Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT05637905
Status:
UNKNOWN
Last Update Posted:
2022-12-06
First Post:
2022-11-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Monocyte Chemoattractant Protein-1 in Psoriatic Arthritis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015535', 'term': 'Arthritis, Psoriatic'}], 'ancestors': [{'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-25', 'studyFirstSubmitDate': '2022-11-25', 'studyFirstSubmitQcDate': '2022-11-25', 'lastUpdatePostDateStruct': {'date': '2022-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MCP-1', 'timeFrame': 'two month', 'description': ':Evaluate serum levels of monocyte chemoattractant protein-1(MCP-1) in relation to echocardiographic changes in patient with psoriatic arthritis.'}], 'secondaryOutcomes': [{'measure': 'Echocardiography', 'timeFrame': 'two month', 'description': 'b.Detect subclinical cardiovascular affaction in patient with psoriatic arthritis.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psoriatic Arthritis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://pubmed.ncbi.nlm.nih.gov/30910989/', 'label': '1.V.Chandran,F.Abji,A.V. Perruccio et al.,"Serum-basedsoluble markers difffferentiate psoriatic arthritis from osteoarthritis," Annals of the Rheumatic Diseases,vol.78, no.6, pp.796-801,2019.'}, {'url': 'http://pubmed.ncbi.nlm.nih.gov/30910989/', 'label': 'A. L. Carvalho and C. M. Hedrich, "The molecular pathophysiology of psoriatic arthritis-the complex interplay between genetic predisposition, epigenetics factors, and the microbiome," Frontiers in Molecular Biosciences, vol. 8, p. 662047, 2021.'}, {'url': 'http://pubmed.ncbi.nlm.nih.gov/30910989/', 'label': 'A. B. Gottlieb and J. F. Merola, "Axial psoriatic arthritis: an update for dermatologists," Journal of the American Academy of Dermatology, vol. 84, no. 1, pp. 92-101, 2021'}, {'url': 'http://pubmed.ncbi.nlm.nih.gov/30910989/', 'label': 'Lories RJ, de Vlam K. Is psoriatic arthritis a result of abnormalities in acquired or innate immunity? Curr Rheumatol Rep 2012; 14: 375-382.'}, {'url': 'http://pubmed.ncbi.nlm.nih.gov/30910989/', 'label': '.Lowes MA, Kikuchi T, Fuentes-Duculan J, Cardinale I, Zaba LC, Haider AS, et al. Psoriasis vulgaris lesions contain discrete populations of Th1 and Th17 T cells. J Invest Dermatol 2008; 128: 1207-12'}, {'url': 'http://pubmed.ncbi.nlm.nih.gov/30910989/', 'label': 'Risk Reclassification According to Cardiovascular Six Traditional Cardiovascular Risk Algorithms and a Carotid Ultrasound in Psoriatic Arthritis Patients'}, {'url': 'http://pubmed.ncbi.nlm.nih.gov/30910989/', 'label': 'A. Rana, V. K. Mahajan, K. S. Mehta et al., "Cardiomyopathy and echocardiographic abnormalities in Indian patients with psoriasis: results of a pilot study," International Journal of Clinical Practice, vol. 75, no. 3, p. e13756, 2021.'}, {'url': 'http://pubmed.ncbi.nlm.nih.gov/30910989/', 'label': 'P. S. Pagel, J. N. Tawil, B. T. Boettcher et al., "Heart failure with preserved ejection fraction: a comprehensive review and update of diagnosis,pathophysiology, treatment, and perioperative implications," Journal of Cardiothoracic and Vascular Anesthes'}, {'url': 'http://pubmed.ncbi.nlm.nih.gov/30910989/', 'label': '.E. L. Potter, S. Ramkumar, H. Kawakami et al., "Association of asymptomatic diastolic dysfunction assessed by left atrial strain with incident heart failure,"JACC: Cardiovascular Imaging, vol. 13, no. 11, pp. 2316-2326, 2020.'}, {'url': 'http://pubmed.ncbi.nlm.nih.gov/30910989/', 'label': 'Lin, V. Kakkar, and X. Lu, "Impact of MCP -1 in atherosclerosis," Current Pharmaceutical Design, vol. 20, no. 28, pp. 4580-4588, 2014.'}, {'url': 'http://pubmed.ncbi.nlm.nih.gov/30910989/', 'label': 'C. Papadopoulou, V. Corrigall, P. R. Taylor, and R. N. Poston, "The role of the chemokines MCP-1, GRO-α, IL-8 and their receptors in the adhesion of monocytic cells to human atherosclerotic plaques," Cytokine, vol. 43, no. 2, pp. 181-186, 2008.'}, {'url': 'http://pubmed.ncbi.nlm.nih.gov/30910989/', 'label': 'P. Aukrust, B. Halvorsen, A. Yndestad et al., "Chemokines and cardiovascular risk," Arteriosclerosis, Thrombosis, and Vascular Biology, vol. 28, no. 11, pp. 1909-1919'}, {'url': 'http://pubmed.ncbi.nlm.nih.gov/30910989/', 'label': 'D. E. Furst and J. S. Louie, "Targeting inflammatory pathways in axial spondyloarthritis," Arthritis Research \\& Therapy, vol. 21, no. 1, p. 135, 2019.'}, {'url': 'http://pubmed.ncbi.nlm.nih.gov/30910989/', 'label': 'Y. R. Woo, C. J. Park, H. Kang, and J. E. Kim, "The risk of systemic diseases in those with psoriasis and psoriatic arthritis:from mechanisms to clinic," International Journal of Molecular Sciences, vol. 21, no. 19, p. 7041, 2020.'}, {'url': 'http://pubmed.ncbi.nlm.nih.gov/30910989/', 'label': '.Moll JM, Wright V Psoriatic arthritis. Semin Arthritis Rheum 1973;3:55-78.CrossRefPubMedGoogle Scholar.'}]}, 'descriptionModule': {'briefSummary': '1. Evaluate serum levels of (MCP-1) in PsA with or without cardiovascular affaction .\n2. Detect subclinical cardiovascular affaction in patients with PsA for early diagnosis and management .', 'detailedDescription': 'Psoriatic arthritis (PSA) is an autoimmune disease arising from the interply between proinflamatory cytokines\n\n\\[1\\]and external stimuli in genetically predisposed individuals.\\[2\\]\n\n* The disease is chronic and affects the peripheral joints and may include axial skeleton with or without extrarticular manifestations.\\[3\\]\n* Abnormal activation of the innate and adaptive immune systems contributes to chronic disease processes in both psoriasis and PSA .\\[4\\] The skin and the joints exhibit a prominent lymphocytic infiltrate consisting of activated CD4+ and CD8+ T cells as well as an increase in neutrophil infiltration\\[5\\].\n\nPatients with PsA have a higher risk of developing a cardiovascular(CV) events than the general population. This could be attributed to the higher prevalence of traditional cardiovascular risk factors and to the disease characteristics such as systemic inflammation. \\[6\\] These patients may show asymptomatic cardiomyopathy even in the absence of traditional risk factors \\[7\\].Cardiac dysfunction is associated with a poor prognosis, increased mortality, and affact socioecenomic function of patients therefore, the diagnosis of the cardiac dysfunction in the asymptomatic phase of the disease \\[8\\] is important for the timely introduction of therapy \\[9\\].Monocyte chemotactic protien1(MCP-1) is a member of chemotactic chemokines(CC) which are secreted by immune effector cells and dysfunctional endothelium \\[10\\].\n\n* The pivotal function of MCP-1 is to attract monocyte in the arterial wall through increased expression of adhesion molecules on their surface that interacts with endothelium\\[11\\].\n* MCP-1 induce maturation of monocyte in the arterial wall ,which then become specialized macrophage in early atheroma and produce tissue factors supporting coagulation and proinflammatory cytokines such as IL-1 and IL-6. It affects the functions of the surrounding immune effector cells in locally thickened intima.\\[12\\]\n* During active disease in psoriatic skin lesions and synovial tissue, activated monocytes represent the major source of proinflammatory mediators, including the chemokine MCP-1 \\[13\\]. MCP-1 is thought to be involved in the pathogenesis of oedema and bone erosion in patients with PsA \\[14\\].'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'psoriatic arthritis patients with or without clinically cardiovascular affaction', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PsA patients (age ≥ 18years) who fulfilled the CASPAR classification criteria\\[15\\]for psoriatic arthritis\n\nExclusion Criteria:\n\n* PsA patients with\n\n 1. infection.\n 2. bone marrow disorders.\n 3. other autoimmune diseases.\n 4. diabetes.\n 5. hypertention .\n 6. hyperlipidemia.\n 7. liver diseases.\n 8. renal diseases.'}, 'identificationModule': {'nctId': 'NCT05637905', 'briefTitle': 'Monocyte Chemoattractant Protein-1 in Psoriatic Arthritis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'The Predictive Value of Monocyte Chemoattractant Protein -1 in the Development of Cardiovacular Events in Psoriatic Arthritis Patients', 'orgStudyIdInfo': {'id': 'MCP-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'psoriatic arthritis patients group'}, {'label': 'health control group'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Amira Anas, Master', 'role': 'CONTACT', 'email': 'amiraanas60@gmail.com', 'phone': '01066633924'}], 'overallOfficials': [{'name': 'Eman Abass, doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}, {'name': 'Mohamed Raouf, doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}, {'name': 'Esraa Ahmed, doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'doctor', 'investigatorFullName': 'Amira Anas Mostafa Mohamed', 'investigatorAffiliation': 'Assiut University'}}}}