Italian Registry on Unprotected Left Main - Full Text View

Sponsored by:	University of Turin, Italy
Information provided by:	University of Turin, Italy
ClinicalTrials.gov Identifier:	NCT00612053

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

MedlinePlus related topics: Coronary Artery Disease

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, 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 ] [ 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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	1200
Study Start Date:	May 2008
Estimated Study Completion Date:	March 2014
Estimated Primary Completion Date:	March 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, To
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

Responsible Party:	University of Turin ( Giuseppe Biondi Zoccai, Assistant Professor in Cardiology )
Study ID Numbers:	CEI/167
Study First Received:	January 29, 2008
Last Updated:	June 17, 2008
ClinicalTrials.gov Identifier:	NCT00612053
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

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 13, 2009