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

• ClinicalTrials.gov Identifier: NCT02925364
• Recruitment Status: Terminated
• First Posted: October 5, 2016
• Last Update Posted: September 17, 2020
• Sponsor: Dr. Tarit Saha
• Information provided by (Responsible Party): Dr. Tarit Saha, Queen's University

Tracking Information

• First Submitted Date: October 4, 2016
• First Posted Date: October 5, 2016
• Last Update Posted Date: September 17, 2020
• Actual Study Start Date: September 2016
• Actual Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 4, 2016)

functional MRI (fMRI) [ Time Frame: 6 months postoperatively ]

functional MRI of brain stem & spinal cord

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 4, 2016)

anatomical MRI [ Time Frame: 6 months postoperatively ]

anatomical MRI of neck & chest

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Functional and Anatomical MRI of the Spinal Cord and Peri-spinal Tissues
• Official Title: 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

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 Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Cross-Sectional
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.

Condition

• Chronic Pain
• Other Functional Disturbances Following Cardiac Surgery

Intervention

Radiation: magnetic resonance imaging (MRI)

all participants will undergo a functional MRI and an anatomical MRI in a single session

Study Groups/Cohorts

• 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
  Intervention: Radiation: magnetic resonance imaging (MRI)
• 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
  Intervention: Radiation: magnetic resonance imaging (MRI)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: October 4, 2016): 30
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: January 2020
• Actual Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT02925364
• Other Study ID Numbers: ANAE-233-13-amendment
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Dr. Tarit Saha, Queen's University
• Study Sponsor: Dr. Tarit Saha
• Collaborators: Not Provided

Investigators

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

• PRS Account: Queen's University
• Verification Date: September 2020