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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

January 29, 2008
June 28, 2010
May 2008
December 2009   (final data collection date for primary outcome measure)
major adverse cerebro-cardiovascular events (ie death, myocardial infarction, stroke, or coronary revascularization) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00612053 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Italian Registry on Unprotected Left Main
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.

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).
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients with suspected coronary artery disease undergoing diagnostic coronary angiography.
  • Cardiovascular Disease
  • Coronary Artery Disease
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1200
December 2015
December 2009   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact: Giuseppe Biondi Zoccai, MD gbiondizoccai@gmail.com
Italy
 
NCT00612053
CEI/167
Yes
Giuseppe Biondi Zoccai, Assistant Professor in Cardiology, University of Turin
University of Turin, Italy
Not Provided
Principal Investigator: Giuseppe Biondi Zoccai, MD University of Turin
University of Turin, Italy
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP