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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01045850
First received: January 7, 2010
Last updated: January 12, 2010
Last verified: January 2010
History of Changes
  Purpose

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.


Condition
Cardiovascular Complications
Hemorrhagic Complications

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicenter, Prospective Cohort of Patient With Coronary Stents Undergoing Non Cardiac Surgery or Invasive Procedures.

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners
U.S. FDA Resources

Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • Composite cardiovascular and hemorrhagic postoperative complications [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Postoperative death [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment: 1312
Study Start Date: February 2006
Study Completion Date: January 2010
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with coronary stents undergoing non cardiac surgery or invasive procedures

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01045850

  Show 53 Study Locations
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Pierre ALBALADEJO, MD University Hospital, Grenoble
  More Information

No publications provided by University Hospital, Grenoble

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Professor ALBALADEJO Pierre, University Hospital Grenoble
ClinicalTrials.gov Identifier: NCT01045850     History of Changes
Other Study ID Numbers: DTCIC-09-29, CFAR
Study First Received: January 7, 2010
Last Updated: January 12, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Grenoble:
coronary stents
non cardiac surgery
cardiovascular complications
hemorrhagic complications
 antiplatelet agents
bare metal stent
drug eluting stent
surgery

Additional relevant MeSH terms:
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013