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

Multimodal Epicardial and Endocardial COronary PHYsiological Evaluation in Pathological Situations

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06008041
Acronym
PHYCO
Enrollment
400
Registered
2023-08-23
Start date
2023-07-13
Completion date
2027-04-01
Last updated
2023-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Coronary Microvascular Dysfunction

Keywords

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

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.

Interventions

None listed

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Index of Microcirculatory Resistance (IMR)During coronary angiographyIMR = Pd x Tmn at maximal hyperhemia Normal range \< 25

Secondary

MeasureTime frameDescription
Coronary Flow Reserve (CFR)During coronary angiographyCFR = Hyperhemic flow / Resting flow Normal value \> 2
Resting Full cycle Ratio (RFR)During coronary angiographyLowest Pd/Pa value in systole and diastole (mean of 5 consecutive cardiac cycles) Normal value \> 0.80
Quantitative Flow Ratio (QFR)During coronary angiographyNormal value \> 0.80
Fractional Flow Reserve (FFR)During coronary angiographyFFR = Pd/Pa at maximal hyperhemia Normal value \> 0.80
Death12 months
Angina pectoris (CCS)12 monthsGrade 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
Angio-IMRDuring coronary angiographyEstimated hyperemic Pa × angio-FFR × \[vessel length/(K × Vdiastole)\] Normal value \< 25

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026