Coronary ArteriosclerosisNCT00113451
Radial Artery Bypass Graft Study of Tromsø
An observational study of Coronary Arteriosclerosis and Myocardial Infarction, run by University Hospital of North Norway at 1 site in Norway.
Trial summary
The purpose of this study is to answer, among others, the following questions: 1) What are the outcomes when using the radial artery as a bypass graft in coronary artery bypass surgery (CABG)? 2) Can multidetector computed tomography (CT) be used to reliably evaluate coronary artery bypass graft patency? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Arteriosclerosis, Myocardial Infarction
- How many people
- 119 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2004to May 2005
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Operated with radial artery coronary bypass at our department during April 2001 - October 2004
- Written informed consent
Who cannot join
- For the angiography procedures, standard contraindications are adhered to
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to answer, among others, the following questions: 1) What are the outcomes when using the radial artery as a bypass graft in coronary artery bypass surgery (CABG)? 2) Can multidetector computed tomography (CT) be used to reliably evaluate coronary artery bypass graft patency?
Read the detailed description
Radial arteries have been used as aortocoronary conduits with varying results. The study is based on the first 119 patients operated with this graft at our institution, aiming to answer the following questions:
- What is the short-term patency (2-3 years) of radial artery bypass grafts in CABG (comparisons are made with saphenous veins and internal thoracic artery grafts)?
- What complications occur and what in what frequency?
- What are the clinical outcomes and patient satisfaction after using radial arteries in CABG? (n=119 pt.)
- Can multidetector CT be used to reliably evaluate coronary artery bypass graft patency? (n=45 pt.)
Methods: Questionnaires, record review, coronary angiography.
- Conditions
- Coronary Arteriosclerosis, Myocardial Infarction
- Keywords
- radial artery, angina pectoris, infarction, bypass, angiography
- Medical subject headings
- Coronary Artery Disease, Myocardial Infarction, Angina Pectoris, Infarction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2005 (estimated)
- Study startJan 2004
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary ArteriosclerosisStudies 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
- Defined population
- Time perspective
- Prospective
- Enrolment
- 119 participants
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00113451
- Sponsor's protocol ID
- SFP-091-03
- Other IDs
- P-REK Nord 82/2003
- Status last verified
- Jun 2005
- First submitted
- 7 Jun 2005
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radial Artery Bypass Graft Study of Tromsø
- ClinicalTrials.gov ID
- NCT00113451
- Acronym / sponsor ID
- SFP-091-03
- Conditions
- Coronary Arteriosclerosis, Myocardial Infarction
- Keywords
- radial artery, angina pectoris, infarction, bypass, angiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Study start
- Jan 2004
- Study completion
- May 2005
- First posted
- 8 Jun 2005 (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 purpose of this study is to answer, among others, the following questions: 1) What are the outcomes when using the radial artery as a bypass graft in coronary artery bypass surgery (CABG)? 2) Can multidetector computed tomography (CT) be used to reliably evaluate coronary artery bypass graft patency?
Detailed description
Radial arteries have been used as aortocoronary conduits with varying results. The study is based on the first 119 patients operated with this graft at our institution, aiming to answer the following questions:
- What is the short-term patency (2-3 years) of radial artery bypass grafts in CABG (comparisons are made with saphenous veins and internal thoracic artery grafts)?
- What complications occur and what in what frequency?
- What are the clinical outcomes and patient satisfaction after using radial arteries in CABG? (n=119 pt.)
- Can multidetector CT be used to reliably evaluate coronary artery bypass graft patency? (n=45 pt.)
Methods: Questionnaires, record review, coronary angiography.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Operated with radial artery coronary bypass at our department during April 2001 - October 2004
- Written informed consent
Key exclusion criteria (1 listed)
- For the angiography procedures, standard contraindications are adhered to
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Coronary Arteriosclerosis and Myocardial Infarction, run by University Hospital of North Norway at 1 site in Norway.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 24 Jun 2005. 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 Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 24 Jun 2005.