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Italian Registry on Unprotected Left Main (RITMO)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2010 by University of Turin, Italy.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00612053
First Posted: February 11, 2008
Last Update Posted: June 29, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Turin, Italy
  Purpose
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.

Condition
Cardiovascular Disease Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Italian Registry on Treatment for Unprotected Left Main Disease (Registro Italiano Sul Trattamento Del Tronco coMune Non protettO)

Further study details as provided by University of Turin, Italy:

Primary Outcome Measures:
  • major adverse cerebro-cardiovascular events (ie death, myocardial infarction, stroke, or coronary revascularization) [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • major adverse cerebro-cardiovascular events [ Time Frame: 60 months ]
  • Canadian Cardiac Society functional class [ Time Frame: 60 months ]
  • quality of life (EuroQoL) [ Time Frame: 60 months ]

Estimated Enrollment: 1200
Study Start Date: May 2008
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
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).
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with suspected coronary artery disease undergoing diagnostic coronary angiography.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00612053


Contacts
Contact: Giuseppe Biondi Zoccai, MD gbiondizoccai@gmail.com

Locations
Italy
Division of Cardiology, University of Turin Recruiting
Turin, To, Italy, 10126
Contact: Giuseppe Biondi Zoccai, MD    +39-011-6334195    gbiondizoccai@gmail.com   
Sponsors and Collaborators
University of Turin, Italy
Investigators
Principal Investigator: Giuseppe Biondi Zoccai, MD University of Turin, Italy
  More Information

Responsible Party: Giuseppe Biondi Zoccai, Assistant Professor in Cardiology, University of Turin
ClinicalTrials.gov Identifier: NCT00612053     History of Changes
Other Study ID Numbers: CEI/167
First Submitted: January 29, 2008
First Posted: February 11, 2008
Last Update Posted: June 29, 2010
Last Verified: February 2010

Keywords provided by University of Turin, Italy:
cardiovascular disease
coronary artery bypass grafting (CABG)
coronary artery disease (CAD)
percutaneous transluminal coronary angioplasty (PCI)
unprotected left main disease

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases