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

NCT01559376 | Completed

• 1 other identifier: ENDO2012
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 2

Brief Summary

The objectives of the study are two-fold:

1. 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. 2.To determine patient quality of life at 5 years post CABG surgery

Conditions

Arteriosclerosis of Arterial Coronary Artery Bypass Graft

Outcome Measures

Primary Outcomes (1)

• Radial artery graft patency

  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

  Mean 5 years

Secondary Outcomes (4)

• Ischemia present in other coronary artery territories

  Mean 5 years

• Identification of left ventricular ejection fraction at rest and stress

  Mean 5 years

• Quality of life post CABG via the two questionnaires; the Seattle Angina Questionnaire (SAQ) and the 36-Item Short Form Health Survey.

  Mean 5 years

• Stenosis present in other coronary arteries / grafts

  Mean 5 year

Study Arms (2)

Endoscopic radial artery harvest

Conventional open radial artery harvest

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients will be included if they:
• Have previously participated in our RCT from 2005-2007 with an open or endoscopically harvested radial artery graft used as a bypass conduit.
• Willing to give informed consent to participate in the study

You may not qualify if:

• Patients are excluded if they are:
• Expired
• Unable or unwilling to give informed consent
• History of allergic reaction to contrast material used in CTA or severe adverse reactions to medications used in MPS-MIBI procedures
• Kidney dysfunction

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (2)

London Health Sciences Centre, University Hospital

London, Ontario, N6A 5A5, Canada

Location

London Health Sciences Centre, Victoria Hospital

London, Ontario, N6A 5W9, Canada

Location

Study Officials

• Bob Kiaii, BSc, MD

  University of Western Ontario, Lawson Research Institute, University of Western Ontario

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2012
• First Posted: March 21, 2012
• Study Start: February 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2015
• Last Updated: August 28, 2017

Record last verified: 2012-03

Locations

CA (2)