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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
France
HOSPITAL
Aix En Provence, France
HOSPITAL
Albi, France
HOSPITAL
Amiens, France
HOSPITAL
Angers, France
HOSPITAL
Avignon, France
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Beaumont, France
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Berck Sur Mer, France
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Besancon, France
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Bordeaux, France
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Cabestany, France
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Castres, France
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Cavaillon, France
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Chalon En Champagne, France
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Chenove, France
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Clermont Ferrand, France
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Cornebarrieu, France
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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
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Niort, France
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Paris, France
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Perpignan, France
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Pierre Benite, France
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Redon, France
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Rennes, France
HOSPITAL
Romans, France
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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
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 August 28, 2014