Coronary Artery DiseaseNCT02774824
9 Months Extension Study of SOMVC001 Study (GALA) Vascular Conduit Preservation Solution
An observational study of Coronary Artery Disease, run by Perrault Louis P. at 1 site in Canada.
Trial 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)". Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 53 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2015to 24 Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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 .
Who may be able to join
- patients from protocol #003-03 who agree to be followed for an additional 9 months by signing informed consent.
Who cannot join
- patients who have a contraindication to undergo MDCT angiography ant 12 months post CABG surgery.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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).
Read the 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.
- Conditions
- Coronary Artery Disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: At twelve months following CABG surgery
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: from 4-6 weeks to 12 months and from 3 months to 12 months following CABG surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study start1 Oct 2015
- Primary completion24 Aug 2017
- Study completion24 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Perrault Louis P.
- Sponsor type
- University, hospital or other
- Collaborators
- Montreal Heart Institute, Somahlution LLC
- Responsible party
- Sponsor-investigator, Perrault Louis P., Montreal Heart Institute
- Investigators
- Louis P Perrault, MD, PhD, Principal investigator, Montreal Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02774824
- Sponsor's protocol ID
- 003-10
- Status last verified
- Jan 2018
- First submitted
- 5 May 2016
- Last updated
- 11 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ben Ali W, Voisine P, Olsen PS, Jeanmart H, Noiseux N, Goeken T, Satishchandran V, Cademartiri F, Cutter G, Veerasingam D, Brown C, Emmert MY, Perrault LP. DuraGraft vascular conduit preservation solution in patients undergoing coronary artery bypass grafting: rationale and design of a within-patient randomised multicentre trial. Open Heart. 2018 Apr 13;5(1):e000780. doi: 10.1136/openhrt-2018-000780. eCollection 2018.
PubMed 29682294
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02774824
- Acronym / sponsor ID
- 003-10
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Perrault Louis P.University, hospital or other
- Collaborators
- Montreal Heart Institute, Somahlution LLC
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 24 Aug 2017 (actual)
- Study completion
- 24 Aug 2017 (actual)
- First posted
- 17 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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 .
Key inclusion criteria (1 listed)
- patients from protocol #003-03 who agree to be followed for an additional 9 months by signing informed consent.
Key exclusion criteria (1 listed)
- patients who have a contraindication to undergo MDCT angiography ant 12 months post CABG surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
4 secondary outcomes
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
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.
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2018.
- Derived from this study: PubMed 29682294Ben Ali W, Voisine P, Olsen PS, Jeanmart H, Noiseux N, Goeken T, Satishchandran V, Cademartiri F, Cutter G, Veerasingam D, Brown C, Emmert MY, Perrault LP. DuraGraft vascular conduit preservation solution in patients undergoing coronary artery bypass grafting: rationale and design of a within-patient randomised multicentre trial. Open Heart. 2018 Apr 13;5(1):e000780. doi: 10.1136/openhrt-2018-000780. eCollection 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louis P Perrault, MD, PhD principal investigator
Montreal Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Perrault Louis P. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02774824, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2018; AzTrials last refreshed its copy on 7 Nov 2026.