An observational study in Coronary Artery Disease, sponsored by Perrault Louis P.. Completed at 1 site in Canada. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-01-11.
Sponsored by Perrault Louis P. · Observational
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).
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 53 is below the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Perrault Louis P. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who had a coronary artery bypass graft surgery (CABG), and took part in previous main study of SOMVC001 (GALA) protocol ID # 003-03 .
Exclusion Criteria:
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)
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) .
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.
Time frame: 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).
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.
Time frame: At twelve months following CABG surgery
The incidence of vein graft thrombosis will be measured as total graft occlusion
Using a 64-slice or better multi-detector computed tomography (MDCT) angiography.
Time frame: At twelve months following CABG surgery
The change in maximal stenosis will be measured and expressed in millimeter (mm) as changes over time.
Using a 64-slice or better multi-detector computed tomography (MDCT) angiography.
Time frame: 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.
Using a 64-slice or better multi-detector computed tomography (MDCT) angiography.
Time frame: 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.
Using a 64-slice or better multi-detector computed tomography (MDCT) angiography.
Time frame: 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.
Using a 64-slice or better multi-detector computed tomography (MDCT) angiography.
Time frame: from 4-6 weeks to 12 months and from 3 months to 12 months following CABG surgery
Plan to share: No
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Perrault Louis P.