Clinical trial NCT01045850: Prospective Cohort of Patient With Coronary Stents Undergoing Non Cardiac Surgery
Official title: Multicenter, Prospective Cohort of Patient With Coronary Stents Undergoing Non Cardiac Surgery or Invasive Procedures.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Complications
Hemorrhagic Complications
Keywords: coronary stents
non cardiac surgery
cardiovascular complications
hemorrhagic complications
antiplatelet agents
bare metal stent
drug eluting stent
surgery
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2010-01-11
Enrollment: 1312
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with coronary stents undergoing non cardiac surgery or invasive procedures

Brief 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.


Eligibility 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

Primary outcomes:
measure: Composite cardiovascular and hemorrhagic postoperative complications
timeFrame: 30 days
Secondary outcomes:
measure: Postoperative death
timeFrame: 30 days
Other outcomes:
Locations:
city: Aix En Provence
country: France
facility: HOSPITAL
city: Albi
country: France
facility: HOSPITAL
city: Amiens
country: France
facility: HOSPITAL
city: Angers
country: France
facility: HOSPITAL
city: Avignon
country: France
facility: HOSPITAL
city: Beaumont
country: France
facility: HOSPITAL
city: Berck Sur Mer
country: France
facility: HOSPITAL
city: Besancon
country: France
facility: HOSPITAL
city: Bordeaux
country: France
facility: HOSPITAL
city: Cabestany
country: France
facility: HOSPITAL
city: Castres
country: France
facility: HOSPITAL
city: Cavaillon
country: France
facility: HOSPITAL
city: Chalon En Champagne
country: France
facility: HOSPITAL
city: Chenove
country: France
facility: HOSPITAL
city: Clermont Ferrand
country: France
facility: HOSPITAL
city: Cornebarrieu
country: France
facility: HOSPITAL
city: Dracy Le Fort
country: France
facility: HOSPITAL
city: Equeurdreville
country: France
facility: HOSPITAL
city: Grenoble
country: France
facility: HOSPITAL
city: Hyeres
country: France
facility: HOSPITAL
city: Istres Cedex
country: France
facility: HOSPITAL
city: La Roche Sur Yon
country: France
facility: HOSPITAL
city: La Rochelle
country: France
facility: HOSPITAL
city: La Seyne Sur Mer
country: France
facility: HOSPITAL
city: Le Mans
country: France
facility: HOSPITAL
city: Lyon
country: France
facility: HOSPITAL
city: Manosque
country: France
facility: HOSPITAL
city: Mantes La Jolie
country: France
facility: HOSPITAL
city: Marseille
country: France
facility: HOSPITAL
city: Maubeuge
country: France
facility: HOSPITAL
city: Metz
country: France
facility: HOSPITAL
city: Montpellier
country: France
facility: HOSPITAL
city: Mulhouse
country: France
facility: HOSPITAL
city: Nancy
country: France
facility: HOSPITAL
city: Nantes
country: France
facility: HOSPITAL
city: Nice
country: France
facility: HOSPITAL
city: Niort
country: France
facility: HOSPITAL
city: Paris
country: France
facility: HOSPITAL
city: Perpignan
country: France
facility: HOSPITAL
city: Pierre Benite
country: France
facility: HOSPITAL
city: Redon
country: France
facility: HOSPITAL
city: Rennes
country: France
facility: HOSPITAL
city: Romans
country: France
facility: HOSPITAL
city: Rouen
country: France
facility: HOSPITAL
city: Saint Denis
country: France
facility: HOSPITAL
city: Saint Dizier
country: France
facility: HOSPITAL
city: Saint Etienne
country: France
facility: HOSPITAL
city: Saint Herblain Cedex
country: France
facility: HOSPITAL
city: Saint Malo
country: France
facility: HOSPITAL
city: Toulouse
country: France
facility: HOSPITAL
city: Trelaze
country: France
facility: HOSPITAL
city: Villeneuve Sur Lot
country: France
facility: HOSPITAL
city: Voiron
country: France
facility: HOSPITAL
Study officials:
affiliation: University Hospital, Grenoble
name: Pierre ALBALADEJO, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Albaladejo P, Charbonneau H, Samama CM, Collet JP, Marret E, Piriou V, Genty C, Bosson JL. Bleeding complications in patients with coronary stents during non-cardiac surgery. Thromb Res. 2014 Aug;134(2):268-72. doi: 10.1016/j.thromres.2014.05.015. Epub 2014 May 15.
citation: Albaladejo P, Marret E, Samama CM, Collet JP, Abhay K, Loutrel O, Charbonneau H, Jaber S, Thoret S, Bosson JL, Piriou V. Non-cardiac surgery in patients with coronary stents: the RECO study. Heart. 2011 Oct;97(19):1566-72. doi: 10.1136/hrt.2011.224519. Epub 2011 Jul 26.