Register of Treatment of Unprotected Left Main Coronary Artery Stenosis in Andalucía (RETRATO)

August 4, 2015 updated by: Fundación Pública Andaluza Progreso y Salud

Multicenter, Prospective, Observational Study of of Treatment of Unprotected Left Main Coronary Artery Stenosis in Andalucía

Register of treatment of unprotected left main coronary artery stenosis in Andalucia (RETRATO).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

315

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Almería, Spain
        • Recruiting
        • Hospital Torrecardenas
        • Contact:
          • Félix Valencia Serrano
      • Granada, Spain
        • Recruiting
        • Hospital Universitario Virgen de Las Nieves
        • Contact:
          • Norberto Herrera Gómez
      • Granada, Spain
        • Recruiting
        • Hospital Universitario San Cecilio
        • Contact:
          • Juan Caballero Borrego
      • Huelva, Spain
        • Recruiting
        • Hospital Juan Ramón Jimenez
        • Contact:
          • Jessica Roa Garrido
      • Málaga, Spain
        • Recruiting
        • Hospital Carlos Haya
        • Contact:
          • Carlos Sánchez González
      • Málaga, Spain
        • Recruiting
        • Hospital Clinico Universitario Virgen de la Victoria
        • Contact:
          • Antonio Jesús Muñoz García

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients with unprotected left main coronary artery stenosis in Andalucia who can follow a year monitoring in participating centers

Description

Inclusion Criteria:

  • New diagnosed of unprotected left main coronary artery stenosis (lesion ≥50%)
  • Have signed informed consent

Exclusion Criteria:

  • Participating in other research protocol
  • Inability to follow a monitoring

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Unprotected left main coronary artery stenosis patients
Procedure: Coronary stent procedure (CSP)
Procedure: Coronary-artery bypass grafting (CABG)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure the MACE survival in the coronary-artery bypass grafting (CABG) group and in the coronary stent procedure (CSP) group, to identify the differences between both groups in the short and medium-term follow up
Time Frame: 12 months
MACE= Major Adverse Cardiac Event (e.g., acute myocardial infarction, ischaemic stroke, coronary arterial occlusion, death)
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Pública Andaluza Progreso y Salud

Investigators

  • Principal Investigator: Carlos Sánchez González, Hospital Carlos Haya

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

May 1, 2016

Study Registration Dates

First Submitted

October 18, 2013

First Submitted That Met QC Criteria

October 23, 2013

First Posted (Estimate)

October 29, 2013

Study Record Updates

Last Update Posted (Estimate)

August 5, 2015

Last Update Submitted That Met QC Criteria

August 4, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSG-TCI-2012-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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