Clinical trial NCT01171612: Perioperative Management of Patients With Coronary Stents Undergoing Noncardiac Surgery
Official title: Evaluation and Monitoring of Perioperative Management of Patients With Coronary Stents Undergoing Noncardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Coronary Stent Occlusion
Surgery
Keywords: Coronary Stent
BMS stent
DES stent
Date of stent implantation
cardiac event
neurovascular event
Bleeding
transfusion
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2010-07-28
Enrollment: 483
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with coronary stents undergoing noncardiac surgery with admission between May 2010 and April 2012

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)

Eligibility criteria: 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

Primary outcomes:
measure: Major Adverse Cardiac and Cerebrovascular Events (MACCEs)
timeFrame: up to 90 days after surgery
Secondary outcomes:
measure: Major Haemorrhagic Events
timeFrame: up to 90 days after surgery
measure: Number of Patients With Adverse Events Related With Antiplatelet Therapy Management
timeFrame: 90 days after surgery
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona
city: Badalona
country: Spain
facility: Hospital Municipal de Badalona
state: Barcelona
city: Igualada
country: Spain
facility: Hospital Igualada
state: Barcelona
city: Mataró
country: Spain
facility: Hospital de Mataró
state: Barcelona
city: Sabadell
country: Spain
facility: Hospital de Sabadell. Corporació Sanitària Parc Taulí
state: Barcelona
city: Sant Celoni
country: Spain
facility: Hospital de Sant Celoni
state: Barcelona
city: Sant Cugat del Valles
country: Spain
facility: Clínica ASEPEYO
state: Barcelona
city: Sant Joan Despi
country: Spain
facility: Hospital Sant Joan Despi Moisès Broggi
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital Mútua de Terrassa
state: Barcelona
city: Barcelona
country: Spain
facility: Fundació Puigvert - IUNA
city: Barcelona
country: Spain
facility: Hospital Clínic
city: Barcelona
country: Spain
facility: Parc de Salut Mar-Esperança
city: Barcelona
country: Spain
facility: Parc de Salut Mar
Study officials:
affiliation: Corporacio Sanitaria Parc Tauli
name: Anna Rodriguez-Pont, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.