NCT00612053

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 11, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

June 29, 2010

Status Verified

February 1, 2010

Enrollment Period

1.6 years

First QC Date

January 29, 2008

Last Update Submit

June 28, 2010

Conditions

Cardiovascular DiseaseCoronary Artery Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • major adverse cerebro-cardiovascular events (ie death, myocardial infarction, stroke, or coronary revascularization)

    12 months

Secondary Outcomes (3)

  • major adverse cerebro-cardiovascular events

    60 months

  • Canadian Cardiac Society functional class

    60 months

  • quality of life (EuroQoL)

    60 months

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with suspected coronary artery disease undergoing diagnostic coronary angiography.

You may qualify if:

  • 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

You may not qualify if:

  • lack of written informed consent form
  • inability to comply with subsequent follow-up contacts

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Cardiology, University of Turin

Turin, To, 10126, Italy

RECRUITING

MeSH Terms

Conditions

Cardiovascular DiseasesCoronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Giuseppe Biondi Zoccai, MD

    University of Turin, Italy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Giuseppe Biondi Zoccai, MD

CONTACT

gbiondizoccai@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 29, 2008

First Posted

February 11, 2008

Study Start

May 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2015

Last Updated

June 29, 2010

Record last verified: 2010-02

Locations

IT(1)