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Correlation of Serum Lactate and Activity of Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT04210960
Recruitment Status : Recruiting
First Posted : December 26, 2019
Last Update Posted : December 27, 2019
Sponsor:
Information provided by (Responsible Party):
Ahmed Esmael, Mansoura University Hospital

Brief Summary:
Correlation of serum lactate and activity of multiple sclerosis and its correlation to different type of MS

Condition or disease Intervention/treatment
Multiple Sclerosis Radiation: Magentic resonanace imaging Radiation: Magentic resonanace spectroscopy

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

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Correlation of Serum Lactate and Activity of Multiple Sclerosis
Actual Study Start Date : December 23, 2019
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients group
50 multiple sclerosis patients
Radiation: Magentic resonanace imaging
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.

Radiation: Magentic resonanace spectroscopy
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
Radiation: Magentic resonanace imaging
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.

Radiation: Magentic resonanace spectroscopy
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.




Primary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04210960


Contacts
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Contact: Esmael M Ahmed, MD 00201000372787 deltaneuro@yahoo.com

Locations
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Egypt
Mansoura University Hospital Recruiting
Mansoura, Dakahlia, Egypt, 35516
Contact: Esmael M Ahmed, MD    00201000382898    deltaneuro@yahoo.com   
Sponsors and Collaborators
Mansoura University Hospital
Investigators
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Principal Investigator: Esmael M Ahmed, MD Assistant Prof of Neurology

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Responsible Party: Ahmed Esmael, Assistant Prof of Neurology, Mansoura University Hospital
ClinicalTrials.gov Identifier: NCT04210960    
Other Study ID Numbers: Mansoura University H 10
First Posted: December 26, 2019    Key Record Dates
Last Update Posted: December 27, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ahmed Esmael, Mansoura University Hospital:
Multiple sclerosis, serum lactate and MRS
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases