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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anna Rodriguez Pont, Corporacion Parc Tauli
ClinicalTrials.gov Identifier:
NCT01171612
First received: July 23, 2010
Last updated: September 16, 2013
Last verified: September 2013
  Purpose

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
Acute Coronary Syndrome
Coronary Stent Occlusion
Surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation and Monitoring of Perioperative Management of Patients With Coronary Stents Undergoing Noncardiac Surgery

Further study details as provided by Corporacion Parc Tauli:

Primary Outcome Measures:
  • Major Adverse Cardiac and Cerebrovascular Events (MACCEs) [ Time Frame: up to 90 days after surgery ] [ Designated as safety issue: Yes ]
    Cardiac Mortality, Myocardial Infarction, Angina Pectoris, new arrythmia, Congestive Heart Failure, Stroke, Cardiac Arrest


Secondary Outcome Measures:
  • Major Haemorrhagic Events [ Time Frame: up to 90 days after surgery ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]

    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


Enrollment: 483
Study Start Date: June 2009
Study Completion Date: July 2012
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Coronary Stent
Patients with coronary Bare Metal Stent (BMS) or Drug Eluting Stent (DES) undergoing noncardiac surgery

Detailed Description:

(Not desired)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Parc de Salut Mar-Esperança
Barcelona, Spain
Hospital Clínic
Barcelona, Spain
Parc de Salut Mar
Barcelona, Spain
Fundació Puigvert - IUNA
Barcelona, Spain
Sponsors and Collaborators
Corporacion Parc Tauli
Investigators
Principal Investigator: Anna Rodriguez-Pont, MD Corporacio Sanitaria Parc Tauli
  More Information

Additional Information:
No publications provided

Responsible Party: Anna Rodriguez Pont, MD, Corporacion Parc Tauli
ClinicalTrials.gov Identifier: NCT01171612     History of Changes
Other Study ID Numbers: CIR2009017
Study First Received: July 23, 2010
Results First Received: August 13, 2013
Last Updated: September 16, 2013
Health Authority: Spain: Ethics Committee

Keywords provided by 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
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Heart Diseases
Myocardial Ischemia
Pain
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014