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Perioperative Management of Patients With Coronary Stents Undergoing Noncardiac Surgery (RegistStents)

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ClinicalTrials.gov Identifier: NCT01171612
Recruitment Status : Completed
First Posted : July 28, 2010
Results First Posted : November 25, 2013
Last Update Posted : April 7, 2016
Sponsor:
Information provided by (Responsible Party):
Anna Rodriguez Pont, 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

Condition or disease
Acute Coronary Syndrome Coronary Stent Occlusion Surgery

Detailed Description:
(Not desired)

Study Type : Observational
Actual Enrollment : 483 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation and Monitoring of Perioperative Management of Patients With Coronary Stents Undergoing Noncardiac Surgery
Study Start Date : June 2009
Actual Primary Completion Date : February 2010
Actual Study Completion Date : July 2012

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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Major Haemorrhagic Events [ Time Frame: up to 90 days after surgery ]
    Transfusion > = 2 red blood cells Units, haemoglobin descent >= 20 gr/dL, intracerebral haemorrhage

  2. 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:

    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with coronary stents undergoing noncardiac surgery with admission between May 2010 and April 2012
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01171612


Locations
Spain
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Municipal de Badalona
Badalona, Barcelona, Spain
Hospital Igualada
Igualada, Barcelona, Spain
Hospital de Mataró
Mataró, Barcelona, Spain
Hospital de Sabadell. Corporació Sanitària Parc Taulí
Sabadell, Barcelona, Spain, 08208
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, 08221
Fundació Puigvert - IUNA
Barcelona, Spain
Hospital Clínic
Barcelona, Spain
Parc de Salut Mar-Esperança
Barcelona, Spain
Parc de Salut Mar
Barcelona, Spain
Sponsors and Collaborators
Corporacion Parc Tauli
Investigators
Principal Investigator: Anna Rodriguez-Pont, MD Corporacio Sanitaria Parc Tauli

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anna Rodriguez Pont, MD, Corporacion Parc Tauli
ClinicalTrials.gov Identifier: NCT01171612     History of Changes
Other Study ID Numbers: CIR2009017
First Posted: July 28, 2010    Key Record Dates
Results First Posted: November 25, 2013
Last Update Posted: April 7, 2016
Last Verified: March 2016

Keywords provided by Anna Rodriguez Pont, Corporacion Parc Tauli:
Coronary Stent
BMS stent
DES stent
Date of stent implantation
cardiac event
neurovascular event
Bleeding
transfusion

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases