; Index of Microcirculatory Resistance (IMR)
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 29BRC23.0037 - PHYCO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No