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Improving the Results of Heart Bypass Surgery Using New Approaches to Surgery and Medication (SUPERIORSVG)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Hamilton Health Sciences Corporation
Information provided by (Responsible Party):
Stephen E. Fremes, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01047449
First received: January 12, 2010
Last updated: May 8, 2014
Last verified: November 2011
  Purpose

Surgery for blocked arteries in the heart (coronary artery bypass grafting) can be accomplished using veins from the leg sewn onto the heart to provide an alternate path for blood flow, i.e. 'bypassing' the blockages. These veins themselves can block over time. This may result in part simply from the trauma from the surgery, in other words, by removing the vein from the leg and then sewing it to the heart. Another mechanism may be the abnormal metabolic processes within the body responsible for the plaque build-up of the heart arteries in the first place - this may lead to the blockages of the veins used for bypass. In the present era of heart bypass surgery, this incidence of veins blocking remains high despite advances in blood thinners and cholesterol medications. This study is designed to determine whether two new interventions may potentially reduce the incidence of blockages in the veins used for heart bypass surgery. One is a surgical technique significantly reducing the trauma associated with removing the leg vein prior to use as a bypass graft onto the heart. The second intervention is the use of a nutritional supplement before and after surgery which is composed of fish oils. The study will recruit sufficient patients to provide strong and relevant conclusions regarding both study questions. It will be highly applicable also because it will include approximately 1,550 patients from approximately 50 hospitals across many countries. We believe these techniques will result in significantly less vein blockages in patients one year after heart bypass surgery.


Condition Intervention Phase
Coronary Artery Disease
Procedure: No-touch SVG harvest vs conventional SVG harvest technique
Dietary Supplement: Fish oil supplementation vs placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Surgical and Pharmacological Novel Interventions to Improve Overall Results of Saphenous Vein Graft Patency in Coronary Artery Bypass Grafting Surgery: An International Multi-Center Randomized Controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • Surgical Arm: Proportion of study SVGs which are totally occluded on cardiac CT angiography at 1-year post-CABG and death due to CV or unknown causes. [ Time Frame: 1 year post-operative ] [ Designated as safety issue: No ]
  • Pharmacological Arm: Proportion of patients with ≥1 graft (saphenous or arterial) totally (100%) occluded on cardiac CT angiography at 1-year post-CABG and death due to CV or unknown causes, comparing the fish-oil to placebo groups. [ Time Frame: 1-year post-operative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Surgical Arm: i. To determine whether the "no touch" technique of SVG harvesting results in a lower proportion of study SVGs that have a significant stenosis (50-99%) on 1-year post-CABG angiography compared to conventional SVG harvesting techniques. [ Time Frame: 1 year post-operavtive ] [ Designated as safety issue: No ]
  • Surgical Arm: ii. To determine whether the incidence and severity of adverse SVG harvesting events at 1-yr post-CABG (infection, haematoma, swelling, neuropathy, quality of life measures) are similar between the "no touch" and conventional groups. [ Time Frame: 1-year post-operative ] [ Designated as safety issue: No ]
  • Surgical Arm: iii. To determine whether the incidence of the composite of non-fatal MI (new definition), all-cause mortality, and repeat revascularization (redo CABG or PCI) perioperatively and at 1 yr is lower in "no touch" versus conventional group. [ Time Frame: 1-year post-operative ] [ Designated as safety issue: No ]
  • Pharmacological Arm: i. To determine whether fish oil supplementation results in a lower proportion of patients with ≥1 graft with a significant (50-99%) stenosis at 1-year post-CABG angiography, compared to those who received placebo. [ Time Frame: 1-year post-operative ] [ Designated as safety issue: No ]
  • Pharmacological Arm: ii. To determine whether the incidence of the composite of non-fatal MI (new definition), all-cause mortality, and repeat revascularization (redo CABG or PCI) perioperatively and at 1 yr is lower in the fish oil versus placebo group. [ Time Frame: 1-year post-operative ] [ Designated as safety issue: No ]

Estimated Enrollment: 1550
Study Start Date: July 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: SVG harvest - conventional, placebo Procedure: No-touch SVG harvest vs conventional SVG harvest technique
Saphenous vein harvested using the pedicled (no-touch) technique or using the conventional technique. Fish oil supplements/placebo (1g taken orally twice daily for 1 year post-op)
Dietary Supplement: Fish oil supplementation vs placebo
Fish oil supplementation [1g tablets (55% fish oils - EPA:DHA 33%:22%)] taken twice daily for 1 year post-op
Other Name: Ocean Nutrition Omega Pure fish oil capsules
Experimental: SVG harvest - no-touch, fish oils Procedure: No-touch SVG harvest vs conventional SVG harvest technique
Saphenous vein harvested using the pedicled (no-touch) technique or using the conventional technique. Fish oil supplements/placebo (1g taken orally twice daily for 1 year post-op)
Dietary Supplement: Fish oil supplementation vs placebo
Fish oil supplementation [1g tablets (55% fish oils - EPA:DHA 33%:22%)] taken twice daily for 1 year post-op
Other Name: Ocean Nutrition Omega Pure fish oil capsules
Placebo Comparator: SVG harvest - no-touch, placebo Procedure: No-touch SVG harvest vs conventional SVG harvest technique
Saphenous vein harvested using the pedicled (no-touch) technique or using the conventional technique. Fish oil supplements/placebo (1g taken orally twice daily for 1 year post-op)
Dietary Supplement: Fish oil supplementation vs placebo
Fish oil supplementation [1g tablets (55% fish oils - EPA:DHA 33%:22%)] taken twice daily for 1 year post-op
Other Name: Ocean Nutrition Omega Pure fish oil capsules
Active Comparator: SVG harvest - conventional, fish oils Procedure: No-touch SVG harvest vs conventional SVG harvest technique
Saphenous vein harvested using the pedicled (no-touch) technique or using the conventional technique. Fish oil supplements/placebo (1g taken orally twice daily for 1 year post-op)
Dietary Supplement: Fish oil supplementation vs placebo
Fish oil supplementation [1g tablets (55% fish oils - EPA:DHA 33%:22%)] taken twice daily for 1 year post-op
Other Name: Ocean Nutrition Omega Pure fish oil capsules

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age > 18 years
  2. Able to provide informed consent
  3. Isolated CABG, non-emergent, on- or off-pump (cardiopulmonary bypass)
  4. Primary or re-do CABG (if re-do, all previous grafts must be occluded)
  5. Left ventricular ejection fraction >20%
  6. Require at least one SVG as part of revascularization strategy
  7. Creatinine clearance of at least 30ml/min or higher

Exclusion Criteria:

  1. Unable to use greater SV due to previous vein stripping or poor quality on mandatory preoperative Duplex study and vein mapping
  2. Contraindication to receiving follow-up 64-slice cardiac CT angiography (allergy to contrast dye, renal failure with a creatinine >180 µmol/L, uncontrolled atrial fibrillation precluding proper gating of study)
  3. Pregnant women, or women of child-bearing age
  4. Allergy to fish oil/fish products, and non-medicinal ingredients of the study product (corn oil,soybean oil,gelatin,glycerol, or carob colouring)
  5. Already taking fish oil supplements regularly (daily use in past 30 days)
  6. Congenital or acquired coagulation disorders
  7. Patients considered to be of excessive risk of wound infection according to the clinical judgement of the site surgical investigator.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01047449

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Hamilton Health Sciences Corporation
Investigators
Principal Investigator: Stephen Fremes, MD Sunnybrook Health Sciences Centre
  More Information

No publications provided

Responsible Party: Stephen E. Fremes, Head, Division of Cardiac & Vascular Surgery, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01047449     History of Changes
Other Study ID Numbers: CANNeCTIN09-11
Study First Received: January 12, 2010
Last Updated: May 8, 2014
Health Authority: Canada: Health Canada

Keywords provided by Sunnybrook Health Sciences Centre:
saphenous vein graft patency
fish oil supplementation
coronary artery bypass surgery
coronary artery disease

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014