- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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 .
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Stimato)
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
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).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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early Rheumatoid arthritis patients younger than 50 years of age
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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atherosclerosis assessment in early diagnosed Rheumatoid Arthritis
Lasso di tempo: • 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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Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Collegamenti utili
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Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie muscoloscheletriche
- Malattie vascolari
- Malattia cardiovascolare
- Artrite
- Malattie articolari
- Malattie reumatiche
- Malattie del tessuto connettivo
- Malattie autoimmuni
- Malattie del sistema immunitario
- Arteriosclerosi
- Malattie arteriose occlusive
- Malattie della pelle e del tessuto connettivo
- Artrite, reumatoide
- Aterosclerosi
Altri numeri di identificazione dello studio
- atherosclerosis in early RA
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .