Rheumatoid Arthritis Disease Activity and Sub Clinical Atherosclerosis

January 23, 2023 updated by: Sabrin Refaat Mahmoud, Assiut University

A Study in Subclinical Atherosclerosis in Patients With Rheumatoid Arthritis

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 , TNF-α to disease activity and presence of subclinical atherosclerosis in RA patients

Study Overview

Status

Completed

Conditions

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 levels of high sensitive cardiac troponin I and TNF-α in RA patients
  3. Correlation between high sensitive cardiac troponin I and TNF- α to disease activity and to the presence of subclinical atherosclerosis in RA patients

Study Type

Observational

Enrollment (Actual)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 088
        • Assiut University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Eighty rheumatoid arthritis patients fulfilling ACR 2010 classification criteria will be in rolled in the study also eighty healthy subjects age and sex matched will be included .

Description

Inclusion Criteria:

  • RA patients fulfilling ACR 2010 classification criteria over the age of 18 who have active RA (either early with symptoms lasting < 6 months or established disease lasting > 6 months) .

Exclusion Criteria:

Patients who have previously experienced cardiovascular illness, e.g., heart failure, acute coronary syndrome, revascularization, transient ischemic attacks, and cerebrovascular stroke. Patients who have concomitant hepatic or renal diseases, active infections, malignancy, smoking, hypertension, dyslipidemia, obesity, diabetes mellitus, and hyperuricemia. Patients who are receiving anti-TNF-α therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Other

Cohorts and Interventions

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). 4-12-lead ECG

5-Echocardiography 6-Carotid intima media thickness using carotid doppler 7-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 cyclic citrullinated peptide (Anti-CCP)
  4. Urine analysis , Urea and creatinine ,
  5. Uric acid level
  6. Lipogram
  7. HA1C
  8. TNF α
  9. hs-cTnI
control

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

  1. History
  2. Clinical examination . 3-12-lead ECG

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

  1. Complete Blood Count (CBC)
  2. ESR & CRP
  3. RF& Anti-CCP
  4. Urine analysis , Urea and creatinine
  5. Uric acid level
  6. Lipogram
  7. HA1C
  8. TNF α
  9. hs-cTnI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 to disease activity and presence of subclinical atherosclerosis in RA patients
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2019

Primary Completion (Actual)

March 1, 2021

Study Completion (Actual)

July 1, 2021

Study Registration Dates

First Submitted

January 27, 2019

First Submitted That Met QC Criteria

January 27, 2019

First Posted (Actual)

January 29, 2019

Study Record Updates

Last Update Posted (Estimate)

January 25, 2023

Last Update Submitted That Met QC Criteria

January 23, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • cardiac affection in RA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe