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- Essai clinique NCT07772466
Atherosclerosis in Early Rheumatoid Arthritis Patients Using Atherogenic Index of the Plasma and Carotid Intima Media Thickness
Atherogenic Index of Plasma and Carotid Intima-media Thickness as Predictors of Preclinical Atherosclerosis in Early Rheumatoid Arthritis Patients Younger Than 50 Years of Age
Rheumatoid arthritis (RA) is a chronic systemic autoimmune disease primarily affecting the peripheral joints, yet its extra-articular burden particularly on the cardiovascular (CV) system has emerged as its most consequential long-term complication . Cardiovascular disease (CVD) accounts for 40% of all deaths in RA patients, making it the leading cause of mortality .This excess CV risk is estimated to be 1.5 to 2 times higher than in the general population .The overall CV risk conferred by RA has been linked in magnitude to that of diabetes mellitus, underscoring RA as an independent cardiovascular risk factor formally recognised in the 2021 European Society of Cardiology Guidelines on CVD prevention .
In this context, the non-invasive detection of preclinical atherosclerosis before the onset of clinical CV events has become clinical priority. Carotid intima-media thickness (CIMT), measured by high-resolution B-mode ultrasonography, is a well-validated surrogate marker of early structural arterial wall changes that independently predicts future myocardial infarction and stroke .Multiple studies have documented significantly elevated CIMT in RA patients compared with age- and sex-matched controls; studies found higher CIMT values across all age groups in RA, with values increasing in proportion to disease severity as assessed by the Disease Activity Score in 28 joints .
The atherogenic index of plasma (AIP) defined as the base-10 logarithm of the triglyceride-to-HDL-cholesterol ratio has emerged as a calculated composite biomarker reflecting lipoprotein particle atherogenicity, particularly the preponderance of small, dense LDL particles .A high AIP (>0.21) has been independently associated with major adverse cardiovascular events beyond the predictive capacity of conventional lipid panels .
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
for cases (Rheumatoid Arthritis patients)
- Patients fulfilling the 2010 American College of Rheumatology / European League Against Rheumatism (ACR/EULAR) classification criteria for RA
- Disease duration of ≤6 months from the onset of symptoms (early RA)
For Controls (Healthy Subjects):
- Healthy volunteers aged 18 to 49 years with no known inflammatory, autoimmune, or chronic disease.
- Age- and sex-matched (within ±2 years) to case subjects
Exclusion Criteria:
- Established cardiovascular disease (coronary artery disease, prior myocardial infarction, stroke, peripheral arterial disease, or heart failure).
- Diabetes mellitus, Hypertension, and Dyslipidaemia on lipid-lowering therapy (statins, fibrates, niacin, or omega-3 agents), as these agents directly modify AIP values.
- Chronic kidney disease (eGFR <60 mL/min/1.73 m²) and Hepatic disease, thyroid dysfunction, or any other significant endocrine disorder.
- Pregnancy or lactation.
- Other connective tissue diseases (systemic lupus erythematosus, systemic sclerosis, Sjögren's syndrome).
- Other inflammatory arthropathies (psoriatic arthritis, ankylosing spondylitis, reactive arthritis).
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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early Rheumatoid arthritis patients younger than 50 years of age
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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atherosclerosis assessment in early diagnosed Rheumatoid Arthritis
Délai: • Disease duration of ≤6 months from the onset of symptoms
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• Disease duration of ≤6 months from the onset of symptoms
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Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- Rajabzadeh F, Akhlaghipour I, Moosavi SS, Nasimi Shad A, Babazadeh Baghan A, Shariati-Sarabi Z, Payandeh A, Hassan Nejad E. Comparison of the intima-media thickness of the common carotid artery in patients with rheumatoid arthritis: A single-center cross-sectional case-control study, and a brief review of the literature. Health Sci Rep. 2023 Nov 16;6(11):e1718. doi: 10.1002/hsr2.1718. eCollection 2023 Nov.
- Xu C, Xu S, Mai P, Tang J, Xu J, Zhang H. Association between the atherogenic index of plasma and abdominal aortic calcification in adults: a cross-sectional study. BMC Public Health. 2024 Sep 6;24(1):2431. doi: 10.1186/s12889-024-19862-3.
- Drosos AA, Venetsanopoulou AA, Pelechas E, Voulgari PV. Exploring Cardiovascular Risk Factors and Atherosclerosis in Rheumatoid Arthritis. Eur J Intern Med. 2024 Oct;128:1-9. doi: 10.1016/j.ejim.2024.07.016. Epub 2024 Jul 23.
- Solomon DH, Demler O, Rist PM, Santacroce L, Tawakol A, Giles JT, Liao KP, Bathon JM. Biomarkers of Cardiovascular Risk in Patients With Rheumatoid Arthritis: Results From the TARGET Trial. J Am Heart Assoc. 2024 Mar 5;13(5):e032095. doi: 10.1161/JAHA.123.032095. Epub 2024 Feb 28.
- Farhat H, Irfan H, Muthiah K, Pallipamu N, Taheri S, Thiagaraj SS, Shukla TS, Gutlapalli SD, Giva S, Penumetcha SS. Increased Risk of Cardiovascular Diseases in Rheumatoid Arthritis: A Systematic Review. Cureus. 2022 Dec 8;14(12):e32308. doi: 10.7759/cureus.32308. eCollection 2022 Dec.
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies musculo-squelettiques
- Maladies vasculaires
- Maladies cardiovasculaires
- Arthrite
- Maladies articulaires
- Maladies rhumatismales
- Maladies du tissu conjonctif
- Maladies auto-immunes
- Maladies du système immunitaire
- Artériosclérose
- Maladies artérielles occlusives
- Maladies de la peau et du tissu conjonctif
- Arthrite, rhumatoïde
- Athérosclérose
Autres numéros d'identification d'étude
- atherosclerosis in early RA
Informations sur les médicaments et les dispositifs, documents d'étude
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