Clinical Trials Directory

Trials / Terminated

TerminatedNCT02925364

Functional and Anatomical MRI of the Spinal Cord and Peri-spinal Tissues

Functional and Anatomical MRI of the Spinal Cord and Perispinal Tissues 6 Months After Cardiac Surgery With Standard vs. Gradual Sternal Retraction: Implications for Chronic Post-surgical Pain

Status
Terminated
Phase
Study type
Observational
Enrollment
17 (actual)
Sponsor
Dr. Tarit Saha · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

Summary

The current study is an amendment to a previously approved blinded randomized controlled trial (NCT02697812) which examines the rate at which the sternal retraction maneuver is performed during cardiac surgery (standard over 30 seconds versus. gradual over 15 minutes) and examines the incidence of chronic post-sternotomy pain 6 months following surgery. Patients enrolled in the parent study will be identified at the 6 month follow-up and recruited in terms of whether they report chest pain. A total of 30 participants will be recruited (15 with and 15 with no pain) to undergo a single MRI session in which functional MRI will be done on the brain stem and spinal cord and anatomical MRI images will be collected for specific chest and neck structures. This will indicate whether there are long-term differences in pain processing and/or physical damage to neck and chest structures in those with and without chronic pain 6 months following coronary artery bypass graft surgery. All functional and anatomical MRI images will be reviewed and interpreted with study personnel blinded to whether the patient is reporting pain or no pain at their 6 month follow-up interview.

Conditions

Interventions

TypeNameDescription
RADIATIONmagnetic resonance imaging (MRI)all participants will undergo a functional MRI and an anatomical MRI in a single session

Timeline

Start date
2016-09-01
Primary completion
2020-01-01
Completion
2020-01-01
First posted
2016-10-05
Last updated
2023-06-22

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT02925364. Inclusion in this directory is not an endorsement.