NCT01045850

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,312

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2006

Longer than P75 for all trials

Geographic Reach
1 country

53 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 11, 2010

Completed
Last Updated

January 13, 2010

Status Verified

January 1, 2010

Enrollment Period

3.3 years

First QC Date

January 7, 2010

Last Update Submit

January 12, 2010

Conditions

Keywords

coronary stentsnon cardiac surgerycardiovascular complicationshemorrhagic complicationsantiplatelet agentsbare metal stentdrug eluting stentsurgery

Outcome Measures

Primary Outcomes (1)

  • Composite cardiovascular and hemorrhagic postoperative complications

    30 days

Secondary Outcomes (1)

  • Postoperative death

    30 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with coronary stents undergoing non cardiac surgery or invasive procedures

You may qualify if:

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

You may not qualify if:

  • patient less than 18 years
  • patient unable to understand

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (53)

HOSPITAL

Aix-en-Provence, France

Location

HOSPITAL

Albi, France

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HOSPITAL

Amiens, France

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HOSPITAL

Angers, France

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Avignon, France

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Beaumont, France

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Berck, France

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Besançon, 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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Chenôve, France

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Clermont-Ferrand, France

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HOSPITAL

Cornebarrieu, France

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HOSPITAL

Dracy-le-Fort, France

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HOSPITAL

Équeurdreville-Hainneville, France

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HOSPITAL

Grenoble, France

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HOSPITAL

Hyères, France

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Istres, France

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HOSPITAL

La Roche-sur-Yon, France

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HOSPITAL

La Rochelle, France

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HOSPITAL

La Seyne-sur-Mer, France

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HOSPITAL

Le Mans, France

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HOSPITAL

Lyon, France

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HOSPITAL

Manosque, France

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Mantes-la-Jolie, France

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Marseille, France

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Maubeuge, France

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Metz, France

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Montpellier, France

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Mulhouse, France

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HOSPITAL

Nancy, France

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Nantes, France

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HOSPITAL

Nice, France

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HOSPITAL

Niort, France

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HOSPITAL

Paris, France

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HOSPITAL

Perpignan, France

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HOSPITAL

Pierre-Bénite, France

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HOSPITAL

Redon, France

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HOSPITAL

Rennes, France

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Romans, France

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Rouen, France

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Saint-Denis, France

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HOSPITAL

Saint-Dizier, France

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HOSPITAL

Saint-Etienne, France

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HOSPITAL

Saint-Herblain, France

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HOSPITAL

St-Malo, France

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HOSPITAL

Toulouse, France

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HOSPITAL

Trélazé, France

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HOSPITAL

Villeneuve-sur-Lot, France

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HOSPITAL

Voiron, France

Location

Related Publications (2)

  • 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.

  • 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.

Study Officials

  • Pierre ALBALADEJO, MD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 7, 2010

First Posted

January 11, 2010

Study Start

February 1, 2006

Primary Completion

June 1, 2009

Study Completion

January 1, 2010

Last Updated

January 13, 2010

Record last verified: 2010-01

Locations