Unprotected Left Main Coronary Artery StenosisRETRATONCT01971749
Register of Treatment of Unprotected Left Main Coronary Artery Stenosis in Andalucía
An observational study of Unprotected Left Main Coronary Artery Stenosis, run by Fundación Pública Andaluza Progreso y Salud at 6 sites in Spain.
Trial summary
Register of treatment of unprotected left main coronary artery stenosis in Andalucia (RETRATO). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Unprotected Left Main Coronary Artery Stenosis
- What is being tested?
- Coronary stent procedure (CSP) and Coronary-artery bypass grafting (CABG)
- Type of treatment
- Surgery or procedure
- How many people
- 315 participants
- Where
- 6 sitesSpain
- Study dates
- May 2013to May 2016
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Consecutive patients with unprotected left main coronary artery stenosis in Andalucia who can follow a year monitoring in participating centers
Who may be able to join
- New diagnosed of unprotected left main coronary artery stenosis (lesion ≥50%)
- Have signed informed consent
Who cannot join
- Participating in other research protocol
- Inability to follow a monitoring
Trial locations and contacts
6 sites in 1 country.
Carlos Sánchez González contact
María del Mar Benjumea Vargas contact
6 sites in 1 country
Spain6 sites, 6 recruiting
- Recruiting
Hospital Torrecárdenas
Almería
Félix Valencia Serrano
- Recruiting
Hospital Universitario San Cecilio
Granada
Juan Caballero Borrego
- Recruiting
Hospital Universitario Virgen de las Nieves
Granada
Norberto Herrera Gómez
- Recruiting
Hospital Juan Ramón Jiménez
Huelva
Jessica Roa Garrido
- Recruiting
Hospital Carlos Haya
Málaga
Carlos Sánchez González
- Recruiting
Hospital Clínico Universitario Virgen de la Victoria
Málaga
Antonio Jesús Muñoz García
About this study
Official title: 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).
- Being tested
- Coronary stent procedure (CSP), Coronary-artery bypass grafting (CABG)
- Keywords
- Coronary stent procedure (CSP, Coronary-artery bypass grafting (CABG)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary stent procedure (CSP)Procedure or surgery
Coronary-artery bypass grafting (CABG)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Unprotected left main coronary artery stenosis patients | Not described Receives: Procedure: Coronary stent procedure (CSP); Procedure: Coronary-artery bypass grafting (CABG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2015 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unprotected Left Main Coronary Artery StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 315 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza Progreso y Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos Sánchez González, Principal investigator, Hospital Carlos Haya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01971749
- Sponsor's protocol ID
- CSG-TCI-2012-01
- Acronym
- RETRATO
- Status last verified
- Aug 2015
- First submitted
- 18 Oct 2013
- Last updated
- 5 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Prospective, Observational Study of of Treatment of Unprotected Left Main Coronary Artery Stenosis in Andalucía
- ClinicalTrials.gov ID
- NCT01971749
- Acronym / sponsor ID
- RETRATO / CSG-TCI-2012-01
- Keywords
- Coronary stent procedure (CSP, Coronary-artery bypass grafting (CABG)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 315 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza Progreso y SaludUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 29 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Register of treatment of unprotected left main coronary artery stenosis in Andalucia (RETRATO).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unprotected left main coronary artery stenosis patients | – | Procedure: Coronary stent procedure (CSP), Procedure: Coronary-artery bypass grafting (CABG) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive patients with unprotected left main coronary artery stenosis in Andalucia who can follow a year monitoring in participating centers
Key inclusion criteria (2 listed)
- New diagnosed of unprotected left main coronary artery stenosis (lesion ≥50%)
- Have signed informed consent
Key exclusion criteria (2 listed)
- Participating in other research protocol
- Inability to follow a monitoring
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary stent procedure (CSP) | Procedure or surgery | Unprotected left main coronary artery stenosis patients |
| Coronary-artery bypass grafting (CABG) | Procedure or surgery | Unprotected left main coronary artery stenosis patients |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Sánchez González contact
María del Mar Benjumea Vargas contact
Carlos Sánchez González principal investigator
Hospital Carlos Haya
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unprotected Left Main Coronary Artery Stenosis, run by Fundación Pública Andaluza Progreso y Salud at 6 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlos Sánchez González (coxybum@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2015.