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Rheumatoid Arthritis Disease Activity and Sub Clinical Atherosclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03821090
Recruitment Status : Not yet recruiting
First Posted : January 29, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Sabrin Refaat Mahmoud, Assiut University

Brief Summary:

RA is associated with traditional cerebrovascular risk factors as subclinical atherosclerosis.

Chronic inflammation and high disease activity are associated with atherosclerotic burden, higher incidence of cerebrovascular disease ,chronic heart failure , and mortality of patients with RA .

High-sensitivity cardiac troponin I (hs-cTnI) predicted a greater risk coronary heart disease, heart failure hospitalization and overall mortality in the general population .

So the aim of the study is to correlate between high sensitive cardiac troponin I and disease activity to the presence of subclinical atherosclerosis in RA patients


Condition or disease
Rheumatoid Arthritis

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Other
Official Title: A Study in Subclinical Atherosclerosis in Patients With Rheumatoid Arthritis
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine


Group/Cohort
cases

Eighty rheumatoid arthritis patients fulfilling American College of Rheumatology (ACR) 2010 classification criteria, all of them will be subjected to

  1. History including disease duration , course and associated diseases
  2. Clinical examination with specific joint examination
  3. RA disease activity will be evaluated by a 28- joint DAS (DAS28).
  4. The Framingham 10 year risk of general cardiovascular disease score will be calculated 5-12-lead ECG

6-Echocardiography 7-Carotid intima media thickness (cIMT)using carotid doppler 8-Venous blood will be withdrawn to do the following laboratory tests

  1. CBC
  2. ESR &CRP
  3. RF& Anti-ccp
  4. Urine analysis , Urea and creatinine , and GFR
  5. Uric acid level
  6. Homocystine
  7. Lipogram
  8. HA1C
  9. TNF α
  10. High sensitive cardiac troponin I (hs-cTnI)
control

fifty healthy subjects age and sex matched will be included , all of them will be subjected to

  1. History
  2. Clinical examination .
  3. The Framingham 10 year risk of general cardiovascular disease score will be calculated 4-12-lead ECG

5-Echocardiography 6-Carotid intima media thickness (cIMT)using carotid doppler 8-Venous blood will be withdrawn to do the following laboratory tests

  1. Complete Blood Count (CBC)
  2. Erythrocyte Sedimentation Rate (ESR) &C Reactive Protein(CRP)
  3. Rheumatoid Factor (RF)& Anti-ccp
  4. Urine analysis , Urea and creatinine , and Glomerular Filtration Rate(GFR)
  5. Uric acid level
  6. Homocystine
  7. Lipogram
  8. HA1C
  9. TNF α
  10. High sensitive cardiac troponin I (hs-cTnI)



Primary Outcome Measures :
  1. detection of subclinical atherosclerosis in RA patients who have no cardiovascular risk factors [ Time Frame: baseline ]
    Correlation between high sensitive cardiac troponin I and TNF α as a pro inflammatory cytokine to the presence of subclinical atherosclerosis in RA patients who have no cardiovascular risk factors



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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:   Non-Probability Sample
Study Population
Eighty rheumatoid arthritis patients fulfilling ACR 2010 classification criteria will be in rolled in the study also fifty healthy subjects age and sex matched will be included .
Criteria

Inclusion Criteria:

  • RA patients fulfilling ACR 2010 classification criteria with age from 20 years and above with no history of cardiovascular disease, including myocardial infarction, revascularization , heart failure, transient ischemic attacks , stroke or peripheral arterial disease.

Exclusion Criteria:

  • Rheumatoid arthritis with concomitant autoimmune disease Chronic liver or kidney diseases , Chronic or active infections malignancy Hypertension Smoking Obesity Diabetes mellitus .

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): NCT03821090


Contacts
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Contact: Sabrin R Mahmoud, assistant lecturer +2001019017960 sabrinref3t89@gmail.com

Sponsors and Collaborators
Assiut University
Publications:

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Responsible Party: Sabrin Refaat Mahmoud, principle investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03821090    
Other Study ID Numbers: cardiac affection in RA
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 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
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Atherosclerosis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases