Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-26 @ 12:40 AM
Study NCT ID:
NCT06413160
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-25
First Post:
2024-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Cardiovascular-Renal-Metabolic (CRM) Syndrome Survey in Jordan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Centrifuged plasma obtained from peripheral blood sample of the participants'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-23', 'studyFirstSubmitDate': '2024-05-06', 'studyFirstSubmitQcDate': '2024-05-09', 'lastUpdatePostDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of cardiovascular-renal-metabolic syndrome', 'timeFrame': 'From date of study entry through study completion, an average of 1 year', 'description': '1. CVD A. Coronary heart disease: Silent and clinical CAD (chronic stable coronary disease, acute coronary disease \\[ST-elevation myocardial infarction and non-ST-elevation acute coronary syndrome\\].\n\n B. Heart failure. C. Atrial fibrillation. D. Stroke. E. Peripheral artery disease\n2. Renal: chronic kidney disease\n3. Metabolic:\n\nA. Obesity/ B. Diabetes mellitus (DM).'}], 'secondaryOutcomes': [{'measure': 'Elevated levels of blood markers', 'timeFrame': 'From date of study entry through study completion, an average of 1 year', 'description': 'Elevated level of lipoprotein (a) , homocysteine, high sensitivity C-Reactive Protein, insulin resistance, and Urine Creatinine/Albumin ratio.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiovascular-renal-metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'Cardiovascular-renal-metabolic (CRM) syndrome is defined as a systemic disorder with a collection of related signs and symptoms attributable to the coexistence of multiple cardiovascular, renal and metabolic disease with a common underlying pathophysiology in one individual. Surveying this syndrome in a large population in Jordan aims at studying the risk factors, components and stages of the syndrome, thus helping early screening, diagnosing and treating disease and its risk factors.', 'detailedDescription': 'Cardiovascular-renal-metabolic (CRM) syndrome is defined as a systemic disorder with a collection of related signs and symptoms attributable to the coexistence of multiple cardiovascular, renal and metabolic disease with a common underlying pathophysiology in one individual.\n\nCRM syndrome reflects the intersection of cardiovascular disease with chronic kidney disease (CKD), and metabolic disease and risk factors (RF). A critical combination of these diseases and their risk factors in the same individual has a profound impact on quality of life and overall mortality. The clinical implications of the presence of CRM are significant, with premature morbidity and mortality, multiple organ-system disease, and high health care budgets mainly driven by the burden of cardiovascular disease (CVD).\n\nThere are high prevalence rates of all components of CRM and its RF on a global level and in the Middle East. Of note is the high prevalence of CV in the young, smoking, diabetes mellitus, obesity and dyslipidemia.\n\nThe current study will evaluate the prevalence of components and RF of CRM disease in a large population in North, central and South of Jordan.\n\nIn the Middle East, no systematic study has evaluated the definition of CRM, definition of its stages, and prevalence of its RF and its relation to the coexisting social determinants of health.\n\nThe study will provide new and contemporary knowledge on the definition, staging, and comprehensive approaches to care for patients with CRM, and subsequently exploring opportunities for prevention and care optimization by life style modification and pharmacotherapy.\n\nThere are different aspects that explain the interaction between the components of CRM. (A) The bidirectional association between the heart failure and the kidneys (cardiorenal syndrome) in addition to the risk of CAD in patients with CKD, (B) adipose tissue link to atherosclerosis mediated by inflammation, insulin resistance and endothelial dysfunction, and risk for DM (C) DM link to CVD, heart failure and kidney dysfunction., and many other links as well.\n\nScreening for CRM is an important pillar in promoting health in every community. The CRM staging system facilitates identifying individuals at progressive levels of severity starting from the preclinical phase to delay or avoid the onset of clinical CVD and CKD. To appropriately find individuals at stage 0 (i.e., asymptomatic stage) it is important to undertake active screening within the population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive individuals (N=10,000) visiting allocated medical laboratories in North, Center, and South sections of the country during public free blood testing campaigns planned in August 2024 to June 2025.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (age 18 years and above).\n* Willing to sign an informed consent.\n\nExclusion Criteria:\n\n* None.'}, 'identificationModule': {'nctId': 'NCT06413160', 'acronym': 'JoCRMSSurvey', 'briefTitle': 'The Cardiovascular-Renal-Metabolic (CRM) Syndrome Survey in Jordan', 'organization': {'class': 'OTHER', 'fullName': 'Jordan Collaborating Cardiology Group'}, 'officialTitle': 'The Cardiovascular-Renal-Metabolic (CRM) Syndrome Survey in Jordan', 'orgStudyIdInfo': {'id': 'CVA/JoCRM-2/2024'}}, 'contactsLocationsModule': {'locations': [{'zip': '11184', 'city': 'Amman', 'country': 'Jordan', 'contacts': [{'name': 'Ayman Hammoudeh, MD FACC', 'role': 'CONTACT', 'email': 'hammoudeh_ayman@yahoo.com', 'phone': '065001000'}], 'facility': 'Istishari Hospital', 'geoPoint': {'lat': 31.95522, 'lon': 35.94503}}], 'centralContacts': [{'name': 'Ayman Hammoudeh, MD, FACC', 'role': 'CONTACT', 'email': 'hammoudeh_ayman@yahoo.com', 'phone': '065001000'}, {'name': 'Imad A Alhaddad, MD, FACC', 'role': 'CONTACT', 'email': 'alhaddad63@gmail.com', 'phone': '065608080'}], 'overallOfficials': [{'name': 'Ayman Hammoudeh, MD, FACC', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Istisjhari Hospital'}, {'name': 'Imad A Alhaddad, MD, FACC', 'role': 'STUDY_CHAIR', 'affiliation': 'Jordan Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jordan Collaborating Cardiology Group', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cardiovascular Academy', 'class': 'UNKNOWN'}, {'name': 'The Association of Jordanian Medical Laboratory Specialists AJMLS', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Department of Clinical Research', 'investigatorFullName': 'Ayman J Hammoudeh, MD, FACC', 'investigatorAffiliation': 'Jordan Collaborating Cardiology Group'}}}}