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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01559376
First Posted: March 21, 2012
Last Update Posted: August 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Lawson Health Research Institute
  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 ]
    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 ]
    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 ]
    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 ]
    Numerical score based on the questionnaire scoring scales

  • Stenosis present in other coronary arteries / grafts [ Time Frame: Mean 5 year ]
    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
Study Completion Date: February 2015
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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01559376     History of Changes
Other Study ID Numbers: ENDO2012
First Submitted: February 27, 2012
First Posted: March 21, 2012
Last Update Posted: August 28, 2017
Last Verified: March 2012

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