Long Term Follow-up Hybrid Revascularization

November 2, 2018 updated by: Lawson Health Research Institute

Long Term Follow-up of Robotic Hybrid Surgical Revascularization With CT Angiography

OBJECTIVES:

The objectives of the year study are two-fold:

  1. To determine the 5-7 year patency rate (rate of open bypass grafts) of the LITA graft and stent of patients who have already had robotically-assisted Hybrid CABG surgery using CTA and MPS-MIBI.
  2. To determine patient quality of life at 5-7 years after robotically-assisted Hybrid CABG surgery

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

New techniques such as robotically-assisted Hybrid CABG surgery need proper evaluation to ensure potential benefits gained are not harmful to that which we know to be of significant benefit to the patients, that being the left internal thoracic artery (LITA) graft (one of the main coronary arteries supplying your heart with blood). We are therefore proposing a 5-7 year CT-Angiography (CTA) and Myocardial Perfusion Scintigraphy (MPS-MIBI) to assess the patency rate of the LITA graft and the stented graft in patients that have already undergone robotically assisted Hybrid CABG.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • London Health Sciences Centre, University & Victoria Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients that have previously had Hybrid robotic coronary artery revascularization performed approximately 5-7 years ago at the London Health Sciences Centre, University Hospital by Dr. Kiaii.

Description

Inclusion Criteria:

- Patients that have previously had Hybrid robotic coronary artery revascularization performed approximately 5-7 years ago at the London Health Sciences Centre, University Hospital by Dr. Kiaii.

Exclusion Criteria:

- Patients not described above

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hybrid robotic cabg patients
Postoperative (5-7 years)Hybrid CABG robotically assisted surgical revascularization patients
Procedure: Robotic Hybrid coronary artery revascularization
Lita to LAD performed by robot, Hybrid stent to other diseased coronary artery
Other Names:
  • Robotic Hybrid CABG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Graft patency
Time Frame: 5-7 years post Hybrid surgery
To assess the graft patency of the LITA to LAD performed by the robot and the patency of the Stent.
5-7 years post Hybrid surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Collaborators

London Health Sciences Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2013

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

September 27, 2013

First Submitted That Met QC Criteria

September 27, 2013

First Posted (Estimate)

October 7, 2013

Study Record Updates

Last Update Posted (Actual)

November 6, 2018

Last Update Submitted That Met QC Criteria

November 2, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Kiaii-LTFUP-Hybrid-2013
  • REB #15000 (Other Identifier: Lawson Health Research Institute)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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