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MMP-3 and 9 in RA and Their Relation to Cardiovascular Affection , Disease Activity and Treatment Response

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ClinicalTrials.gov Identifier: NCT03194204
Recruitment Status : Not yet recruiting
First Posted : June 21, 2017
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
Eman Mohammed Ibrahem Kamel, Assiut University

Brief Summary:
Rheumatoid Arthritis (RA) is a chronic inflammatory disease characterized by joint swelling, joint tenderness and destruction of synovial joints, leading to severe disability and premature mortality.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Diagnostic Test: matrix metalloproteinase -3(MMP-3) and Matrix metalloproteinase-9 (MMP-9)

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Matrix Metalloproteinase- 3 and 9 in Rheumatoid Arthritis and Their Relation to Cardiovascular Affection , Disease Activity and Treatment Response
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
rheumatoid arthritis patients

matrix metalloproteinase-3(MMP-3) and matrix metalloproteinase-9(MMP-9), Erythrocyte sedimentation rate C- reactive protein Complete blood count Urine analysis Renal and liver function tests Lipid profile, blood glucose level Serum uric acid Rheumatoid factor (RF IgM, U/L) Anti- cyclic citrullinated peptide . Radiological assessment :Plain radiographs of both hands and feet in the postero-anterior views .

Cardiac assessment :By electrocardiogram ( ECG ) and echocardiography , Carotid artery intima-medial thickness (IMT) will be done by colored doppler ultrasound.

Diagnostic Test: matrix metalloproteinase -3(MMP-3) and Matrix metalloproteinase-9 (MMP-9)
MMP-3 and MMP-9 will be done with blood samples using ELISA technique CIMT will be done using colored doppler ultrasound
Other Names:
  • Erythrocyte sedimentation rate (ESR)
  • Complete blood count (CBC).
  • Lipid profile
  • Renal and liver function tests
  • Serum uric acid
  • Rheumatoid factor (RF IgM, U/L)
  • Anti- cyclic citrullinated peptide
  • plain radiographs of both hands and feet
  • electrocardiogram ( ECG ) and echocardiography
  • Carotid artery intima-medial thickness (CIMT)
  • C-reactive protein (CRP)
  • blood glucose level

healthy controls

Matrix Metalloproteinase-3 (MMP-3) and Matrix Metalloproteinase-9 (MMP-9) Erythrocyte sedimentation rate C- reactive protein Complete blood count Urine analysis Renal and liver function tests Lipid profile, blood glucose level Serum uric acid , Rheumatoid factor (RF IgM(immunoglobulin M), U/L) Anti- cyclic citrullinated peptide. Radiological assessment :Plain radiographs of both hands and feet in the postero-anterior views.

Cardiac assessment :

By electrocardiogram ( ECG ) and echocardiography Carotid artery intima-medial thickness (IMT) will be done by colored doppler ultrasound.

Diagnostic Test: matrix metalloproteinase -3(MMP-3) and Matrix metalloproteinase-9 (MMP-9)
MMP-3 and MMP-9 will be done with blood samples using ELISA technique CIMT will be done using colored doppler ultrasound
Other Names:
  • Erythrocyte sedimentation rate (ESR)
  • Complete blood count (CBC).
  • Lipid profile
  • Renal and liver function tests
  • Serum uric acid
  • Rheumatoid factor (RF IgM, U/L)
  • Anti- cyclic citrullinated peptide
  • plain radiographs of both hands and feet
  • electrocardiogram ( ECG ) and echocardiography
  • Carotid artery intima-medial thickness (CIMT)
  • C-reactive protein (CRP)
  • blood glucose level




Primary Outcome Measures :
  1. Change in the blood levels of MMP-3 within two months of therapy [ Time Frame: at day one of the study and 2 months later after therapy ]
    Blood samples using ELISA technique

  2. Change in the blood levels of MMP-9 within two months of therapy [ Time Frame: at day one of the study and 2 months later after therapy ]
    Blood samples using ELISA technique


Secondary Outcome Measures :
  1. ESR [ Time Frame: 1 day ]
    blood samples

  2. CRP [ Time Frame: 1 day ]
    blood samples

  3. RF [ Time Frame: 1 day ]
    blood sample , IgM(immunoglobulin M)

  4. CIMT [ Time Frame: 1 day ]
    colored doppler ultrasound


Biospecimen Retention:   Samples Without DNA
blood and serum samples separated br centrifugation


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

This study will include 80 patients with RA as defined by the 2010 ACR/EULAR classification criteria , attending the outpatient clinic of the Rheumatology Unit in Internal medicine department, Assuit University Hospital together with 40 healthy controls of the same age group.

Patient groups:

  • Group 1 40 newly diagnosed RA patients.
  • Group 2 40 old RA patients.
Criteria

Inclusion Criteria:

  • Patients included in this study are patients with RA (either newly or previously diagnosed) with their age between 30-50 years old having the same normal range of body mass index

Exclusion Criteria:

  1. - The investigators will exclude patients with risk factors for atherosclerosis other than rheumatoid arthritis such as:

    • Smoking.
    • Obesity.
    • Hypertension.
    • Diabetes.
    • History of renal or liver diseases.
    • Corticosteroid therapy. 2- Intercurrent infections as they may interfere with levels of metalloproteinases.

      3- Pregnant or lactating females .


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): NCT03194204


Contacts
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Contact: Salwa S. Elgendi, MD 01005766155 salwaelgendi@yahoo.com
Contact: Hanan S. Mohammed, MD 01005035006 dr_hanansharaf@yahoo.com

Locations
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Egypt
Assiut University Not yet recruiting
Assiut, Egypt, 71000515
Sponsors and Collaborators
Assiut University

Publications of Results:

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Responsible Party: Eman Mohammed Ibrahem Kamel, principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03194204     History of Changes
Other Study ID Numbers: 17200080
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: July 3, 2018
Last Verified: June 2018
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
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Uric Acid
Rheumatoid Factor
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Immunologic Factors