NCT02778724

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40,000

participants targeted

Target at P75+ for all trials

Timeline
56mo left

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

15 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Jan 2014Dec 2030

Study Start

First participant enrolled

January 1, 2014

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 18, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 20, 2016

Completed
13.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

April 7, 2022

Status Verified

March 1, 2022

Enrollment Period

16 years

First QC Date

May 18, 2016

Last Update Submit

March 29, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Census of interventional cardiology activity

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

    1 year

Secondary Outcomes (1)

  • Optimization of STEMI patient care time

    Less than 24 hours

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients aged over 18 undergoing coronary angiogram or angioplasty

You may qualify if:

  • Age =\>18 years at enrollment
  • Patient who have had a coronary angiogram or angioplasty

You may not qualify if:

  • Patient who didn't want to participated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Research Cardiology Unit / Les hopitaux de Chartres

Le Coudray, Eure Et Loire, 28630, France

RECRUITING

Centre Hospitalier Henri Mondor d'Aurillac

Aurillac, 15002, France

RECRUITING

Centre Hospitalier Jacques Coeur de Bourges

Bourges, 18020, France

RECRUITING

CHU Caen - Hôpital Côte de Nacre

Caen, 14033, France

RECRUITING

Hôpital Privé Saint-Martin Caen

Caen, 14050, France

NOT YET RECRUITING

CHRU Hôpitaux de Tours - Trousseau

Chambray-lès-Tours, 37170, France

RECRUITING

CHU Gabriel-Montpied de Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

Clinique Bergouignan

Évreux, 27025, France

NOT YET RECRUITING

Hôpital Privé de l'Estuaire

Le Havre, 76620, France

RECRUITING

Groupe Hospitalier du Havre - Hôpital Jacques Monod

Montivilliers, 76290, France

RECRUITING

CHR Orléans - Hôpital de la Source

Orléans, 45100, France

RECRUITING

CHU de Rouen - Hôpital Charles-Nicolle

Rouen, 76031, France

RECRUITING

Clinique Saint-Hilaire - Rouen

Rouen, 76044, France

RECRUITING

Pôle Santé Oréliance - Clinique de la Reine Blanche

Saran, 45770, France

RECRUITING

Clinique Saint-Gatien

Tours, 37042, France

RECRUITING

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Central Study Contacts

Gregoire Range, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2016

First Posted

May 20, 2016

Study Start

January 1, 2014

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

April 7, 2022

Record last verified: 2022-03

Locations