Necrosis of Femoral HeadMRIPNDNCT03773627
MRI Maker of Perioperative Neurocognitive Disorder
An observational study of Necrosis of Femoral Head and Knee Osteoarthritis, run by RenJi Hospital at 1 site in China.
Trial summary
Periperative neurocognitive disorder(PND) is consistently associated with increased morbidity and mortality, but its mechanisms remain unclear. Moreover, valid biomarkers for the prediction or diagnosis of the development of delayed neurocognitive recovery in aged patients have not been identified so far. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Necrosis of Femoral Head, Knee Osteoarthritis, Fracture of Lower Limb
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 12 Dec 2018to 30 Jul 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients elder than 60 years old elective to undergo lower limb surgery and conform to the including criteria would be recruited.
Who may be able to join
- Age ≥ 60 years
- Spoke proficient Chinese
- Selected to lower limb osteopathic surgery
- Informed consent signed by the patient
- Underwent general anesthesia
Who cannot join
- Existing cerebral disease, or have a history of neurological and psychiatric diseases including AD, stroke, and psychosis
- Existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24
- Several audition or vision disorder
- With standard contraindications to MRI examinations
- Unwillingness to comply with the protocol or procedures.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renji Hospital
Shanghai, Shanghai Municipality, 200127
Diansan Su, +862168383702, diansansu@yahoo.com
Linke Chen
About this study
Official title: MRI Marker of Postoperative Delirium and Delayed Neurocognitive Recovery
Periperative neurocognitive disorder(PND) is consistently associated with increased morbidity and mortality, but its mechanisms remain unclear. Moreover, valid biomarkers for the prediction or diagnosis of the development of delayed neurocognitive recovery in aged patients have not been identified so far. The purpose of this study is trying to find the functional MRI marker of PND.
- Medical subject headings
- Osteoarthritis, Knee
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI markers of PND before 7th day after surgery
To analysis the association of volume of hippocampus measured by MRI and the occurrence of PND identified at the 7th day after surgery
Measured: From the day before surgery to the 7th day after surgery
Secondary outcomes (1)
MRI markers of PND before 12 month after surgery
To analysis the association of volume of hippocampus measured by MRI and the occurrence of PND identified at the 12 months after surgery
Measured: From the 7th day after surgery to 12 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2018
- Study start12 Dec 2018
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrosis of Femoral HeadStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- qi lu, Dr., Study director, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03773627
- Sponsor's protocol ID
- 2017-075
- Acronym
- MRIPND
- Status last verified
- Dec 2018
- First submitted
- 10 Dec 2018
- Last updated
- 13 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Marker of Postoperative Delirium and Delayed Neurocognitive Recovery
- ClinicalTrials.gov ID
- NCT03773627
- Acronym / sponsor ID
- MRIPND / 2017-075
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Jul 2020 (estimated)
- First posted
- 12 Dec 2018 (actual)
- 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.
Periperative neurocognitive disorder(PND) is consistently associated with increased morbidity and mortality, but its mechanisms remain unclear. Moreover, valid biomarkers for the prediction or diagnosis of the development of delayed neurocognitive recovery in aged patients have not been identified so far. The purpose of this study is trying to find the functional MRI marker of PND.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients elder than 60 years old elective to undergo lower limb surgery and conform to the including criteria would be recruited.
Key inclusion criteria (5 listed)
- Age ≥ 60 years
- Spoke proficient Chinese
- Selected to lower limb osteopathic surgery
- Informed consent signed by the patient
- Underwent general anesthesia
Key exclusion criteria (5 listed)
- Existing cerebral disease, or have a history of neurological and psychiatric diseases including AD, stroke, and psychosis
- Existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24
- Several audition or vision disorder
- With standard contraindications to MRI examinations
- Unwillingness to comply with the protocol or procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MRI markers of PND before 7th day after surgery
Time frame: From the day before surgery to the 7th day after surgery
To analysis the association of volume of hippocampus measured by MRI and the occurrence of PND identified at the 7th day after surgery
1 secondary outcome
MRI markers of PND before 12 month after surgery
Time frame: From the 7th day after surgery to 12 month after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2018.
- Individual participant dataSharing planned: Undecided
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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.
qi lu, Dr. study director
Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China
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 Necrosis of Femoral Head and Knee Osteoarthritis, run by RenJi Hospital at 1 site in China.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 13 Dec 2018. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diansan Su, Dr. (+862168383702, diansansu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI markers of PND before 7th day after surgery (time frame: From the day before surgery to the 7th day after surgery). 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 13 Dec 2018.