NCT04210960

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

December 23, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 26, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

December 27, 2019

Status Verified

December 1, 2019

Enrollment Period

4 months

First QC Date

December 22, 2019

Last Update Submit

December 24, 2019

Conditions

Keywords

Multiple sclerosis, serum lactate and MRS

Outcome Measures

Primary Outcomes (1)

  • Biochemical testing

    Plasma lactate was assayed according to Trinder method14 . All assays were carried out with Bechman Coulter AU480 autoanalyzer (USA).

    2 days

Study Arms (2)

Patients group

50 multiple sclerosis patients

Radiation: Magentic resonanace imagingRadiation: Magentic resonanace spectroscopy

Control group

30 normal healthy control

Radiation: Magentic resonanace imagingRadiation: Magentic resonanace spectroscopy

Interventions

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.

Control groupPatients group

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 groupPatients group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

80 Egyptian subjects (50 multiple sclerosis patients (patients group = group I) and 30 normal healthy control (control group = group II)

You may qualify if:

  • Patients with multiple sclerosis (RRMS,PPMS and SPMS)

You may not qualify if:

  • Patients with any other medical conditions that may affect the serum lactate level

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, 35516, Egypt

RECRUITING

Related Publications (1)

  • Esmael A, Talaat M, Egila H, Eltoukhy K. Mitochondrial dysfunction and serum lactate as a biomarker for the progression and disability in MS and its correlation with the radiological findings. Neurol Res. 2021 Jul;43(7):582-590. doi: 10.1080/01616412.2021.1893567. Epub 2021 Mar 4.

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Esmael M Ahmed, MD

    Assistant Prof of Neurology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Esmael M Ahmed, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Prof of Neurology

Study Record Dates

First Submitted

December 22, 2019

First Posted

December 26, 2019

Study Start

December 23, 2019

Primary Completion

May 1, 2020

Study Completion

June 1, 2020

Last Updated

December 27, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations