Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2026-03-02 @ 6:41 PM
Study NCT ID:
NCT07046312
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-01
First Post:
2025-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Right Ventricular Strain in Detecting Subclinical Right Ventricular Systolic Dysfunction in Psoriatic Arthritis Patients: Relation to Serum Endostatin Level
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': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-29', 'studyFirstSubmitDate': '2025-05-19', 'studyFirstSubmitQcDate': '2025-06-29', 'lastUpdatePostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detecting subclinical right ventricular systolic dysfunction in PsA patients', 'timeFrame': 'Up to 24 months', 'description': 'Detecting subclinical right ventricular systolic dysfunction in PsA using 2D strain transthoracic echo and its relation to serum endostatin level'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psoriatic Arthritis (PsA)', 'Subclinical Right Ventricular Systolic Dysfunction']}, 'descriptionModule': {'briefSummary': 'The aim is to assess early right ventricular systolic dysfunction in psoriatic arthritis patients using RV strain echocardiography', 'detailedDescription': 'Previous studies evaluated RV strain for detection of subclinical RV affection due to PAH in systemic lupus erythematosus. However , to our knowledge , the study of RV strain and its possible association with serum endostatin to detect subclinical right ventricular systolic dysfunction and its relation to PAH in PsA patient is still a novel. Our aim is to assess early right ventricular systolic dysfunction in psoriatic arthritis patients using RV strain Echocardiography.\n\nTo evaluate serum endostatin as an objective biomarker for Pulmonary arterial hypertension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '30 patients with PsA and 30 matched healthy controls', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Psoriatic arthritis patients according to CASPAR criteria\n* Psoriatic arthritis patients without overt cardiovascular symptoms\n* Patients with age between 20 to 50 years of age\n\nExclusion Criteria:\n\n* Other systemic autoimmune diseases\n* Patients with a history of known valvular disease, atrial fibrillation or any other arrhythmia , heart failure, ischemic cardiomyopathy severe obstructive pulmonary diseases and metabolic syndrome.\n* Patients with medical disorders as renal, congenital heart diseases, hematological disorders and cancer patients.\n* Patients taking certain drugs that have been confirmed to be risk factors for PAH such as appetite suppressant intake drugs (aminorex, fenfluramine derivatives and benfluorex) and chemotherapeutic agents.\n* Family history of myocardial infarction, cerebrovascular disease or sudden death before the age of 65y in females and 55 y in males.'}, 'identificationModule': {'nctId': 'NCT07046312', 'briefTitle': 'Right Ventricular Strain in Detecting Subclinical Right Ventricular Systolic Dysfunction in Psoriatic Arthritis Patients: Relation to Serum Endostatin Level', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Right Ventricular Strain in Detecting Subclinical Right Ventricular Systolic Dysfunction in Psoriatic Arthritis Patients: Relation to Serum Endostatin Level', 'orgStudyIdInfo': {'id': 'MD13/2025'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control', 'description': '30 control group matched as regards BMI, age and sex will be subjected to transthoracic echo and measuring serum endostatin level.'}, {'label': 'Cases of Psoriatic arthritis patients', 'description': '30 PsA patients will be subjected to transthoracic echo, measuring serum endostatin level and modified composite psoriatic disease activity index'}]}, 'contactsLocationsModule': {'locations': [{'zip': '00202', 'city': 'Cairo', 'state': 'Abbassia', 'country': 'Egypt', 'facility': 'Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Dina Maamoun ElHadba, MSc Ain Shams University', 'role': 'CONTACT', 'email': 'DinaElhadba@med.asu.edu', 'phone': '01006780166'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}