LA Function and Dimensions As Predictors of Disease Activity in RA

NCT06593990 | Not Yet Recruiting

• 1 other identifier: Left atrial function in RA
• Study Type: observational
• Target: 108
• Locations: 0 countries
• Sites: N/A

Brief Summary

the aim of this study is to

• describe subclinical echocardiographic changes of the LA (dimensions and function) in patients with rheumatoid arthritis.
• evaluate the correlation between Rheumatoid arthritis activity and subclinical structural changes of LA.
• determine the association of LA volume index and atrial fibrillation or HFpf in RA patients.
• apply Musculoskeletal Ultrasound detected synovitis to be correlated with cardiac function.

Conditions

Rhematoid Arthritis

Keywords

left atrial function; rhematoid arthritis; musculoskeletal ultrasound; echocardiographic changes in rhematoid arthritis

Outcome Measures

Primary Outcomes (2)

• • Detect echocardiographic abnormalities in patients with rheumatoid arthritis

  * Detect echocardiographic abnormalities in patients with rheumatoid arthritis. * Detect subclinical echocardiographic changes of the LA (dimensions and function) in patients with rheumatoid arthritis.. * Evaluate the correlation between Rheumatoid arthritis and increased heart failure risk.

  4 hours

• perform musculoskeletal Ultrasound detected synovitis to be correlated with cardiac function.

  4 hours

Secondary Outcomes (1)

• • Evaluation of the LA function and dimensions, parallel to the evaluation of disease activity in RA patients, to detect possible association between disease activity and subclinical LA affection.

  4 hours

Interventions

echocardography DEVICE

Patients will be subjected to transthoracic echocardiography including, the following parameters will be measured: * Left ventricular (LV) dimensions: end diastolic and systolic dimensions and LV ejection fraction (EF). * Trans- mitral Doppler flow velocities including early (E) and late(A) diastolic velocities, E/A ratio. * LA anteroposterior diameter measure from 2D parasternal long axis view targeted M-mode. * LA superior-inferior and medio-lateral diameters measure from the apical 4 chamber view. * LA volume included: * Maximal LA volume measure at the end of systole * Minimal LA volume will be measured at end diastole just at the closure of the mitral valve. * Pre contractile LA volume ( LAV pre-A\] measured at P-wave onset on ECG just before atrial contraction.

Also known as: musculoskeletal ultrasound

musculoskeletal ultrasonography DEVICE

Ultrasound detected synovitis t

lipid profile test DIAGNOSTIC_TEST

The lipid profile typically includes measurement of total cholesterol, HDL-cholesterol (often called good cholesterol), LDL-cholesterol (often called bad cholesterol), and triglycerides.

C reactive protein DIAGNOSTIC_TEST

A c-reactive protein test measures the level of c-reactive protein (CRP) in a sample of your blood. CRP is a protein that your liver makes. Normally, you have low levels of c-reactive protein in your blood. Your liver releases more CRP into your bloodstream if you have inflammation in your body. High levels of CRP may mean you have a serious health condition that causes inflammation.

Complete blood count CBC DIAGNOSTIC_TEST

A complete blood count, or CBC, is a blood test that measures many different parts and features of your blood, including: Red blood cells, which carry oxygen from your lungs to the rest of your body. White blood cells, which fight infections and other diseases. There are five major types of white blood cells. A CBC test measures the total number of white cells in your blood. A different test called a CBC with differential measures the number of each type of these white blood cells. Platelets, which stop bleeding by helping your blood to clot. Hemoglobin, a protein in red blood cells that carries oxygen from your lungs to the rest of your body. Hematocrit, a measurement of how much of your blood is made up of red blood cells. Mean corpuscular volume (MCV), a measure of the average size of your red blood cells.

Erythrocyte sedimentation rate (ESR). DIAGNOSTIC_TEST

An erythrocyte sedimentation rate (ESR) is a blood test that that can show if you have inflammation in your body. Inflammation is your immune system\'s response to injury, infection, and many types of conditions, including immune system disorders, certain cancers, and blood disorders.

x ray of the hand DEVICE

The X-ray may show a hand with advanced rheumatoid arthritis. \"Bone erosion\" means cartilage and bone are worn away. \"Bone displacement\" means that a bone has moved out of its normal position. This X-ray shows how bone erosion and bone displacement can change the shape of the hand.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The participants will be from rheumatology unit, Internal Medicine Department at Assiut University Hospitals and its outpatient clinic

You may qualify if:

• \- 1- Patients with RA (aged \>18 years and duration of RA disease \>1 year) come to the rheumatology/ Internal medicine department or outpatient clinics at Assiut University Hospital.
• RA are diagnosed based on the ACR/EULAR 2010 rheumatoid arthritis classification criteria if a total score of ≥6 is needed to classify a patient as having definite RA

You may not qualify if:

• Patients with known history of atherosclerotic heart disease.
• Patients with overlap syndrome.
• Patients with hypothyroidism, Cushing's syndrome, anemia, and severe hepatic or renal dysfunction

Sponsors & Collaborators

• Assiut University: lead

Related Publications (13)

• Erre GL, Chessa I, Bassu S, Cavagna L, Carru C, Pintus G, Giordo R, Mangoni AA, Damiano Sanna G, Zinellu A. Association between ischemia-modified albumin (IMA) and peripheral endothelial dysfunction in rheumatoid arthritis patients. Sci Rep. 2024 Feb 17;14(1):3964. doi: 10.1038/s41598-024-54641-5.

  PMID: 38368495 BACKGROUND

• Takase-Minegishi K, Horita N, Kobayashi K, Yoshimi R, Kirino Y, Ohno S, Kaneko T, Nakajima H, Wakefield RJ, Emery P. Diagnostic test accuracy of ultrasound for synovitis in rheumatoid arthritis: systematic review and meta-analysis. Rheumatology (Oxford). 2018 Jan 1;57(1):49-58. doi: 10.1093/rheumatology/kex036.

  PMID: 28340066 BACKGROUND

• Wang YW, Chen JF, Ko CH, Cheng TT, Chiu WC, Yu SF, Hsu CY, Chen YC. Factors associated with subclinical inflammation of wrist joints in rheumatoid arthritis patients with low or no disease activity- a RA ultrasound registry study. BMC Musculoskelet Disord. 2023 May 30;24(1):438. doi: 10.1186/s12891-023-06521-8.

  PMID: 37254118 BACKGROUND

• Chen CC, Chen DY. The Clinical Utility of Musculoskeletal Ultrasound for Disease Activity Evaluation and Therapeutic Response Prediction in Rheumatoid Arthritis Patients: A Narrative Review. J Med Ultrasound. 2023 Nov 10;31(4):275-281. doi: 10.4103/jmu.jmu_126_22. eCollection 2023 Oct-Dec.

  PMID: 38264607 BACKGROUND

• Sudol-Szopinska I, Jans L, Teh J. Rheumatoid arthritis: what do MRI and ultrasound show. J Ultrason. 2017 Mar;17(68):5-16. doi: 10.15557/JoU.2017.0001. Epub 2017 Mar 31.

  PMID: 28439423 BACKGROUND

• Pisaniello HL, Whittle SL, Lester S, Menz F, Metcalf R, McWilliams L, Hill CL, Proudman S. Using the derived 28-joint disease activity score patient-reported components (DAS28-P) index as a discriminatory measure of response to disease-modifying anti-rheumatic drug therapy in early rheumatoid arthritis. BMC Rheumatol. 2022 Nov 15;6(1):67. doi: 10.1186/s41927-022-00299-3.

  PMID: 36376988 BACKGROUND

• McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Böhm M, et al. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: Developed by the Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC) With the special contribution of the Heart Failure Association (HFA) of the ESC. European heart journal. 2021;42(36):3599-72

  BACKGROUND

• Makavos G, Varoudi M, Papangelopoulou K, Kapniari E, Plotas P, Ikonomidis I, Papadavid E. Echocardiography in Autoimmune Rheumatic Diseases for Diagnosis and Prognosis of Cardiovascular Complications. Medicina (Kaunas). 2020 Sep 1;56(9):445. doi: 10.3390/medicina56090445.

  PMID: 32883041 BACKGROUND

• Foglieni C, Rusconi R, Mantione ME, Fragasso G, Alfieri O, Maisano F. Early left atrial tissue features in patients with chronic mitral regurgitation and sinus rhythm: Alterations of not remodeled left atria. Int J Cardiol. 2016 Sep 15;219:433-8. doi: 10.1016/j.ijcard.2016.06.047. Epub 2016 Jun 15.

  PMID: 27372606 BACKGROUND

• Corrao S, Messina S, Pistone G, Calvo L, Scaglione R, Licata G. Heart involvement in rheumatoid arthritis: systematic review and meta-analysis. Int J Cardiol. 2013 Sep 1;167(5):2031-8. doi: 10.1016/j.ijcard.2012.05.057. Epub 2012 Jun 15.

  PMID: 22703938 BACKGROUND

• Park E, Bathon J. Cardiovascular complications of rheumatoid arthritis. Curr Opin Rheumatol. 2024 May 1;36(3):209-216. doi: 10.1097/BOR.0000000000001004. Epub 2024 Feb 9.

  PMID: 38334476 BACKGROUND

• Sanghavi N, Ingrassia JP, Korem S, Ash J, Pan S, Wasserman A. Cardiovascular Manifestations in Rheumatoid Arthritis. Cardiol Rev. 2024 Mar-Apr 01;32(2):146-152. doi: 10.1097/CRD.0000000000000486. Epub 2022 Nov 21.

  PMID: 36729119 BACKGROUND

• Lin YJ, Anzaghe M, Schulke S. Update on the Pathomechanism, Diagnosis, and Treatment Options for Rheumatoid Arthritis. Cells. 2020 Apr 3;9(4):880. doi: 10.3390/cells9040880.

  PMID: 32260219 BACKGROUND

Related Links

• Related Info

MeSH Terms

Interventions

Blood Cell Count; Blood Sedimentation

Intervention Hierarchy (Ancestors)

Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Salwa salah elgendi, MD

  assuit univeristy hospitals

  STUDY DIRECTOR

• Taghreed sayed Meshref, MD

  assuit univeristy hospitals

  STUDY DIRECTOR

• Abdelhafeez Mohmoud Moshrif, MD

  Al-Azhar faculty of medicine

  STUDY DIRECTOR

Central Study Contacts

mohammed ragab osman, master degree

CONTACT

00201111629207; mohammedragab740@gmail.com

Taghreed Sayed Meshref, MD

CONTACT

00201003651135; Taghreed.Meshref@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer in assiut university

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share