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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 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: April 28, 2014
Last verified: April 2014
  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
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: 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: April 28, 2014
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 August 27, 2014