AzTrials
AzTrials

InterventionalNCT02778724

France PCI Registry : National Observatory of Interventional Cardiology

An observational study of Interventional and Cardiology, run by Club Régional des Angioplasticiens de la région Centre at 15 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Interventional, Cardiology, Angioplasty
How many people
40,000 participants
Where
15 sitesFrance
Study dates
Jan 2014to Dec 2030
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: patients aged over 18 undergoing coronary angiogram or angioplasty

Who may be able to join

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

Who cannot join

  • Patient who didn't want to participated

Trial locations and contacts

15 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Gregoire Range, MD contact

registrecrac@ch-chartres.fr

15 sites in 1 country

France15 sites, 15 recruiting

  • Centre Hospitalier Henri Mondor d'Aurillac

    Aurillac, 15002

    Louis Viallard, MD

    Louis Viallard, MD

    Recruiting

  • Centre Hospitalier Jacques Coeur de Bourges

    Bourges, 18020

    Pierre Marcollet, MD

    Pierre Marcollet, MD

    Recruiting

  • CHU Caen - Hôpital Côte de Nacre

    Caen, 14033

    Farzin Beygui, MD

    Farzin Beygui, MD

    Recruiting

  • Hôpital Privé Saint-Martin Caen

    Caen, 14050

    Jean François Morelle, MD

    Jean François Morelle, MD

    Not yet recruiting

  • CHRU Hôpitaux de Tours - Trousseau

    Chambray-lès-Tours, 37170

    Denis Angoulvant, MD

    Denis Angoulvant, MD

    Recruiting

  • CHU Gabriel-Montpied de Clermont-Ferrand

    Clermont-Ferrand, 63003

    Pascal Motreff, MD

    Pascal Motreff, MD

    Recruiting

  • Clinique Bergouignan

    Évreux, 27025

    Gérard Dutheil, MD

    Gérard Dutheil, MD

    Not yet recruiting

  • Research Cardiology Unit / Les hopitaux de Chartres

    Le Coudray, Eure Et Loire, 28630

    Sandra Gautier

    Christophe Laure

    Recruiting

  • Hôpital Privé de l'Estuaire

    Le Havre, 76620

    Pierre François Lesault, MD

    Pierre François Lesault, MD

    Recruiting

  • Groupe Hospitalier du Havre - Hôpital Jacques Monod

    Montivilliers, 76290

    Philippe Bonnet, MD

    Philippe Bonnet, MD

    Recruiting

  • CHR Orléans - Hôpital de la Source

    Orléans, 45100

    Wael Yafi, MD

    Wael Yafi, MD

    Recruiting

  • CHU de Rouen - Hôpital Charles-Nicolle

    Rouen, 76031

    Eric Durand, MD

    Eric Durand, MD

    Recruiting

  • Clinique Saint-Hilaire - Rouen

    Rouen, 76044

    René Koning, MD

    René Koning, MD

    Recruiting

  • Pôle Santé Oréliance - Clinique de la Reine Blanche

    Saran, 45770

    Philippe Dequenne, MD

    Philippe Dequenne, MD

    Recruiting

  • Clinique Saint-Gatien

    Tours, 37042

    Stephan Chassaing, MD

    Stephan Chassaing, MD

    Recruiting

Other trials in France

About this study

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.

Medical subject headings
ST Elevation Myocardial Infarction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Census of interventional cardiology activity

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

    Measured: 1 year

Secondary outcomes (1)

  1. Optimization of STEMI patient care time

    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

    Measured: Less than 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2016 (estimated)
  2. Study startJan 2014
  3. Primary completionJan 2030 (estimated)
  4. Study completionDec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
40,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02778724
Sponsor's protocol ID
France PCI
Status last verified
Mar 2022
First submitted
18 May 2016
Last updated
7 Apr 2022
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Interventional and Cardiology, run by Club Régional des Angioplasticiens de la région Centre at 15 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gregoire Range, MD (registrecrac@ch-chartres.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Census of interventional cardiology activity (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02778724.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.

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