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

NCT02925364 | Terminated

• 1 other identifier: ANAE-233-13-amendment
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Other Functional Disturbances Following Cardiac Surgery

Keywords

magnetic resonance imaging; central pain processing; anatomical MRI; fMRI

Outcome Measures

Primary Outcomes (1)

• functional MRI (fMRI)

  functional MRI of brain stem \& spinal cord

  6 months postoperatively

Secondary Outcomes (1)

• anatomical MRI

  6 months postoperatively

Study Arms (2)

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)

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)

Interventions

magnetic resonance imaging (MRI) RADIATION

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

No pain; Pain

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Elective Primary Coronary Artery Bypass Surgery
• Understanding and provision of written informed consent
• Age \> 18 and \< 75
• ASA class I, II or II

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Tarit Saha: lead

Study Sites (1)

Kingston General Hospital

Kingston, Ontario, K7L2V7, Canada

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Tarit Saha, MD, FRCPC

  Queen's University

  PRINCIPAL INVESTIGATOR

• Patrick Stroman, PhD

  Queen's University-Cenre for Neuroscience Studies

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, cardiac anesthesia group

Study Record Dates

• First Submitted: October 4, 2016
• First Posted: October 5, 2016
• Study Start: September 1, 2016
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)