- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04210960
Correlation of Serum Lactate and Activity of Multiple Sclerosis
December 24, 2019 updated by: Ahmed Esmael, Mansoura University Hospital
Correlation of serum lactate and activity of multiple sclerosis and its correlation to different type of MS
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Correlation of serum lactate and activity of multiple sclerosis and its correlation to different type of MS and magentic resonanace imaging , magentic resonanace spectroscopy
Study Type
Observational
Enrollment (Anticipated)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Dakahlia
-
Mansoura, Dakahlia, Egypt, 35516
- Recruiting
- Mansoura University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
80 Egyptian subjects (50 multiple sclerosis patients (patients group = group I) and 30 normal healthy control (control group = group II)
Description
Inclusion Criteria:
-Patients with multiple sclerosis (RRMS,PPMS and SPMS)
Exclusion Criteria:
-Patients with any other medical conditions that may affect the serum lactate level
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients group
50 multiple sclerosis patients
|
The brain MR imaging examinations were done by using a 3 tesla scanner (Acheiva; Philips Medical Systems, Best, Netherlands).
All patients were examined in the supine position using head coil.
Routine images (T2, T1, FLAIR) and double inversion recovery sequence (DIR) were done to all patients: repetition time (TR) _ 9583 sec, echo time (TE) _ 25 sec, inversion time (TI) _ 3400 sec, IR delay _ 325 sec, echo train length (ETL) _ 17, 50 contiguous axial slices, thickness _ 3 mm, matrix size 240× 142 mm2, field of view (FOV) 230× 184 mm2.
Magnetic Resonance (MR) spectroscopy is a noninvasive diagnostic test for measuring biochemical changes in the brain.While magnetic resonance imaging (MRI) identifies the anatomical location of a lesion, MR spectroscopy compares the chemical composition of normal brain tissue with abnormal brain tissue.
This test can also be used to detect tissue changes in stroke and epilepsy.
|
Control group
30 normal healthy control
|
The brain MR imaging examinations were done by using a 3 tesla scanner (Acheiva; Philips Medical Systems, Best, Netherlands).
All patients were examined in the supine position using head coil.
Routine images (T2, T1, FLAIR) and double inversion recovery sequence (DIR) were done to all patients: repetition time (TR) _ 9583 sec, echo time (TE) _ 25 sec, inversion time (TI) _ 3400 sec, IR delay _ 325 sec, echo train length (ETL) _ 17, 50 contiguous axial slices, thickness _ 3 mm, matrix size 240× 142 mm2, field of view (FOV) 230× 184 mm2.
Magnetic Resonance (MR) spectroscopy is a noninvasive diagnostic test for measuring biochemical changes in the brain.While magnetic resonance imaging (MRI) identifies the anatomical location of a lesion, MR spectroscopy compares the chemical composition of normal brain tissue with abnormal brain tissue.
This test can also be used to detect tissue changes in stroke and epilepsy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biochemical testing
Time Frame: 2 days
|
Plasma lactate was assayed according to Trinder method14 .
All assays were carried out with Bechman Coulter AU480 autoanalyzer (USA).
|
2 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 23, 2019
Primary Completion (ANTICIPATED)
May 1, 2020
Study Completion (ANTICIPATED)
June 1, 2020
Study Registration Dates
First Submitted
December 22, 2019
First Submitted That Met QC Criteria
December 22, 2019
First Posted (ACTUAL)
December 26, 2019
Study Record Updates
Last Update Posted (ACTUAL)
December 27, 2019
Last Update Submitted That Met QC Criteria
December 24, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Mansoura University H 10
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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