Graft Patency in Beating Heart Vs. Conventional CABG Using Cardiac CT
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Coronary Artery Disease Amenable to Bypass Graft Surgery |
Procedure: Off-Pump Coronary Artery Bypass Graft Surgery |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Graft Patency Following Off-Pump CABG Vs. On-Pump CABG Using 64 MDCT Bypass Graft CT Angiography |
- Graft patency as determined by bypass graft CT angiography at 3 months and 12 months following surgery
- Length of Hospital Stay
- Blood Loss
- Operative Time
- Post-op Complications
- Quality of Life Assessment
| Estimated Enrollment: | 350 |
| Study Start Date: | December 2005 |
| Estimated Study Completion Date: | October 2007 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Surgery indicated
- Patient is hemodynamically stable
- Isolated coronary artery surgery (no valve)
- No contraindications to cardiopulmonary bypass
- No previous surgery (not redo CABG)
Exclusion Criteria:
- 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
- cardiovascular and pulmonary collapse
- elevated serum creatinine (>150 mmol/L).
- contraindications to cardiopulmonary bypass.
- Age < 18 years .
Contacts and Locations| Contact: Kathy Ariss, BSc, RN | 416-400-4753 | kariss@thc.on.ca |
| Canada, Ontario | |
| Trillium Health Centre | Recruiting |
| Mississauga, Ontario, Canada, L5B 1B8 | |
| Principal Investigator: | Tarang N Sheth, MD, FRCPC | Trillium Health Centre |
| Principal Investigator: | Gopal Bhatnagar, MD, FRCSC | Trillium Health Centre |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00259493 History of Changes |
| Other Study ID Numbers: | 001 |
| Study First Received: | November 25, 2005 |
| Last Updated: | September 7, 2006 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Trillium Health Centre:
|
Coronary Artery Disease Coronary Artery Bypass Graft Surgery Off-pump CABG Cardiac CT Bypass Graft CT angiography |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013