Rheumatoid Arthritis Disease Activity and Sub Clinical Atherosclerosis

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT03821090
Collaborator
(none)
160
1
24
6.7

Study Details

Study Description

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 Intervention/Treatment Phase

    Detailed Description

    Rheumatoid arthritis (RA) is a chronic inflammatory autoimmune disease characterized by progressive joint destruction, associated with extra-articular manifestations, affecting different internal organs .

    Interestingly, these patients show an increased risk of mortality when compared to general population and recent evidence clearly confirmed that this risk is largely due to cerebro-cardiovascular events (CV Es), this may be explained by the greater prevalence, severity, burden and different composition of occult coronary lesions in RA compared with age- and gender-matched controls.

    RA is associated with traditional CV risk factors ,subclinical atherosclerosis,arrhythmias , and coronary calcifications .

    Increased subclinical atherosclerosis, mainly carotid artery plaques, may be observed in RA patients, the increased carotid intima-media thickness (cIMT) and presence of plaques are accepted as strong predictors of generalized atherosclerosis and major CVEs in both non-RA and RA subjects.

    The evidence of traditional CV risk factors and subclinical atherosclerosis does not fully explain the increased incidence of CVEs in these patients; suggesting that the CV risk may be independently associated with RA and in fact, this risk has been shown to be associated with additional features specific of RA, such as the systemic inflammatory process, disease duration and therapeutic strategies .

    Chronic inflammation and high disease activity are reportedly associated with atherosclerotic burden, higher incidence of cerebrovascular disease (CVD), chronic heart failure (CHF), and mortality of patients with RA . Residual disease activity may further associate with more advanced, complex and prone-to-rupture coronary plaques .

    Pro-inflammatory cytokines such as tumor necrosis factor alpha (TNF-α), reflect clinical activity and structural damage in RA and are elevated in the blood of RA patients compared with controls , the same cytokine have been identified in atherosclerotic plaque and correlated with subclinical atherosclerosis independent of cardiac risk factors coronary plaque complexity , plaque destabilization and CVEs in subjects without autoimmune disease .

    Cardiac troponins (cTn) are components of the cardiomyocyte contractile apparatus, and circulating concentrations are elevated in the setting of myocardial injury, such as acute coronary syndromes (ACS) .

    High-sensitivity (hs) cTn assays allow measurement of troponin concentrations below conventional levels of detection and have revealed a spectrum of circulating cTn concentrations spanning low and high levels in both healthy subjects and in patients with overt cardiovascular disease

    Additionally, both high-sensitivity cardiac troponin T (hs-cTnT) and high-sensitivity cardiac troponin I (hs-cTnI) predicted a greater risk of fatal and non-fatal coronary heart disease, heart failure hospitalization and overall mortality in the general population .

    Aim of the study

    1. Detection of subclinical atherosclerosis in RA patients by means of carotid Doppler

    2. Detection of level of high sensitive cardiac troponin I in RA patients and it΄s relation to sub clinical atherosclerosis and disease activity

    3. Correlation between high sensitive cardiac troponin I and TNF α as a pro inflammatory cytokine to the presence of subclinical atherosclerosis in RA patients

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    160 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Other
    Official Title:
    A Study in Subclinical Atherosclerosis in Patients With Rheumatoid Arthritis
    Actual Study Start Date :
    Jul 1, 2019
    Actual Primary Completion Date :
    Mar 1, 2021
    Actual Study Completion Date :
    Jul 1, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    cases

    Eighty rheumatoid arthritis patients fulfilling American College of Rheumatology (ACR) 2010 classification criteria, all of them will be subjected to History including disease duration , course and associated diseases Clinical examination with specific joint examination RA disease activity will be evaluated by a 28- joint DAS (DAS28). 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 CBC ESR &CRP RF& Anti-ccp Urine analysis , Urea and creatinine , and GFR Uric acid level Lipogram HA1C TNF α High sensitive cardiac troponin I (hs-cTnI)

    control

    Eighty healthy subjects age and sex matched will be included , all of them will be subjected to History Clinical examination . 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 Complete Blood Count (CBC) Erythrocyte Sedimentation Rate (ESR) &C Reactive Protein(CRP) Rheumatoid Factor (RF)& Anti-ccp Urine analysis , Urea and creatinine , and Glomerular Filtration Rate(GFR) Uric acid level Lipogram HA1C TNF α High sensitive cardiac troponin I (hs-cTnI)

    Outcome Measures

    Primary Outcome Measures

    1. detection of subclinical atherosclerosis in RA patients who have no cardiovascular risk factors [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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 .
    Exclusion Criteria:
    • Rheumatoid arthritis with concomitant autoimmune disease Chronic liver or kidney diseases , Chronic or active infections malignancy Hypertension Smoking Obesity Diabetes mellitus .

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assiut university hospital Assiut Egypt 088

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Sabrin Refaat Mahmoud, principle investigator, Assiut University
    ClinicalTrials.gov Identifier:
    NCT03821090
    Other Study ID Numbers:
    • cardiac affection in RA
    First Posted:
    Jan 29, 2019
    Last Update Posted:
    Aug 20, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 20, 2021