Italian Registry on Unprotected Left Main (RITMO)

June 28, 2010 updated by: University of Turin, Italy

Italian Registry on Treatment for Unprotected Left Main Disease (Registro Italiano Sul Trattamento Del Tronco coMune Non protettO)

The RITMO (Registro Italiano sul trattamento del Tronco coMune non protettO) observational study will appraise the prevalence, management strategy, and prognosis of unprotected left main coronary artery disease in Italy.

Study Overview

Status

Unknown

Conditions

Detailed Description

The RITMO (Registro Italiano sul trattamento del Tronco coMune non protettO) observational study will be a prospective, multicenter, observational study aiming to appraise the prevalence, management strategy, and prognosis (up to 5 years) of unprotected left main coronary artery disease in Italy. A total of 45 Italian secondary and tertiary care centers will participate, and enroll patients during a period of 12 to 18 months. Patients will be included provided that they complete a written informed consent form and significant unprotected left main coronary artery disease is established at diagnostic coronary angiography. The primary end-point will be the 12-month rate of major adverse cerebro-cardiovascular events (ie death, myocardial infarction, stroke, or coronary revascularization).

Study Type

Observational

Enrollment (Anticipated)

1200

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
    • To
      • Turin, To, Italy, 10126
        • Recruiting
        • Division of Cardiology, University of Turin
        • Contact:

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with suspected coronary artery disease undergoing diagnostic coronary angiography.

Description

Inclusion Criteria:

  • angiographic evidence of significant unprotected left main disease
  • lack of patent bypass grafts for the left coronary system
  • willingness to complete written informed consent form
  • willingness to comply with subsequent follow-up contacts

Exclusion Criteria:

  • lack of written informed consent form
  • inability to comply with subsequent follow-up contacts

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
major adverse cerebro-cardiovascular events (ie death, myocardial infarction, stroke, or coronary revascularization)
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
major adverse cerebro-cardiovascular events
Time Frame: 60 months
60 months
Canadian Cardiac Society functional class
Time Frame: 60 months
60 months
quality of life (EuroQoL)
Time Frame: 60 months
60 months

Collaborators and Investigators

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

Sponsor

University of Turin, Italy

Investigators

  • Principal Investigator: Giuseppe Biondi Zoccai, MD, University of Turin, Italy

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

May 1, 2008

Primary Completion (Anticipated)

December 1, 2009

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

January 29, 2008

First Submitted That Met QC Criteria

January 29, 2008

First Posted (Estimate)

February 11, 2008

Study Record Updates

Last Update Posted (Estimate)

June 29, 2010

Last Update Submitted That Met QC Criteria

June 28, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEI/167

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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