Prognostic Assessment of Different Pattern of Bifurcation Restenosis (LATINA)

February 21, 2020 updated by: Gregory Sgueglia, MD, Ospedale Santa Maria Goretti

Classification of Bifurcation Restenosis: a Prognostic Assessment

The LATINA registry aims at assessing a new classification of bifurcation restenosis in the prediction of major adverse cardiac events in patients who have previously undergone a succesful percutaneous bifurcation intervention.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

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

Study Locations

  • Italy
      • Latina, Italy
        • S.M. Goretti
      • Latina, Italy, 04100
        • S.M. Goretti

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

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Coronary artery disease

Description

Inclusion Criteria:

  • age >18 years
  • restenosis involving a coronary bifurcation previously treated percutaneously

Exclusion Criteria:

  • life expectancy >1 year

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Bifurcation restenosis
Patients with either a main vessel or a side branch restenosis following succesful percutaneous coronary intervention
Other: Bifurcation restenosis classification
Classification of restenosis involving coronary bifurcation according to their pattern

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiac events
Time Frame: 12 months
Number of patients experiencing any of the following events: cardiac death, non-fatal miocardial infarction, target vessel revascularization
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac death
Time Frame: 12
Number of patients experiencing a cardiac death event
12
Non-fatal myocardial infarction
Time Frame: 12 months
Number of patients experiencing a non-fatal myocardial infarction event
12 months
Target vessel revascularization
Time Frame: 12 month
Number of patients experiencing a target vessel revascularization event
12 month

Collaborators and Investigators

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

Sponsor

Ospedale Santa Maria Goretti

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2011

Primary Completion (Anticipated)

August 1, 2011

Study Completion (Anticipated)

August 1, 2012

Study Registration Dates

First Submitted

August 5, 2011

First Submitted That Met QC Criteria

August 5, 2011

First Posted (Estimate)

August 8, 2011

Study Record Updates

Last Update Posted (Actual)

February 25, 2020

Last Update Submitted That Met QC Criteria

February 21, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMG-009

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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