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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02925364
Recruitment Status : Terminated (Slow recruitment)
First Posted : October 5, 2016
Last Update Posted : September 17, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Tarit Saha, Queen's University

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

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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 : September 2016
Actual Primary Completion Date : January 2020
Actual Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

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




Primary Outcome Measures :
  1. functional MRI (fMRI) [ Time Frame: 6 months postoperatively ]
    functional MRI of brain stem & spinal cord


Secondary Outcome Measures :
  1. anatomical MRI [ Time Frame: 6 months postoperatively ]
    anatomical MRI of neck & chest



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02925364


Locations
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Canada, Ontario
Kingston General Hospital
Kingston, Ontario, Canada, K7L2V7
Sponsors and Collaborators
Dr. Tarit Saha
Investigators
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Principal Investigator: Tarit Saha, MD, FRCPC Queen's University
Principal Investigator: Patrick Stroman, PhD Queen's University-Cenre for Neuroscience Studies
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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: October 5, 2016    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Tarit Saha, Queen's University:
magnetic resonance imaging
central pain processing
anatomical MRI
fMRI
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations