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

• Sponsor: Dr. Tarit Saha (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02925364
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Actual Duration (Months): 40
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain; Other Functional Disturbances Following Cardiac Surgery	Radiation: magnetic resonance imaging (MRI)

Study Design

• Study Type: Observational
• Actual Enrollment: 30 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• 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
• Actual Study Start Date: Sep 1, 2016
• Actual Primary Completion Date: Jan 1, 2020
• Actual Study Completion Date: Jan 1, 2020

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. functional MRI (fMRI) [6 months postoperatively]

   functional MRI of brain stem & spinal cord

Secondary Outcome Measures

1. anatomical MRI [6 months postoperatively]

   anatomical MRI of neck & chest

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kingston General Hospital	Kingston	Ontario	Canada	K7L2V7

Sponsors and Collaborators

• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Tarit Saha, Director, cardiac anesthesia group, Queen's University
• ClinicalTrials.gov Identifier: NCT02925364
• Other Study ID Numbers: ANAE-233-13-amendment
• First Posted: Oct 5, 2016
• Last Update Posted: Sep 17, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Dr. Tarit Saha, Director, cardiac anesthesia group, Queen's University: magnetic resonance imaging; central pain processing; anatomical MRI; fMRI
• Additional relevant MeSH terms: Chronic Pain

Study Results

No Results Posted as of Sep 17, 2020