Prospective Cohort of Patient With Coronary Stents Undergoing Non Cardiac Surgery

Cardiovascular Complications Clinical Trial

— RECO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01045850
• Other study ID #: DTCIC-09-29
• Secondary ID: CFAR
• Status: Completed
• Phase: N/A
• First received: January 7, 2010
• Last updated: January 12, 2010
• Start date: February 2006
• Est. completion date: January 2010

Study information

• Verified date: January 2010
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1312
• Est. completion date: January 2010
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Complications
• Hemorrhagic Complications

Locations

Country	Name	City	State
France	HOSPITAL	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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite cardiovascular and hemorrhagic postoperative complications		30 days	No
Secondary	Postoperative death		30 days	No