Perioperative Management of Patients With Coronary Stents Undergoing Noncardiac Surgery

NCT ID: NCT01171612

Last Updated: 2016-04-07

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

483 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2012-07-31

Brief Summary

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The purpose of this study is to evaluate and monitor perioperative management of patients with coronary stents undergoing noncardiac surgery.

Objectives:

* To describe the incidence and severity of adverse cardiovascular events in patients with coronary stents undergoing noncardiac surgery with admission.
* To assess the following-up of the guidelines about the perioperative management of antiplatelet therapy in these patients.
* To assess the relationship between the incidence of cardiac or neurovascular events, as well as bleeding complications with the perioperative management of antiplatelet therapy.
* Number of Participants with Adverse Events as a Measure of Safety

Detailed Description

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(Not desired)

Conditions

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Acute Coronary Syndrome Coronary Stent Occlusion Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Coronary Stent

Patients with coronary Bare Metal Stent (BMS) or Drug Eluting Stent (DES) undergoing noncardiac surgery

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* \> 18 years old, with coronary stents
* American Society of Anaesthesia physical status II-V
* noncardiac surgery wiht admission
* informed consent

Exclusion Criteria

* \< 18 years old
* American Society of Anaesthesia physical status I
* ambulatory surgery
* pregnancy
* obstetric anaesthesia
* endoscopic procedures
* cardiac surgery
* not informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Corporacion Parc Tauli

OTHER

Sponsor Role lead

Responsible Party

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Anna Rodriguez Pont

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anna Rodriguez-Pont, MD

Role: PRINCIPAL_INVESTIGATOR

Corporacio Sanitaria Parc Tauli

Locations

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Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Site Status

Hospital Municipal de Badalona

Badalona, Barcelona, Spain

Site Status

Fundació Puigvert - IUNA

Barcelona, Barcelona, Spain

Site Status

Hospital Clínic

Barcelona, Barcelona, Spain

Site Status

Parc de Salut Mar-Esperança

Barcelona, Barcelona, Spain

Site Status

Parc de Salut Mar

Barcelona, Barcelona, Spain

Site Status

Hospital Igualada

Igualada, Barcelona, Spain

Site Status

Hospital de Mataró

Mataró, Barcelona, Spain

Site Status

Hospital de Sabadell. Corporació Sanitària Parc Taulí

Sabadell, Barcelona, Spain

Site Status

Hospital de Sant Celoni

Sant Celoni, Barcelona, Spain

Site Status

Clínica ASEPEYO

Sant Cugat del Vallès, Barcelona, Spain

Site Status

Hospital Sant Joan Despi Moisès Broggi

Sant Joan Despí, Barcelona, Spain

Site Status

Hospital Mútua de Terrassa

Terrassa, Barcelona, Spain

Site Status

Countries

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Spain

References

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Rodriguez A, Guilera N, Mases A, Sierra P, Oliva JC, Colilles C; REGISTRESTENTS group. Management of antiplatelet therapy in patients with coronary stents undergoing noncardiac surgery: association with adverse events. Br J Anaesth. 2018 Jan;120(1):67-76. doi: 10.1016/j.bja.2017.11.012. Epub 2017 Nov 21.

Reference Type DERIVED
PMID: 29397139 (View on PubMed)

Other Identifiers

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CIR2009017

Identifier Type: -

Identifier Source: org_study_id

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