Prospective Cohort of Patient With Coronary Stents Undergoing Non Cardiac Surgery (RECO)

January 12, 2010 updated by: University Hospital, Grenoble

Multicenter, Prospective Cohort of Patient With Coronary Stents Undergoing Non Cardiac Surgery or Invasive Procedures.

Non cardiac surgery in patients with coronary stents is complicated with cardiovascular and hemorrhagic events associated with perioperative management of antiplatelet agents. Several guidelines have outlined the importance of maintaining antiplatelet agents throughout surgical procedures to prevent cardiovascular complications. On the other hand, interruption of antiplatelet agents is still a usual standard to avoid surgical complications. We investigate the impact of perioperative antiplatelet drugs management on these complications, through a multicenter, prospective cohort (RECO stands for "Registre des patients porteurs d'Endoprothèses Coronaires, Opérés de chirurgie non cardiaque"), including all patients with coronary stents undergoing non cardiac surgery or invasive procedures. The aim of this study is primarily to measure the incidence of cardiovascular (including stent thrombosis) and hemorrhagic complications and to identify pre and postoperative risk factors associated with these complications.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1312

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Aix En Provence, France
        • Hospital
      • Albi, France
        • Hospital
      • Amiens, France
        • Hospital
      • Angers, France
        • Hospital
      • Avignon, France
        • Hospital
      • Beaumont, France
        • Hospital
      • Berck Sur Mer, France
        • Hospital
      • Besancon, France
        • Hospital
      • Bordeaux, France
        • Hospital
      • Cabestany, France
        • Hospital
      • Castres, France
        • Hospital
      • Cavaillon, France
        • Hospital
      • Chalon En Champagne, France
        • Hospital
      • Chenove, France
        • Hospital
      • Clermont Ferrand, France
        • Hospital
      • Cornebarrieu, France
        • Hospital
      • Dracy Le Fort, France
        • Hospital
      • Equeurdreville, France
        • Hospital
      • Grenoble, France
        • Hospital
      • Hyeres, France
        • Hospital
      • Istres Cedex, France
        • Hospital
      • La Roche Sur Yon, France
        • Hospital
      • La Rochelle, France
        • Hospital
      • La Seyne Sur Mer, France
        • Hospital
      • Le Mans, France
        • Hospital
      • Lyon, France
        • Hospital
      • Manosque, France
        • Hospital
      • Mantes La Jolie, France
        • Hospital
      • Marseille, France
        • Hospital
      • Maubeuge, France
        • Hospital
      • Metz, France
        • Hospital
      • Montpellier, France
        • Hospital
      • Mulhouse, France
        • Hospital
      • Nancy, France
        • Hospital
      • Nantes, France
        • Hospital
      • Nice, France
        • Hospital
      • Niort, France
        • Hospital
      • Paris, France
        • Hospital
      • Perpignan, France
        • Hospital
      • Pierre Benite, France
        • Hospital
      • Redon, France
        • Hospital
      • Rennes, France
        • Hospital
      • Romans, France
        • Hospital
      • Rouen, France
        • Hospital
      • Saint Denis, France
        • Hospital
      • Saint Dizier, France
        • Hospital
      • Saint Etienne, France
        • Hospital
      • Saint Herblain Cedex, France
        • Hospital
      • Saint Malo, France
        • Hospital
      • Toulouse, France
        • Hospital
      • Trelaze, France
        • Hospital
      • Villeneuve Sur Lot, France
        • Hospital
      • Voiron, France
        • Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with coronary stents undergoing non cardiac surgery or invasive procedures

Description

Inclusion Criteria:

  • 18 years old or more
  • patient requiring a non cardiac surgery
  • patient with a coronary stent
  • patient agree for personal health data collection and analysis

Exclusion Criteria:

  • patient less than 18 years
  • patient unable to understand

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Composite cardiovascular and hemorrhagic postoperative complications
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Postoperative death
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Pierre ALBALADEJO, MD, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

January 7, 2010

First Submitted That Met QC Criteria

January 8, 2010

First Posted (Estimate)

January 11, 2010

Study Record Updates

Last Update Posted (Estimate)

January 13, 2010

Last Update Submitted That Met QC Criteria

January 12, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DTCIC-09-29
  • CFAR (Other Identifier: Collège Français d'Anesthésie Réanimation)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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