Coronary Artery DiseaseNCT00712153
Follow-up of Coronary Artery Bypass Graft Patency by Multislice Computed Tomography
An observational study of Coronary Artery Disease, run by Far Eastern Memorial Hospital.
Trial summary
Coronary artery disease is a major cause of morbidity and mortality across the world and coronary artery bypass surgery (CABG) is the most common surgical procedure for treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Nov 2006to Nov 2007
- 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 underwent CABG and performed MSCT after the surgeries
Who may be able to join
- Patients underwent CABG and performed MSCT after the surgeries
Who cannot join
- Nil
About this study
Coronary artery disease is a major cause of morbidity and mortality across the world and coronary artery bypass surgery (CABG) is the most common surgical procedure for treatment. Patients with recurrent ischemic symptoms after CABG are most likely to have occluded or significantly stenosis in grafts or native coronary arteries. Therefore, there is a need to evaluate the patency of these vessel conduits after CABG. Until now, selective coronary angiography is the traditional gold standard for the assessment of both native coronary arteries and bypass grafts. But it is an invasive procedure that requires x-ray exposure, hospitalization, and includes a risk for complication. However, there is an alternative noninvasive method, multislice computed tomography (MSCT), with high specificity and excellent sensitivity for the detection of the coronary artery disease. It is even cheaper and takes shorter time to perform. Accordingly, the purpose of this study is to use MSCT to evaluate the patency and the quality of all grafts and native coronary arteries after CABG for more than two years. In addition, we will elucidate the relationship of these data and CABG procedures to review our experience.
- Conditions
- Coronary Artery Disease
- Keywords
- multislice computed tomography, coronary artery bypass grafting, Patients, underwent, surgeries
- Medical subject headings
- Coronary Artery Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2008 (estimated)
- Study startNov 2006
- Primary completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00712153
- Sponsor's protocol ID
- 95023
- Other IDs
- FEMH - 95 - D -001
- Status last verified
- Jul 2008
- First submitted
- 7 Jul 2008
- Last updated
- 9 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up of Coronary Artery Bypass Graft Patency by Multislice Computed Tomography
- ClinicalTrials.gov ID
- NCT00712153
- Acronym / sponsor ID
- 95023
- Conditions
- Coronary Artery Disease
- Keywords
- multislice computed tomography, coronary artery bypass grafting, Patients, underwent, surgeries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Nov 2007 (actual)
- First posted
- 9 Jul 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.
Coronary artery disease is a major cause of morbidity and mortality across the world and coronary artery bypass surgery (CABG) is the most common surgical procedure for treatment. Patients with recurrent ischemic symptoms after CABG are most likely to have occluded or significantly stenosis in grafts or native coronary arteries. Therefore, there is a need to evaluate the patency of these vessel conduits after CABG. Until now, selective coronary angiography is the traditional gold standard for the assessment of both native coronary arteries and bypass grafts. But it is an invasive procedure that requires x-ray exposure, hospitalization, and includes a risk for complication. However, there is an alternative noninvasive method, multislice computed tomography (MSCT), with high specificity and excellent sensitivity for the detection of the coronary artery disease. It is even cheaper and takes shorter time to perform. Accordingly, the purpose of this study is to use MSCT to evaluate the patency and the quality of all grafts and native coronary arteries after CABG for more than two years. In addition, we will elucidate the relationship of these data and CABG procedures to review our experience.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients underwent CABG and performed MSCT after the surgeries
Key inclusion criteria (1 listed)
- Patients underwent CABG and performed MSCT after the surgeries
Key exclusion criteria (1 listed)
- Nil
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 9 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Far Eastern Memorial Hospital.
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 1 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 9 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
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 9 Aug 2010.