Italian Registry on Unprotected Left Main

NCT ID: NCT00612053

Last Updated: 2010-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-05-31

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Cardiovascular Disease Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Turin, Italy

OTHER

Sponsor Role lead

Responsible Party

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University of Turin

Principal Investigators

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Giuseppe Biondi Zoccai, MD

Role: PRINCIPAL_INVESTIGATOR

University of Turin, Italy

Locations

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Division of Cardiology, University of Turin

Turin, To, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Giuseppe Biondi Zoccai, MD

Role: CONTACT

Facility Contacts

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Giuseppe Biondi Zoccai, MD

Role: primary

+39-011-6334195

Other Identifiers

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CEI/167

Identifier Type: -

Identifier Source: org_study_id

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