Coronary Artery Disease Amenable to Bypass Graft SurgeryNCT00259493
Graft Patency in Beating Heart Vs. Conventional CABG Using Cardiac CT
A study testing Off-Pump Coronary Artery Bypass Graft Surgery in people with Coronary Artery Disease Amenable to Bypass Graft Surgery, run by Trillium Health Centre at 1 site in Canada.
Trial summary
The purpose of this study is to compare graft patency rates following coronary artery bypass graft surgery performed by beating heart vs. conventional techniques using cardiac CT scanning to evaluate the bypass grafts. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease Amenable to Bypass Graft Surgery
- What is being tested?
- Off-Pump Coronary Artery Bypass Graft Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 350 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2005to Oct 2007
- Phase
- Interventional
- 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
- Surgery indicated
- Patient is hemodynamically stable
- Isolated coronary artery surgery (no valve)
- No contraindications to cardiopulmonary bypass
- No previous surgery (not redo CABG)
Who cannot join
- critically ill patient with hemodynamic instability.
- concomitant cardiac procedures.
- inability to provide written informed consent.
- prior severe reaction to contrast dye :
- life-threatening anaphylactoid reactions
- cardiac dysrhythmias and arrest
Show all 10Show fewer
- cardiovascular and pulmonary collapse
- elevated serum creatinine (>150 mmol/L).
- contraindications to cardiopulmonary bypass.
- Age < 18 years .
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Trillium Health Centre
Mississauga, Ontario, L5B 1B8
About this study
Official title: Graft Patency Following Off-Pump CABG Vs. On-Pump CABG Using 64 MDCT Bypass Graft CT Angiography
The purpose of this study is to compare graft patency rates following coronary artery bypass graft surgery performed by beating heart vs. conventional techniques using cardiac CT scanning to evaluate the bypass grafts.
Read the detailed description
The issue of whether to perform conventional CABG or off-pump CABG continues to be the subject of debate. Controversy remains regarding the appropriateness of applying OPCAB to all patients as opposed to selected sub-populations.
The main strategy of CABG is to obtain complete revascularization with the least morbidity and highest long-term patency rates. Current medical literature is conflicted regarding graft patency rates in OPCAB vs. conventional CABG. Data is also limited due to patient refusal for conventional angiography to assess grafts following surgery. Cardiac computed tomography (CT) offers a non-invasive method to assess graft patency that is 100% accurate for the diagnosis of graft patency vs. occlusion. This study is a prospective randomized controlled trial evaluating graft patency in on-pump vs. off-pump CABG using cardiac CT scanning. The study hypothesis is that graft patency rates will be equivalent between the two techniques.
- Being tested
- Off-Pump Coronary Artery Bypass Graft Surgery
- Keywords
- Coronary Artery Disease, Coronary Artery Bypass Graft Surgery, Off-pump CABG, Cardiac CT, Bypass Graft CT angiography
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Off-Pump Coronary Artery Bypass Graft SurgeryProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft patency as determined by bypass graft CT angiography at 3 months and 12 months following surgery
Secondary outcomes (5)
Length of Hospital Stay
Blood Loss
Operative Time
Post-op Complications
Quality of Life Assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2005 (estimated)
- Study startDec 2005
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease Amenable to Bypass Graft SurgeryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 350 participants
Sponsor and investigators
- Lead sponsor
- Trillium Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Toshiba America Medical Systems, Inc.
- Investigators
- Tarang N Sheth, MD, FRCPC, Principal investigator, Trillium Health CentreGopal Bhatnagar, MD, FRCSC, Principal investigator, Trillium Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00259493
- Sponsor's protocol ID
- 001
- Status last verified
- Sep 2005
- First submitted
- 25 Nov 2005
- Last updated
- 11 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Graft Patency Following Off-Pump CABG Vs. On-Pump CABG Using 64 MDCT Bypass Graft CT Angiography
- ClinicalTrials.gov ID
- NCT00259493
- Acronym / sponsor ID
- 001
- Keywords
- Coronary Artery Disease, Coronary Artery Bypass Graft Surgery, Off-pump CABG, Cardiac CT, Bypass Graft CT angiography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants
- Lead sponsor
- Trillium Health CentreUniversity, hospital or other
- Collaborators
- Toshiba America Medical Systems, Inc.
- Study start
- Dec 2005
- Study completion
- Oct 2007
- First posted
- 29 Nov 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 compare graft patency rates following coronary artery bypass graft surgery performed by beating heart vs. conventional techniques using cardiac CT scanning to evaluate the bypass grafts.
Detailed description
The issue of whether to perform conventional CABG or off-pump CABG continues to be the subject of debate. Controversy remains regarding the appropriateness of applying OPCAB to all patients as opposed to selected sub-populations.
The main strategy of CABG is to obtain complete revascularization with the least morbidity and highest long-term patency rates. Current medical literature is conflicted regarding graft patency rates in OPCAB vs. conventional CABG. Data is also limited due to patient refusal for conventional angiography to assess grafts following surgery. Cardiac computed tomography (CT) offers a non-invasive method to assess graft patency that is 100% accurate for the diagnosis of graft patency vs. occlusion. This study is a prospective randomized controlled trial evaluating graft patency in on-pump vs. off-pump CABG using cardiac CT scanning. The study hypothesis is that graft patency rates will be equivalent between the two techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Surgery indicated
- Patient is hemodynamically stable
- Isolated coronary artery surgery (no valve)
- No contraindications to cardiopulmonary bypass
- No previous surgery (not redo CABG)
Key exclusion criteria (10 listed)
- critically ill patient with hemodynamic instability.
- concomitant cardiac procedures.
- inability to provide written informed consent.
- prior severe reaction to contrast dye :
- life-threatening anaphylactoid reactions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Off-Pump Coronary Artery Bypass Graft Surgery | Procedure or surgery | – |
Primary outcome
Graft patency as determined by bypass graft CT angiography at 3 months and 12 months following surgery
5 secondary outcomes
Length of Hospital Stay
Blood Loss
Operative Time
Post-op Complications
Quality of Life Assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2006.
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.
Tarang N Sheth, MD, FRCPC principal investigator
Trillium Health Centre
Gopal Bhatnagar, MD, FRCSC principal investigator
Trillium Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Off-Pump Coronary Artery Bypass Graft Surgery in people with Coronary Artery Disease Amenable to Bypass Graft Surgery, run by Trillium Health Centre at 1 site in Canada.
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 5 inclusion and 10 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 11 Sep 2006. 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 Canada. 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 Kathy Ariss, BSc, RN (416-400-4753, kariss@thc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graft patency as determined by bypass graft CT angiography at 3 months and 12 months following surgery. 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 11 Sep 2006.