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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Chronic Pain, Other Functional Disturbances Following Cardiac Surgery

Intervention / Treatment
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* Radiation: magnetic resonance imaging (MRI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective Primary Coronary Artery Bypass Surgery Understanding and provision of written informed consent Age > 18 and < 75 ASA class I, II or II Exclusion Criteria: Any combined or redo cardiac procedure Current alcohol or substance abuse Pre-existing chronic pain requiring chronic analgesic use Rest pain in proposed surgical area at baseline, preoperatively Chronic Steroid use Inability to perform post-operative assessments

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No pain<br>patients who are enrolled in the parent study and report no chest pain at their 6 month post-cardiac surgery follow-up will undergo functional and anatomical MRI | Radiation: magnetic resonance imaging (MRI)<br>* all participants will undergo a functional MRI and an anatomical MRI in a single session<br>|
| Pain<br>Patients who are enrolled in the parent study and report chest pain at their 6 month post-cardiac surgery follow-up will undergo functional and anatomical MRI | Radiation: magnetic resonance imaging (MRI)<br>* all participants will undergo a functional MRI and an anatomical MRI in a single session<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functional MRI (fMRI) | functional MRI of brain stem & spinal cord | 6 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anatomical MRI | anatomical MRI of neck & chest | 6 months postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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magnetic resonance imaging, central pain processing, anatomical MRI, fMRI