Cardiovascular DiseaseRITMONCT00612053
Italian Registry on Unprotected Left Main
An observational study of Cardiovascular Disease and Coronary Artery Disease, run by University of Turin, Italy at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Disease, Coronary Artery Disease
- How many people
- 1,200 participants
- Where
- 1 siteItaly
- Study dates
- May 2008to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with suspected coronary artery disease undergoing diagnostic coronary angiography.
Who may be able to join
- 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
Who cannot join
- lack of written informed consent form
- inability to comply with subsequent follow-up contacts
Trial locations and contacts
1 site in 1 country.
Giuseppe Biondi Zoccai, MD contact
Italy1 site, 1 recruiting
- Recruiting
Division of Cardiology, University of Turin
Turin, To, 10126
Giuseppe Biondi Zoccai, MD, +39-011-6334195, gbiondizoccai@gmail.com
About this study
Official title: Italian Registry on Treatment for Unprotected Left Main Disease (Registro Italiano Sul Trattamento Del Tronco coMune Non protettO)
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.
Read the 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).
- 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
- Medical subject headings
- Cardiovascular Diseases, Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
major adverse cerebro-cardiovascular events (ie death, myocardial infarction, stroke, or coronary revascularization)
Measured: 12 months
Secondary outcomes (3)
major adverse cerebro-cardiovascular events
Measured: 60 months
Canadian Cardiac Society functional class
Measured: 60 months
quality of life (EuroQoL)
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2008 (estimated)
- Study startMay 2008
- Primary completionDec 2009 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Investigators
- Giuseppe Biondi Zoccai, MD, Principal investigator, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00612053
- Sponsor's protocol ID
- CEI/167
- Acronym
- RITMO
- Status last verified
- Feb 2010
- First submitted
- 29 Jan 2008
- Last updated
- 29 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Italian Registry on Treatment for Unprotected Left Main Disease (Registro Italiano Sul Trattamento Del Tronco coMune Non protettO)
- ClinicalTrials.gov ID
- NCT00612053
- Acronym / sponsor ID
- RITMO / CEI/167
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 11 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with suspected coronary artery disease undergoing diagnostic coronary angiography.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- lack of written informed consent form
- inability to comply with subsequent follow-up contacts
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
major adverse cerebro-cardiovascular events (ie death, myocardial infarction, stroke, or coronary revascularization)
Time frame: 12 months
3 secondary outcomes
major adverse cerebro-cardiovascular events
Time frame: 60 months
Canadian Cardiac Society functional class
Time frame: 60 months
quality of life (EuroQoL)
Time frame: 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe Biondi Zoccai, MD contact
Giuseppe Biondi Zoccai, MD principal investigator
University of Turin, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Disease and Coronary Artery Disease, run by University of Turin, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe Biondi Zoccai, MD (gbiondizoccai@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
major adverse cerebro-cardiovascular events (ie death, myocardial infarction, stroke, or coronary revascularization) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2010.