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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Corporacion Parc Tauli.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Corporacion Parc Tauli
ClinicalTrials.gov Identifier:
NCT01171612
First received: July 23, 2010
Last updated: August 2, 2011
Last verified: December 2009
History of Changes
  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 Events (MACEs) [ Time Frame: up to 90 days after surgery ] [ Designated as safety issue: Yes ]
    Cardiac Mortality, Myocardial Infarction, Angor Pectoris


Secondary Outcome Measures:
  • Minor Cardiac Events [ Time Frame: up to 90 days after surgery ] [ Designated as safety issue: Yes ]
    Hypotension, Hypertension, Arrythmia, Cardiac events management

  • Neurovascular events. [ Time Frame: up to 90 days after surgery ] [ Designated as safety issue: No ]
    Stroke, Transient Ischaemic Attack

  • Bleeding [ Time Frame: up to 30 days after surgery ] [ Designated as safety issue: Yes ]
    Haemoglobin levels, Transfusion

  • Number of patients with adverse events related with Antiplatelet Therapy management [ Time Frame: 90 days after surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 500
Study Start Date: June 2009
Estimated Study Completion Date: March 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
  • ASA II-V
  • noncardiac surgery wiht admission
  • informed consent

Exclusion Criteria:

  • < 18 years old
  • ASA I
  • ambulatory surgery
  • pregnancy
  • obstetric anaesthesia
  • endoscopic procedures
  • cardiac surgery
  • not informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01171612

Contacts
Contact: Anna Rodriguez-Pont 0034696485681 25836arp@comb.cat

Locations
Spain
Hospital Municipal de Badalona Recruiting
Badalona, Barcelona, Spain
Contact: Fernando Rey         frey@bsa.cat    
Hospital Germans Trias i Pujol Recruiting
Badalona, Barcelona, Spain
Contact: Esther Martinez         stherma4@yahoo.es    
Hospital Igualada Recruiting
Igualada, Barcelona, Spain
Contact: Diana Marcela Lopez         dlopez@csa.cat    
Hospital de Mataró Recruiting
Mataró, Barcelona, Spain
Contact: Maddalena Pasini         maddalena_pasini@yahoo.it    
Hospital de Sabadell. Corporació Sanitària Parc Taulí Recruiting
Sabadell, Barcelona, Spain, 08208
Contact: Anna Rodriguez-Pont, MD     0034696485681     25836arp@comb.cat    
Principal Investigator: Anna Rodriguez-Pont, MD            
Sub-Investigator: Nuria Guilera, MD            
Hospital de Sant Celoni Recruiting
Sant Celoni, Barcelona, Spain
Contact: Elisabet Hansen, MD         24259ehf@comb.cat    
Clínica ASEPEYO Recruiting
Sant Cugat del Valles, Barcelona, Spain
Contact: Antoni Prat         apratvallribera@asepeyo.es    
Hospital Sant Joan Despi Moisès Broggi Recruiting
Sant Joan Despi, Barcelona, Spain
Contact: Rosario Armand         armandugon@hotmail.com    
Parc de Salut Mar-Esperança Recruiting
Barcelona, Spain
Contact: Jorge Castillo         jcastillo@parcdesalutmar.cat    
Fundació Puigvert - IUNA Recruiting
Barcelona, Spain
Contact: Pilar Sierra Arnedo, MD         psierraa@gmail.com    
Hospital Clínic Recruiting
Barcelona, Spain
Contact: Guillermina Fita         GFITA@clinic.ub.es    
Parc de Salut Mar Recruiting
Barcelona, Spain
Contact: Anna Mases, MD         amases@parcdesalutmar.cat    
Sponsors and Collaborators
Corporacion Parc Tauli
Investigators
Principal Investigator: Anna Rodriguez-Pont, MD Corporacio Sanitaria Parc Tauli
  More Information

Additional Information:
study recruitment web page  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Anna Rodríguez-Pont, Hospital de Sabadell
ClinicalTrials.gov Identifier: NCT01171612     History of Changes
Other Study ID Numbers: CIR2009017
Study First Received: July 23, 2010
Last Updated: August 2, 2011
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
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
 Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 17, 2012