Perioperative Management of Patients With Coronary Stents Undergoing Noncardiac Surgery

Completed

• Conditions: Acute Coronary Syndrome; Surgery; Coronary Stent Occlusion

• Registration Number: NCT01171612
• Lead Sponsor: Corporacion Parc Tauli

Brief Summary

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

(Not desired)

Study Timeline

• Study Start: 2009-06
• Primary Completion: 2010-02
• Study First Submitted: 2010-07-23
• Study First Submitted QC: 2010-07-27
• Study First Posted: 2010-07-28
• Study Completion: 2012-07
• Results First Submitted: 2013-08-13
• Results First Submitted QC: 2013-09-16
• Results First Posted: 2013-11-25
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-08
• Last Update Posted: 2016-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 483

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major Adverse Cardiac and Cerebrovascular Events (MACCEs)	up to 90 days after surgery	Cardiac Mortality, Myocardial Infarction, Angina Pectoris, new arrythmia, Congestive Heart Failure, Stroke, Cardiac Arrest

Secondary Outcome Measures

Name	Time	Method
Major Haemorrhagic Events	up to 90 days after surgery	Transfusion \> = 2 red blood cells Units, haemoglobin descent \>= 20 gr/dL, intracerebral haemorrhage
Number of Patients With Adverse Events Related With Antiplatelet Therapy Management	90 days after surgery	Perioperative withdrawal antiplatelet therapy is defined with \> or = 5 days without therapy; We create 3 categories: 1. Not withdrawal; 2. Complete withdrawal (5 or \> days without antiplatelet drugs , mono or dual therapy); 3. Incomplete withdrawal: patients under dual antiplatelet therapy, who maintain aspirin and stopped clopidogrel =/ \> 5 days

Trial Locations

Locations (13)

Hospital Municipal de Badalona; 🇪🇸 Badalona, Barcelona, Spain

Hospital Igualada; 🇪🇸 Igualada, Barcelona, Spain

Hospital de Sabadell. Corporació Sanitària Parc Taulí; 🇪🇸 Sabadell, Barcelona, Spain

Hospital de Sant Celoni; 🇪🇸 Sant Celoni, Barcelona, Spain

Clínica ASEPEYO; 🇪🇸 Sant Cugat del Valles, Barcelona, Spain

Hospital Sant Joan Despi Moisès Broggi; 🇪🇸 Sant Joan Despi, Barcelona, Spain

Hospital Mútua de Terrassa; 🇪🇸 Terrassa, Barcelona, Spain

Hospital Clínic; 🇪🇸 Barcelona, Spain

Parc de Salut Mar; 🇪🇸 Barcelona, Spain

Fundació Puigvert - IUNA; 🇪🇸 Barcelona, Spain

Parc de Salut Mar-Esperança; 🇪🇸 Barcelona, Spain

Hospital de Mataró; 🇪🇸 Mataró, Barcelona, Spain

Hospital Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain