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Active, not recruiting Observational

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

NCT06008041 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2023-07-13
Last updated
2023-08-28

Condition(s) studied

Coronary Artery DiseaseCoronary Microvascular Dysfunction

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
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

Primary outcome measure(s)

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

Trial sites (1)

FacilityCityRegionStatus
Chu Brest Brest France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06008041 on ClinicalTrials.gov ↗ ← All trials in France