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

Coronary Artery Disease Clinical Trial

— PHYCO  

Official title:

Multimodal Epicardial and Endocardial COronary PHYsiological Evaluation in Pathological Situations

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06008041
• Other study ID #: 29BRC23.0037 - PHYCO
• Status: Active, not recruiting
• Start date: July 13, 2023
• Est. completion date: April 1, 2027

Study information

• Verified date: August 2023
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: April 1, 2027
• Est. primary completion date: July 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Microvascular Dysfunction
• Myocardial Ischemia

Locations

Country	Name	City	State
France	Chu Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Index of Microcirculatory Resistance (IMR)	IMR = Pd x Tmn at maximal hyperhemia Normal range < 25	During coronary angiography
Secondary	Fractional Flow Reserve (FFR)	FFR = Pd/Pa at maximal hyperhemia Normal value > 0.80	During coronary angiography
Secondary	Coronary Flow Reserve (CFR)	CFR = Hyperhemic flow / Resting flow Normal value > 2	During coronary angiography
Secondary	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
Secondary	Quantitative Flow Ratio (QFR)	Normal value > 0.80	During coronary angiography
Secondary	Angio-IMR	Estimated hyperemic Pa × angio-FFR × [vessel length/(K × Vdiastole)] Normal value < 25	During coronary angiography
Secondary	Death		12 months
Secondary	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