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Pronostic Impact of Flow Fraction Reserve on Intermediate Stenoses

Sponsor
Groupe Hospitalier Paris Saint Joseph (Other)
Overall Status
Completed
CT.gov ID
NCT03588455
Collaborator
(none)
91
Enrollment
1
Location
5.9
Actual Duration (Months)
15.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The intermediate coronary stenoses defined by a degree of stenosis from 40 to 70 % are frequent. The Flow Fraction Reserve (FFR), realized during coronarography, is an hemodynamic evaluation by the functional impact measuring the loss of load in upstream / approval of the stenosis inthe basal state and in situation of hyperemia led by adenosine. Further to the study FAME, the threshold of definition of the significant character of one Stenosis was fixed for a value of FFR = 0,80. However, the impact forecasts intermediate values badly known rest.

We hypothetized that coronary stenosis associated with borderline values of FFR 0.81-0.85 were associated with a higher rate of clinical events than those with a FFR >0.85

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    91 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Pronostic Impact of Flow Fraction Reserve on Intermediate Stenoses
    Actual Study Start Date :
    Jan 1, 2018
    Actual Primary Completion Date :
    Apr 30, 2018
    Actual Study Completion Date :
    Jun 30, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Composite outcome [3 years]

      cardiovascular mortality or acute coronary syndrom or revascularization or cardiovascular rehospitalisation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • patient with FFR> 0,80 between september 2012 till december 2016
    Exclusion Criteria:
    • refusal of participation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Groupe Hospitalier Paris Saint Joseph Paris Ile-de-France France 75014

    Sponsors and Collaborators

    • Groupe Hospitalier Paris Saint Joseph

    Investigators

    • Principal Investigator: AZZAZ P Sofien, MD, Groupe Hospitalier Paris Saint Joseph

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Groupe Hospitalier Paris Saint Joseph
    ClinicalTrials.gov Identifier:
    NCT03588455
    Other Study ID Numbers:
    • FFR
    First Posted:
    Jul 17, 2018
    Last Update Posted:
    Aug 8, 2018
    Last Verified:
    Aug 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Coronary Stenosis
    Constriction, Pathologic

    Study Results

    No Results Posted as of Aug 8, 2018