Perioperative Management of Patients With Coronary Stents Undergoing Noncardiac Surgery

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

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Coronary Stent Occlusion Heart Diseases Hemorrhage Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Surgery Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain

About this study

(Not desired)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Major Adverse Cardiac and Cerebrovascular Events (MACCEs)

Time frame: up to 90 days after surgery

Cardiac Mortality, Myocardial Infarction, Angina Pectoris, new arrythmia, Congestive Heart Failure, Stroke, Cardiac Arrest

Secondary outcomes

Major Haemorrhagic Events

Time frame: 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

Time frame: 90 days after surgery
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

Sponsors and collaborators

Lead sponsor

Corporacion Parc Tauli

Other

Registry information

Official study title

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

Acronym: RegistStents

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2012
First posted: Jul 28, 2010
Registry last updated: Apr 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed