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Prognostic Assessment of Different Pattern of Bifurcation Restenosis (LATINA)

This study is currently recruiting participants.
Verified August 2011 by Ospedale Santa Maria Goretti
Sponsor:
Information provided by:
Ospedale Santa Maria Goretti
ClinicalTrials.gov Identifier:
NCT01411475
First received: August 5, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted
  Purpose

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.


Condition Intervention
In-stent Coronary Artery Restenosis
 Other: Bifurcation restenosis classification

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Classification of Bifurcation Restenosis: a Prognostic Assessment

Further study details as provided by Ospedale Santa Maria Goretti:

Primary Outcome Measures:
  • Major adverse cardiac events [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Number of patients experiencing any of the following events: cardiac death, non-fatal miocardial infarction, target vessel revascularization


Secondary Outcome Measures:
  • Cardiac death [ Time Frame: 12 ] [ Designated as safety issue: No ]
    Number of patients experiencing a cardiac death event

  • Non-fatal myocardial infarction [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Number of patients experiencing a non-fatal myocardial infarction event

  • Target vessel revascularization [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    Number of patients experiencing a target vessel revascularization event


Estimated Enrollment: 100
Study Start Date: August 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Coronary artery disease

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • life expectancy >1 year
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01411475

Contacts
Contact: Gregory A Sgueglia, MD, PhD +3907736556217 g.a.sgueglia@gmail.com

Locations
Italy
S.M. Goretti Recruiting
Latina, Italy, 04100
Contact: Gregory A Sgueglia, MD, PhD     +3907736556217     g.a.sgueglia@gmail.com    
Contact: Daniel Todaro, MD, PhD     3907736556217     todarodaneile@gmail.com    
S.M. Goretti Recruiting
Latina, Italy
Contact: Gregory A Sgueglia, MD, PhD     +3907736556217     g.a.sgueglia@gmail.com    
Contact: Daniel Todaro, MD, PhD     3907736556217     todarodaniel@gmail.com    
Principal Investigator: Gregory A Sgueglia, MD, PhD            
Sub-Investigator: Daniel Daniel, MD, PhD            
Sponsors and Collaborators
Ospedale Santa Maria Goretti
  More Information

No publications provided

Responsible Party: Edoardo Pucci, S.M. Goretti
ClinicalTrials.gov Identifier: NCT01411475     History of Changes
Other Study ID Numbers: SMG-009
Study First Received: August 5, 2011
Last Updated: August 5, 2011
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Coronary Restenosis
Coronary Stenosis
Coronary Disease
Myocardial Ischemia
 Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013