Rheumatoid Arthritis Disease Activity and Sub Clinical Atherosclerosis

NCT03821090 | Completed

• 1 other identifier: cardiac affection in RA
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• detection of subclinical atherosclerosis in RA patients who have no cardiovascular risk factors

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

  baseline

Study Arms (2)

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(DAS28). 4-12-lead ECG 5-Echocardiography 6-Carotid intima media thickness using carotid doppler 7-Venous blood will be withdrawn to do the following laboratory tests 1.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. 3-12-lead ECG 4-Echocardiography 5-Carotid intima media thickness using carotid doppler 6-Venous blood will be withdrawn to do the following laboratory tests 1.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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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 .

You may qualify if:

• 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) .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university hospital

Asyut, 088, Egypt

Location

Related Publications (12)

• Ambrosino P, Lupoli R, Di Minno A, Tasso M, Peluso R, Di Minno MN. Subclinical atherosclerosis in patients with rheumatoid arthritis. A meta-analysis of literature studies. Thromb Haemost. 2015 May;113(5):916-30. doi: 10.1160/TH14-11-0921. Epub 2015 Feb 26.

  PMID: 25716931 BACKGROUND

• Baghdadi LR, Woodman RJ, Shanahan EM, Mangoni AA. The impact of traditional cardiovascular risk factors on cardiovascular outcomes in patients with rheumatoid arthritis: a systematic review and meta-analysis. PLoS One. 2015 Feb 17;10(2):e0117952. doi: 10.1371/journal.pone.0117952. eCollection 2015.

  PMID: 25689371 BACKGROUND

• Amar J, Fauvel J, Drouet L, Ruidavets JB, Perret B, Chamontin B, Boccalon H, Ferrieres J. Interleukin 6 is associated with subclinical atherosclerosis: a link with soluble intercellular adhesion molecule 1. J Hypertens. 2006 Jun;24(6):1083-8. doi: 10.1097/01.hjh.0000226198.44181.0c.

  PMID: 16685208 BACKGROUND

• Bradham WS, Bian A, Oeser A, Gebretsadik T, Shintani A, Solus J, Estis J, Lu QA, Todd J, Raggi P, Stein CM. High-sensitivity cardiac troponin-I is elevated in patients with rheumatoid arthritis, independent of cardiovascular risk factors and inflammation. PLoS One. 2012;7(6):e38930. doi: 10.1371/journal.pone.0038930. Epub 2012 Jun 28.

  PMID: 22761714 BACKGROUND

• deFilippi CR, de Lemos JA, Christenson RH, Gottdiener JS, Kop WJ, Zhan M, Seliger SL. Association of serial measures of cardiac troponin T using a sensitive assay with incident heart failure and cardiovascular mortality in older adults. JAMA. 2010 Dec 8;304(22):2494-502. doi: 10.1001/jama.2010.1708. Epub 2010 Nov 15.

  PMID: 21078811 BACKGROUND

• Gupta S, de Lemos JA. Use and misuse of cardiac troponins in clinical practice. Prog Cardiovasc Dis. 2007 Sep-Oct;50(2):151-65. doi: 10.1016/j.pcad.2007.01.002.

  PMID: 17765476 BACKGROUND

• Karpouzas GA, Malpeso J, Choi TY, Li D, Munoz S, Budoff MJ. Prevalence, extent and composition of coronary plaque in patients with rheumatoid arthritis without symptoms or prior diagnosis of coronary artery disease. Ann Rheum Dis. 2014 Oct;73(10):1797-804. doi: 10.1136/annrheumdis-2013-203617. Epub 2013 Jul 25.

  PMID: 23887286 BACKGROUND

• Lazzerini PE, Capecchi PL, Acampa M, Galeazzi M, Laghi-Pasini F. Arrhythmic risk in rheumatoid arthritis: the driving role of systemic inflammation. Autoimmun Rev. 2014 Sep;13(9):936-44. doi: 10.1016/j.autrev.2014.05.007. Epub 2014 May 27.

  PMID: 24874445 BACKGROUND

• Fransen J, Kazemi-Bajestani SM, Bredie SJ, Popa CD. Rheumatoid Arthritis Disadvantages Younger Patients for Cardiovascular Diseases: A Meta-Analysis. PLoS One. 2016 Jun 16;11(6):e0157360. doi: 10.1371/journal.pone.0157360. eCollection 2016.

  PMID: 27310259 BACKGROUND

• McInnes IB, Schett G. The pathogenesis of rheumatoid arthritis. N Engl J Med. 2011 Dec 8;365(23):2205-19. doi: 10.1056/NEJMra1004965. No abstract available.

  PMID: 22150039 BACKGROUND

• Navarro-Millan I, Yang S, DuVall SL, Chen L, Baddley J, Cannon GW, Delzell ES, Zhang J, Safford MM, Patkar NM, Mikuls TR, Singh JA, Curtis JR. Association of hyperlipidaemia, inflammation and serological status and coronary heart disease among patients with rheumatoid arthritis: data from the National Veterans Health Administration. Ann Rheum Dis. 2016 Feb;75(2):341-7. doi: 10.1136/annrheumdis-2013-204987. Epub 2015 Jan 21.

  PMID: 25609412 BACKGROUND

• Niemann-Jonsson A, Dimayuga P, Jovinge S, Calara F, Ares MP, Fredrikson GN, Nilsson J. Accumulation of LDL in rat arteries is associated with activation of tumor necrosis factor-alpha expression. Arterioscler Thromb Vasc Biol. 2000 Oct;20(10):2205-11. doi: 10.1161/01.atv.20.10.2205.

  PMID: 11031205 BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: January 27, 2019
• First Posted: January 29, 2019
• Study Start: April 15, 2019
• Primary Completion: March 1, 2021
• Study Completion: July 1, 2021
• Last Updated: January 25, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)