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NCT00612053 Clinical Trial

Italian Registry on Unprotected Left Main

Coronary Artery Disease Clinical Trial

— RITMO  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00612053
Other study ID # CEI/167
Secondary ID
Status Recruiting
Phase N/A
First received January 29, 2008
Last updated June 28, 2010
Start date May 2008
Est. completion date December 2015

Study information
Verified date February 2010
Source University of Turin, Italy
Contact Giuseppe Biondi Zoccai, MD
Email gbiondizoccai@gmail.com
Is FDA regulated No
Health authority Italy: Ministry of Health
Study type Observational

Clinical Trial Summary

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.

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).

Recruitment information / eligibility
Status Recruiting
Enrollment 1200
Est. completion date December 2015
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Italy Division of Cardiology, University of Turin Turin To

Sponsors (1)
Lead Sponsor Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary major adverse cerebro-cardiovascular events (ie death, myocardial infarction, stroke, or coronary revascularization) 12 months Yes
Secondary major adverse cerebro-cardiovascular events 60 months Yes
Secondary Canadian Cardiac Society functional class 60 months No
Secondary quality of life (EuroQoL) 60 months No
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