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

Sponsor
University Hospital, Brest (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT06008041
Collaborator
(none)
400
Enrollment
1
Location
44.6
Anticipated Duration (Months)
9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    400 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Multimodal Epicardial and Endocardial COronary PHYsiological Evaluation in Pathological Situations
    Actual Study Start Date :
    Jul 13, 2023
    Actual Primary Completion Date :
    Jul 13, 2023
    Anticipated Study Completion Date :
    Apr 1, 2027

    Outcome Measures

    Primary Outcome Measures

    1. Index of Microcirculatory Resistance (IMR) [During coronary angiography]

      IMR = Pd x Tmn at maximal hyperhemia Normal range < 25

    Secondary Outcome Measures

    1. Fractional Flow Reserve (FFR) [During coronary angiography]

      FFR = Pd/Pa at maximal hyperhemia Normal value > 0.80

    2. Coronary Flow Reserve (CFR) [During coronary angiography]

      CFR = Hyperhemic flow / Resting flow Normal value > 2

    3. 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

    4. Quantitative Flow Ratio (QFR) [During coronary angiography]

      Normal value > 0.80

    5. Angio-IMR [During coronary angiography]

      Estimated hyperemic Pa × angio-FFR × [vessel length/(K × Vdiastole)] Normal value < 25

    6. Death [12 months]

    7. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chu Brest Brest France 29609

    Sponsors and Collaborators

    • University Hospital, Brest

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Brest
    ClinicalTrials.gov Identifier:
    NCT06008041
    Other Study ID Numbers:
    • 29BRC23.0037 - PHYCO
    First Posted:
    Aug 23, 2023
    Last Update Posted:
    Aug 28, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Brest
    Coronary Artery Disease
    Coronary Physiology
    Index of Microcirculatory Resistance (IMR)
    Additional relevant MeSH terms:
    Coronary Artery Disease
    Myocardial Ischemia
    Coronary Disease

    Study Results

    No Results Posted as of Aug 28, 2023