Italian Registry on Unprotected Left Main

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00612053

Acronym

RITMO

Enrollment

1200

Registered

2008-02-11

Start date

2008-05-31

Completion date

2015-12-31

Last updated

2010-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease, Coronary Artery Disease

Keywords

cardiovascular disease, coronary artery bypass grafting (CABG), coronary artery disease (CAD), percutaneous transluminal coronary angioplasty (PCI), unprotected left main disease

Brief 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.

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
major adverse cerebro-cardiovascular events (ie death, myocardial infarction, stroke, or coronary revascularization)	12 months

Secondary

Measure	Time frame
major adverse cerebro-cardiovascular events	60 months
Canadian Cardiac Society functional class	60 months
quality of life (EuroQoL)	60 months

Countries

Italy

Contacts

Primary ContactGiuseppe Biondi Zoccai, MD

gbiondizoccai@gmail.com

Outcome results