Long Term Follow-up of Open Versus Endoscopic Radial Artery Harvest With CT Angiography

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Bob Kiaii, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01559376
First received: February 27, 2012
Last updated: March 19, 2012
Last verified: March 2012
  Purpose

The objectives of the study are two-fold:

  1. To determine the mean 5 year patency rate of the radial artery graft (Open vs. Endoscopic) of patients who have already had CABG surgery and who previously participated in the centre's RCT back in 2005-2007 using CTA and MPS-MIBI
  2. To determine patient quality of life at 5 years post CABG surgery

It is hypothesized that the mean 5 year patency rate of the radial artery graft harvested endoscopically will be equal to or have greater patency than the radial artery graft harvested via the conventional/open technique. It is further hypothesized that patient quality of life will be similar amongst patients having had the open vs. endoscopic radial artery graft during CABG surgery.


Condition
Arteriosclerosis of Arterial Coronary Artery Bypass Graft

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Long Term Follow-up of Open Versus Endoscopic Radial Artery Harvest With CT Angiography

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Radial artery graft patency [ Time Frame: Mean 5 years ] [ Designated as safety issue: No ]
    Grade A Excellent graft with unimpaired run-off, patent graft Grade B Stenosis reducing caliber of proximal, distal anastomosis or trunk to <50% of the grafted coronary artery. This will be divided into flow limiting and non-flow limiting stenosis Grade O Occlusion


Secondary Outcome Measures:
  • Ischemia present in other coronary artery territories [ Time Frame: Mean 5 years ] [ Designated as safety issue: No ]
    Areas of decreased perfusion identified by MPS-MIBI scanning in the context of CT - angiographic results

  • Identification of left ventricular ejection fraction at rest and stress [ Time Frame: Mean 5 years ] [ Designated as safety issue: No ]
    Related in percentage of blood ejected as a fraction of left ventricular end diastolic volume

  • Quality of life post CABG via the two questionnaires; the Seattle Angina Questionnaire (SAQ) and the 36-Item Short Form Health Survey. [ Time Frame: Mean 5 years ] [ Designated as safety issue: No ]
    Numerical score based on the questionnaire scoring scales

  • Stenosis present in other coronary arteries / grafts [ Time Frame: Mean 5 year ] [ Designated as safety issue: No ]
    Based on CT - angiographic results. Grade A: unimpaired run-off, patent graft Grade B Stenosis reducing caliber of proximal, distal anastomosis or trunk to <50% of the grafted coronary artery. This will be divided into flow limiting and non-flow limiting stenosis Grade O Occlusion


Estimated Enrollment: 118
Study Start Date: February 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Endoscopic radial artery harvest
Conventional open radial artery harvest

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The patient population consists of patients that have previously participated in our RCT from 2005-2007 with an open or endoscopically harvested radial artery graft used as a bypass conduit. We are following them for 5-year follow up.

Criteria

Inclusion Criteria:

  • Patients will be included if they:

    1. Have previously participated in our RCT from 2005-2007 with an open or endoscopically harvested radial artery graft used as a bypass conduit.
    2. Willing to give informed consent to participate in the study

Exclusion Criteria:

  • Patients are excluded if they are:

    1. Expired
    2. Unable or unwilling to give informed consent
    3. History of allergic reaction to contrast material used in CTA or severe adverse reactions to medications used in MPS-MIBI procedures
    4. Kidney dysfunction
  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: NCT01559376

Locations
Canada, Ontario
London Health Sciences Centre, University Hospital
London, Ontario, Canada, N6A 5A5
London Health Sciences Centre, Victoria Hospital
London, Ontario, Canada, N6A 5W9
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Bob Kiaii, BSc, MD University of Western Ontario, Lawson Research Institute, University of Western Ontario
  More Information

No publications provided

Responsible Party: Bob Kiaii, Associate Professor and Chair, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01559376     History of Changes
Other Study ID Numbers: ENDO2012
Study First Received: February 27, 2012
Last Updated: March 19, 2012
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Arterial Occlusive Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014