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

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Pain; Other Functional Disturbances Following Cardiac Surgery
• Intervention / Treatment: Radiation: magnetic resonance imaging (MRI)

• Study Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L2V7
      • Kingston General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will be those enrolled in a parent blinded randomized controlled trial (NCT02697812). At their 6 month post-cardiac surgery interview, patients reporting no chest pain (n=15) or chest pain (n=15) will be recruited to undergo an MRI.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
No pain; 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); all participants will undergo a functional MRI and an anatomical MRI in a single session
Pain; 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); all participants will undergo a functional MRI and an anatomical MRI in a single session

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dr. Tarit Saha
• Investigators: Principal Investigator: Tarit Saha, MD, FRCPC, Queen's University; Principal Investigator: Patrick Stroman, PhD, Queen's University-Cenre for Neuroscience Studies

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: October 4, 2016
• First Submitted That Met QC Criteria: October 4, 2016
• First Posted (Estimated): October 5, 2016

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 20, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: magnetic resonance imaging; fMRI; central pain processing; anatomical MRI
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: ANAE-233-13-amendment

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No