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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

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
Change History
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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