9 Months Extension Study of SOMVC001 Study (GALA) Vascular Conduit Preservation Solution

January 9, 2018 updated by: Perrault Louis P.

A 9-month Extension Study to: A Study to Evaluate the Use of SOMVC001 (GALA) Vascular Conduit Preservation Solution in Patients Undergoing Coronary Artery Bypass Grafting (CABG)

This is a 9-months extension to the following study, protocol number: 003-03: "A study to evaluate the use of SOMVC001 (GALA) vascular conduit preservation solution in patients undergoing coronary artery bypass grafting (GABG)". Participation is allowed exclusively to participants enrolled in the main protocol SOMVC001 (GALA).

Study Overview

Status

Completed

Conditions

Detailed Description

Patients enrolled in this 9-months extension study of SOMVC001 (GALA) will be contacted by phone twice: 6 months and 9 months after a coronary artery bypass graft (CABG) surgery. During these phone call visits and at twelve months post CABG surgery, adverse events and/or concomitant medication changes will be collected from the participant. Twelve months after the CABG surgery procedure, imaging will be performed using 64-slice or better MDCT-scan angiography. The study participation ends at this MDCT-scan visit.

In detail, will be recorded incidence of composite safety outcomes consisting of Major Adverse Cardiac Events (MACE) (death, myocardial infarction [MI], and repeat revascularization), angina, arrhythmias, shortness of breath [SOB], decreased lumen change, graft occlusion and significant stenosis based on Fitzgibbon's scale B and O, following CABG surgery.

Patients in this study are their own control; they receive two SVG; one exposed to GALA and the other exposed to heparinized dose saline. The effect of treatment (GALA vs. Saline) will be evaluated on paired grafts within-person. Therefore, treatment effect will be presented by graft and not by patient. Only adverse clinical events will be presented by patient including their potential relationship to the study product.

Study Type

Observational

Enrollment (Actual)

53

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
    • Quebec
      • Montreal, Quebec, Canada, J0N 1P0
        • Montreal Heart Institute

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who had a coronary artery bypass graft surgery (CABG), and took part in previous main study of SOMVC001 (GALA) protocol ID # 003-03 .

Description

Inclusion Criteria:

  • patients from protocol #003-03 who agree to be followed for an additional 9 months by signing informed consent.

Exclusion Criteria:

  • patients who have a contraindication to undergo MDCT angiography ant 12 months post CABG surgery.

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
CABG patients from protocol 003-03

Patients who will agree to be followed for an additional 9 months, which include:

2 phone calls at 6 and 9 months after coronary artery bypass graft surgery

1 clinic visit at 12 months after coronary artery bypass graft surgery ( 64-slice or better MDCT angiography)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
It will be measured and reported, the mean lumen diameter of paired grafts (one treated vs one not treated) within-person. Mean lumen diameter will be expressed in millimeter (mm) .
Time Frame: At twelve months following CABG surgery
performing a 64-slice or better multi-detector computed tomography (MDCT) angiography, by assessing the magnitude of change in the mean lumen diameter of paired grafts within person, one year post- surgery.
At twelve months following CABG surgery
It will be measured and reported, the maximum stenosis of paired grafts (one treated vs one not treated) within-person. The maximum stenosis will be expressed in millimeter (mm).
Time Frame: At twelve months following CABG surgery
Performing a 64-slice or better multi-detector computed tomography (MDCT) angiography by assessing the magnitude of change at maximum stenosis of paired grafts within person, one year post-surgery.
At twelve months following CABG surgery
The incidence of vein graft thrombosis will be measured as total graft occlusion
Time Frame: At twelve months following CABG surgery
Using a 64-slice or better multi-detector computed tomography (MDCT) angiography.
At twelve months following CABG surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change in maximal stenosis will be measured and expressed in millimeter (mm) as changes over time.
Time Frame: from 4-6 weeks to 12 months and from 3 months to 12 months following CABG surgery
Using a 64-slice or better multi-detector computed tomography (MDCT) angiography.
from 4-6 weeks to 12 months and from 3 months to 12 months following CABG surgery
The change in lumen will be measured and expressed in millimeter (mm) as changes over time.
Time Frame: from 4-6 weeks to 12 months and from 3 months to 12 months following CABG surgery.
Using a 64-slice or better multi-detector computed tomography (MDCT) angiography.
from 4-6 weeks to 12 months and from 3 months to 12 months following CABG surgery.
The change in vessel diameter will be measured and expressed in millimeter (mm) as changes over time.
Time Frame: from 4-6 weeks to 12 months and from 3 months to 12 months following CABG surgery
Using a 64-slice or better multi-detector computed tomography (MDCT) angiography.
from 4-6 weeks to 12 months and from 3 months to 12 months following CABG surgery
The change in total wall thickness will be measured and expressed in millimeter (mm) as changes over time.
Time Frame: from 4-6 weeks to 12 months and from 3 months to 12 months following CABG surgery
Using a 64-slice or better multi-detector computed tomography (MDCT) angiography.
from 4-6 weeks to 12 months and from 3 months to 12 months following CABG surgery

Collaborators and Investigators

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

Sponsor

Perrault Louis P.

Collaborators

Montreal Heart Institute
Somahlution LLC

Investigators

  • Principal Investigator: Louis P Perrault, MD, PhD, Montreal Heart Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 1, 2015

Primary Completion (Actual)

August 24, 2017

Study Completion (Actual)

August 24, 2017

Study Registration Dates

First Submitted

May 5, 2016

First Submitted That Met QC Criteria

May 12, 2016

First Posted (Estimate)

May 17, 2016

Study Record Updates

Last Update Posted (Actual)

January 11, 2018

Last Update Submitted That Met QC Criteria

January 9, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 003-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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