Chronic PainNCT02925364
Functional and Anatomical MRI of the Spinal Cord and Peri-spinal Tissues
An observational study of Chronic Pain and Other Functional Disturbances Following Cardiac Surgery, run by Dr. Tarit Saha at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Pain, Other Functional Disturbances Following Cardiac Surgery
- What is being tested?
- magnetic resonance imaging (MRI)
- Type of treatment
- Surgery or procedure
- How many people
- 17 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2016to Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Elective Primary Coronary Artery Bypass Surgery
- Understanding and provision of written informed consent
- Age > 18 and < 75
- ASA class I, II or II
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- magnetic resonance imaging (MRI)
- Keywords
- magnetic resonance imaging, central pain processing, anatomical MRI, fMRI
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic resonance imaging (MRI)Radiation
all participants will undergo a functional MRI and an anatomical MRI in a single session
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Radiation: magnetic resonance imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional MRI (fMRI)
functional MRI of brain stem \& spinal cord
Measured: 6 months postoperatively
Secondary outcomes (1)
anatomical MRI
anatomical MRI of neck \& chest
Measured: 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionJan 2020
- Study completionJan 2020
Why it stopped: Slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Tarit Saha
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Tarit Saha, Queen's University
- Investigators
- Tarit Saha, MD, FRCPC, Principal investigator, Queen's UniversityPatrick Stroman, PhD, Principal investigator, Queen's University-Cenre for Neuroscience Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02925364
- Sponsor's protocol ID
- ANAE-233-13-amendment
- Status last verified
- Jun 2023
- First submitted
- 4 Oct 2016
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02925364
- Acronym / sponsor ID
- ANAE-233-13-amendment
- Keywords
- magnetic resonance imaging, central pain processing, anatomical MRI, fMRI
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Dr. Tarit SahaUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 5 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No pain | – | Radiation: magnetic resonance imaging (MRI)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 |
| Pain | – | Radiation: magnetic resonance imaging (MRI)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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Elective Primary Coronary Artery Bypass Surgery
- Understanding and provision of written informed consent
- Age > 18 and < 75
- ASA class I, II or II
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| magnetic resonance imaging (MRI)all participants will undergo a functional MRI and an anatomical MRI in a single session | Radiation | No pain, Pain |
Primary outcome
functional MRI (fMRI)
Time frame: 6 months postoperatively
functional MRI of brain stem \& spinal cord
1 secondary outcome
anatomical MRI
Time frame: 6 months postoperatively
Results and safety
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tarit Saha, MD, FRCPC principal investigator
Queen's University
Patrick Stroman, PhD principal investigator
Queen's University-Cenre for Neuroscience Studies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and Other Functional Disturbances Following Cardiac Surgery, run by Dr. Tarit Saha at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional MRI (fMRI) (time frame: 6 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.