Clinical trial NCT03821090: Rheumatoid Arthritis Disease Activity and Sub Clinical Atherosclerosis
Official title: A Study in Subclinical Atherosclerosis in Patients With Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-01-29
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
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 .

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

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

Eligibility criteria: 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.

Primary outcomes:
measure: detection of subclinical atherosclerosis in RA patients who have no cardiovascular risk factors
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university hospital
Study officials:
References:
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