Perioperative Management of Patients With Coronary Stents Undergoing Noncardiac Surgery

Surgery Clinical Trial

— RegistStents  

Official title:

Evaluation and Monitoring of Perioperative Management of Patients With Coronary Stents Undergoing Noncardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01171612
• Other study ID #: CIR2009017
• Status: Completed
• Phase: N/A
• First received: July 23, 2010
• Last updated: September 16, 2013
• Start date: June 2009
• Est. completion date: July 2012

Study information

• Verified date: September 2013
• Source: Corporacion Parc Tauli
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Observational

Clinical Trial 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

Description:

(Not desired)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 483
• Est. completion date: July 2012
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Stent Occlusion
• Surgery

Locations

Country	Name	City	State
Spain	Hospital Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital Municipal de Badalona	Badalona	Barcelona
Spain	Fundació Puigvert - IUNA	Barcelona
Spain	Hospital Clínic	Barcelona
Spain	Parc de Salut Mar	Barcelona
Spain	Parc de Salut Mar-Esperança	Barcelona
Spain	Hospital Igualada	Igualada	Barcelona
Spain	Hospital de Mataró	Mataró	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

Sponsors (1)

Lead Sponsor	Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Cardiac and Cerebrovascular Events (MACCEs)	Cardiac Mortality, Myocardial Infarction, Angina Pectoris, new arrythmia, Congestive Heart Failure, Stroke, Cardiac Arrest	up to 90 days after surgery	Yes
Secondary	Major Haemorrhagic Events	Transfusion > = 2 red blood cells Units, haemoglobin descent >= 20 gr/dL, intracerebral haemorrhage	up to 90 days after surgery	Yes
Secondary	Number of Patients With Adverse Events Related With Antiplatelet Therapy Management	Perioperative withdrawal antiplatelet therapy is defined with > or = 5 days without therapy; We create 3 categories: Not withdrawal; Complete withdrawal (5 or > days without antiplatelet drugs , mono or dual therapy); Incomplete withdrawal: patients under dual antiplatelet therapy, who maintain aspirin and stopped clopidogrel =/ > 5 days	90 days after surgery	Yes

External Links

•   study recruitment web page