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

Active, not recruiting

• Conditions: Coronary Artery Disease; Coronary Microvascular Dysfunction

• Registration Number: NCT06008041
• Lead Sponsor: University Hospital, Brest

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-13
• Primary Completion: 2023-07-13
• Status Verified: 2023-08
• Study First Submitted: 2023-08-16
• Study First Submitted QC: 2023-08-16
• Study First Posted: 2023-08-23
• Last Update Submitted: 2023-08-24
• Last Update Posted: 2023-08-28
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Index of Microcirculatory Resistance (IMR)	During coronary angiography	IMR = Pd x Tmn at maximal hyperhemia Normal range \< 25

Secondary Outcome Measures

Name	Time	Method
Death	12 months
Quantitative Flow Ratio (QFR)	During coronary angiography	Normal value \> 0.80
Fractional Flow Reserve (FFR)	During coronary angiography	FFR = Pd/Pa at maximal hyperhemia Normal value \> 0.80
Resting Full cycle Ratio (RFR)	During coronary angiography	Lowest Pd/Pa value in systole and diastole (mean of 5 consecutive cardiac cycles) Normal value \> 0.80
Coronary Flow Reserve (CFR)	During coronary angiography	CFR = Hyperhemic flow / Resting flow Normal value \> 2
Angio-IMR	During coronary angiography	Estimated hyperemic Pa × angio-FFR × \[vessel length/(K × Vdiastole)\] Normal value \< 25
Angina pectoris (CCS)	12 months	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

Trial Locations

Locations (1)

Chu Brest; 🇫🇷 Brest, France