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

Terminated

• Conditions: Other Functional Disturbances Following Cardiac Surgery; Chronic Pain
• Interventions: Radiation: magnetic resonance imaging (MRI)

• Registration Number: NCT02925364
• Lead Sponsor: Dr. Tarit Saha

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-10-04
• Study First Submitted QC: 2016-10-04
• Study First Posted: 2016-10-05
• Primary Completion: 2020-01
• Study Completion: 2020-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-20
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No pain	magnetic resonance imaging (MRI)	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
Pain	magnetic resonance imaging (MRI)	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

Primary Outcome Measures

Name	Time	Method
functional MRI (fMRI)	6 months postoperatively	functional MRI of brain stem \& spinal cord

Secondary Outcome Measures

Name	Time	Method
anatomical MRI	6 months postoperatively	anatomical MRI of neck \& chest

Trial Locations

Locations (1)

Kingston General Hospital; 🇨🇦 Kingston, Ontario, Canada