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Italian Registry on Unprotected Left Main (RITMO)

This study is currently recruiting participants.
Verified February 2010 by University of Turin, Italy
Sponsor:
Information provided by:
University of Turin, Italy
ClinicalTrials.gov Identifier:
NCT00612053
First received: January 29, 2008
Last updated: June 28, 2010
Last verified: February 2010
History of Changes
  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)

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • major adverse cerebro-cardiovascular events [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]
  • Canadian Cardiac Society functional class [ Time Frame: 60 months ] [ Designated as safety issue: No ]
  • quality of life (EuroQoL) [ Time Frame: 60 months ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: January 29, 2008
Last Updated: June 28, 2010
Health Authority: Italy: Ministry of Health

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

ClinicalTrials.gov processed this record on May 19, 2013