NCT01971749

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
315

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2013

Typical duration for all trials

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 29, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

August 5, 2015

Status Verified

August 1, 2015

Enrollment Period

2.6 years

First QC Date

October 18, 2013

Last Update Submit

August 4, 2015

Conditions

Keywords

Coronary stent procedure (CSPCoronary-artery bypass grafting (CABG)

Outcome Measures

Primary Outcomes (1)

  • 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

    MACE= Major Adverse Cardiac Event (e.g., acute myocardial infarction, ischaemic stroke, coronary arterial occlusion, death)

    12 months

Study Arms (1)

Unprotected left main coronary artery stenosis patients

Procedure: Coronary stent procedure (CSP)Procedure: Coronary-artery bypass grafting (CABG)

Interventions

Unprotected left main coronary artery stenosis patients
Unprotected left main coronary artery stenosis patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hospital Torrecárdenas

Almería, Spain

RECRUITING

Hospital Universitario San Cecilio

Granada, Spain

RECRUITING

Hospital Universitario Virgen de las Nieves

Granada, Spain

RECRUITING

Hospital Juan Ramón Jiménez

Huelva, Spain

RECRUITING

Hospital Carlos Haya

Málaga, Spain

RECRUITING

Hospital Clínico Universitario Virgen de la Victoria

Málaga, Spain

RECRUITING

MeSH Terms

Interventions

Coronary Artery Bypass

Intervention Hierarchy (Ancestors)

Myocardial RevascularizationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeVascular GraftingVascular Surgical ProceduresThoracic Surgical Procedures

Study Officials

  • Carlos Sánchez González

    Hospital Carlos Haya

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlos Sánchez González

CONTACT

María del Mar Benjumea Vargas

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2013

First Posted

October 29, 2013

Study Start

May 1, 2013

Primary Completion

December 1, 2015

Study Completion

May 1, 2016

Last Updated

August 5, 2015

Record last verified: 2015-08

Locations