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France PCI Registry : National Observatory of Interventional Cardiology

Sponsor
Club Régional des Angioplasticiens de la région Centre (Other)
Overall Status
Recruiting
CT.gov ID
NCT02778724
Collaborator
Agence Régional de Santé du Centre (Other), Direction Générale de l'Offre de Soins (Other), France PCI Association (Other)
40,000
Enrollment
15
Locations
203
Duration (Months)
2666.7
Patients Per Site
13.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Rigorous clinical practice assessment is a key factor to improve patient's care and prognosis in interventional cardiology (IC). A multicentric IC observational study (CRAC), fully integrated to usual coronary activity report software, started in Centre Val de Loire (CVL) region in 2014.

CRAC observatory was conduced on five IC CathLab of CVL region. Quality of collected data is regularly evaluated and allowed building an exhaustive, and reliable database. This solution could easily be developed in other French regions.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    40000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    France PCI Registry : National Observatory of Interventional Cardiology
    Study Start Date :
    Jan 1, 2014
    Anticipated Primary Completion Date :
    Jan 1, 2030
    Anticipated Study Completion Date :
    Dec 1, 2030

    Outcome Measures

    Primary Outcome Measures

    1. Census of interventional cardiology activity [1 year]

      Census, follow-up and monitoring of patients during 1 year, after a coronary angioplasty

    Secondary Outcome Measures

    1. Optimization of STEMI patient care time [Less than 24 hours]

      Manage STEMI < H24 patients, record and monitor time intervals from first pain to first medical contact in order to achieve and maintain the quality of care

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age =>18 years at enrollment

    • Patient who have had a coronary angiogram or angioplasty

    Exclusion Criteria:
    • Patient who didn't want to participated

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Cardiology Unit / Les hopitaux de Chartres Le Coudray Eure Et Loire France 28630
    2 Centre Hospitalier Henri Mondor d'Aurillac Aurillac France 15002
    3 Centre Hospitalier Jacques Coeur de Bourges Bourges France 18020
    4 CHU Caen - Hôpital Côte de Nacre Caen France 14033
    5 Hôpital Privé Saint-Martin Caen Caen France 14050
    6 CHRU Hôpitaux de Tours - Trousseau Chambray-lès-Tours France 37170
    7 CHU Gabriel-Montpied de Clermont-Ferrand Clermont-Ferrand France 63003
    8 Hôpital Privé de l'Estuaire Le Havre France 76620
    9 Groupe Hospitalier du Havre - Hôpital Jacques Monod Montivilliers France 76290
    10 CHR Orléans - Hôpital de la Source Orléans France 45100
    11 CHU de Rouen - Hôpital Charles-Nicolle Rouen France 76031
    12 Clinique Saint-Hilaire - Rouen Rouen France 76044
    13 Pôle Santé Oréliance - Clinique de la Reine Blanche Saran France 45770
    14 Clinique Saint-Gatien Tours France 37042
    15 Clinique Bergouignan Évreux France 27025

    Sponsors and Collaborators

    • Club Régional des Angioplasticiens de la région Centre
    • Agence Régional de Santé du Centre
    • Direction Générale de l'Offre de Soins
    • France PCI Association

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Club Régional des Angioplasticiens de la région Centre
    ClinicalTrials.gov Identifier:
    NCT02778724
    Other Study ID Numbers:
    • France PCI
    First Posted:
    May 20, 2016
    Last Update Posted:
    Apr 7, 2022
    Last Verified:
    Mar 1, 2022

    Study Results

    No Results Posted as of Apr 7, 2022