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

This study is currently recruiting participants.
Verified October 2013 by Fundación Pública Andaluza Progreso y Salud
Sponsor:
Information provided by (Responsible Party):
Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier:
NCT01971749
First received: October 18, 2013
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention
Unprotected Left Main Coronary Artery Stenosis
Procedure: Coronary stent procedure (CSP)
Procedure: Coronary-artery bypass grafting (CABG)

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Multicenter, Prospective, Observational Study of of Treatment of Unprotected Left Main Coronary Artery Stenosis in Andalucía

Resource links provided by NLM:


Further study details as provided by Fundación Pública Andaluza Progreso y Salud:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    MACE= Major Adverse Cardiac Event (e.g., acute myocardial infarction, ischaemic stroke, coronary arterial occlusion, death)


Estimated Enrollment: 315
Study Start Date: May 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Unprotected left main coronary artery stenosis patients Procedure: Coronary stent procedure (CSP) Procedure: Coronary-artery bypass grafting (CABG)

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01971749

Contacts
Contact: Carlos Sánchez González coxybum@hotmail.com
Contact: María del Mar Benjumea Vargas gestionensayosclinicos.fps@juntadeandalucia.es

Locations
Spain
Hospital Torrecárdenas Recruiting
Almería, Spain
Contact: Félix Valencia Serrano         
Hospital Universitario Virgen de las Nieves Recruiting
Granada, Spain
Contact: Norberto Herrera Gómez         
Hospital Universitario San Cecilio Recruiting
Granada, Spain
Contact: Juan Caballero Borrego         
Hospital Juan Ramón Jiménez Recruiting
Huelva, Spain
Contact: Jessica Roa Garrido         
Hospital Clínico Universitario Virgen de la Victoria Recruiting
Málaga, Spain
Contact: Antonio Jesús Muñoz García         
Hospital Carlos Haya Recruiting
Málaga, Spain
Contact: Carlos Sánchez González         
Sponsors and Collaborators
Fundación Pública Andaluza Progreso y Salud
Investigators
Principal Investigator: Carlos Sánchez González Hospital Carlos Haya
  More Information

No publications provided

Responsible Party: Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier: NCT01971749     History of Changes
Other Study ID Numbers: CSG-TCI-2012-01
Study First Received: October 18, 2013
Last Updated: October 23, 2013
Health Authority: Spain: Ethics Committee

Keywords provided by Fundación Pública Andaluza Progreso y Salud:
Coronary stent procedure (CSP
Coronary-artery bypass grafting (CABG)

Additional relevant MeSH terms:
Constriction, Pathologic
Coronary Stenosis
Pathological Conditions, Anatomical
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014