NCT02774824

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 17, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2017

Completed
Last Updated

January 11, 2018

Status Verified

January 1, 2018

Enrollment Period

1.9 years

First QC Date

May 5, 2016

Last Update Submit

January 9, 2018

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    from 4-6 weeks to 12 months and from 3 months to 12 months following CABG surgery

Study Arms (1)

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)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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 .

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montreal Heart Institute

Montreal, Quebec, J0N 1P0, Canada

Location

Related Publications (1)

  • 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.

    PMID: 29682294DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Louis P Perrault, MD, PhD

    Montreal Heart Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Cardiovascular Thoracic Surgeon

Study Record Dates

First Submitted

May 5, 2016

First Posted

May 17, 2016

Study Start

October 1, 2015

Primary Completion

August 24, 2017

Study Completion

August 24, 2017

Last Updated

January 11, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)