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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

17 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2020-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Pain Other Functional Disturbances Following Cardiac Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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

magnetic resonance imaging (MRI)

Intervention Type RADIATION

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

magnetic resonance imaging (MRI)

Intervention Type RADIATION

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

Interventions

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magnetic resonance imaging (MRI)

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

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No