NCT01171612

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
483

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2009

Typical duration for all trials

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 28, 2010

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

November 25, 2013

Completed
Last Updated

April 7, 2016

Status Verified

March 1, 2016

Enrollment Period

8 months

First QC Date

July 23, 2010

Results QC Date

August 13, 2013

Last Update Submit

March 8, 2016

Conditions

Acute Coronary SyndromeCoronary Stent OcclusionSurgery

Keywords

Coronary StentBMS stentDES stentDate of stent implantationcardiac eventneurovascular eventBleedingtransfusion

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Major Haemorrhagic Events

    up to 90 days after surgery

  • Number of Patients With Adverse Events Related With Antiplatelet Therapy Management

    90 days after surgery

Study Arms (1)

Coronary Stent

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with coronary stents undergoing noncardiac surgery with admission between May 2010 and April 2012

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Location

Hospital Municipal de Badalona

Badalona, Barcelona, Spain

Location

Fundació Puigvert - IUNA

Barcelona, Barcelona, Spain

Location

Hospital Clínic

Barcelona, Barcelona, Spain

Location

Parc de Salut Mar-Esperança

Barcelona, Barcelona, Spain

Location

Parc de Salut Mar

Barcelona, Barcelona, Spain

Location

Hospital Igualada

Igualada, Barcelona, Spain

Location

Hospital de Mataró

Mataró, Barcelona, Spain

Location

Hospital de Sabadell. Corporació Sanitària Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Hospital de Sant Celoni

Sant Celoni, Barcelona, Spain

Location

Clínica ASEPEYO

Sant Cugat del Vallès, Barcelona, Spain

Location

Hospital Sant Joan Despi Moisès Broggi

Sant Joan Despí, Barcelona, Spain

Location

Hospital Mútua de Terrassa

Terrassa, Barcelona, 08221, Spain

Location

Related Publications (1)

  • 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.

    PMID: 29397139DERIVED

MeSH Terms

Conditions

Acute Coronary SyndromeCardiovascular DiseasesHemorrhage

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesVascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

This is a prospective and observational study

Results Point of Contact

Title
Anna Rodriguez-Pont
Organization
Corporacion Sanitaria y Universitaria Parc Tauli
anna.r.pont@gmail.com
0034937231010

Study Officials

  • Anna Rodriguez-Pont, MD

    Corporacio Sanitaria Parc Tauli

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 23, 2010

First Posted

July 28, 2010

Study Start

June 1, 2009

Primary Completion

February 1, 2010

Study Completion

July 1, 2012

Last Updated

April 7, 2016

Results First Posted

November 25, 2013

Record last verified: 2016-03

Locations

ES(13)