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

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ClinicalTrials.gov Identifier: NCT02774824
Recruitment Status : Completed
First Posted : May 17, 2016
Last Update Posted : January 11, 2018
Sponsor:
Collaborators:
Montreal Heart Institute
Somahlution LLC
Information provided by (Responsible Party):
Perrault Louis P., Montreal Heart Institute

Brief Summary:
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).

Condition or disease
Coronary Artery Disease

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
Actual Enrollment : 53 participants
Observational Model: Other
Time Perspective: Other
Official Title: 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)
Actual Study Start Date : October 1, 2015
Actual Primary Completion Date : August 24, 2017
Actual Study Completion Date : August 24, 2017

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 .
Criteria

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.

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): NCT02774824


Locations
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, J0N 1P0
Sponsors and Collaborators
Perrault Louis P.
Montreal Heart Institute
Somahlution LLC
Investigators
Principal Investigator: Louis P Perrault, MD, PhD Montreal Heart Institute

Responsible Party: Perrault Louis P., Cardiovascular Thoracic Surgeon, Montreal Heart Institute
ClinicalTrials.gov Identifier: NCT02774824     History of Changes
Other Study ID Numbers: 003-10
First Posted: May 17, 2016    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases