Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 5:11 AM
Study NCT ID:
NCT06655493
Status:
COMPLETED
Last Update Posted:
2025-10-21
First Post:
2024-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Levels of Inflammation in Middle East People With Cardiovascular Disease With/Without Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 756}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-08-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-20', 'studyFirstSubmitDate': '2024-10-21', 'studyFirstSubmitQcDate': '2024-10-21', 'lastUpdatePostDateStruct': {'date': '2025-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'High Sensitivity C-Reactive Protein (hsCRP) ≥2 mg/L', 'timeFrame': 'At Visit (day 0)', 'description': 'Count of patients'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Systemic Inflammation (hsCRP)']}, 'descriptionModule': {'briefSummary': 'This study will collect medical and background information from participants with diseases that affect the heart and blood vessels (cardiovascular disease) with/without kidney disease.\n\nThe aim of the study is to assess the number of people with high levels of systemic inflammation among Middle East people with cardiovascular with/without kidney disease. Systemic inflammation means that it occurs throughout the body.\n\nParticipation in this study only requires a single visit at the clinic/hospital/medical institution. Participants will continue their normal care and will not get any treatment as part of this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A cohort of patients with HF and a cohort of patients with ASCVD and CKD in the Middle East', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).\n2. Male or female, age above or equal to 18 years at the time of signing informed consent.\n3. Diagnosed with ASCVD+CKD and/or HF (pEF or mrEF)\n\nExclusion Criteria:\n\n1. Previous participation in this study. Participation is defined as having given informed consent in this study.\n2. Current participation (i.e., signed informed consent) in any other interventional clinical study.\n3. Any hospitalization or unplanned visit within the last 60 days (including exacerbation of chronic disease with hospitalization).\n4. Clinical evidence, or suspicion of, active infection within the last 60 days.\n5. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.'}, 'identificationModule': {'nctId': 'NCT06655493', 'acronym': 'INFLAMEAST', 'briefTitle': 'Levels of Inflammation in Middle East People With Cardiovascular Disease With/Without Kidney Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Cross-sectional Study to Investigate Prevalence of Systemic Inflammation (hsCRP) in Cohort of Patients With HF and a Cohort of Patients With ASCVD and CKD in the Middle East', 'orgStudyIdInfo': {'id': 'DAS-8043'}, 'secondaryIdInfos': [{'id': 'U1111-1303-1767', 'type': 'OTHER', 'domain': 'World Health Organization (WHO)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'ASCVD with CKD', 'description': 'Study participants diagnosed with Atherosclerotic Cardiovascular Disease (ASCVD) with Chronic Kidney Disease (CKD)', 'interventionNames': ['Other: No treatment given']}, {'label': 'HFpEF or HFmrEF', 'description': 'Study participants diagnosed with Heart Failure (HF) with preserved ejection fraction (HFpEF) or HF with mildly reduced ejection fraction (HFmrEF)', 'interventionNames': ['Other: No treatment given']}], 'interventions': [{'name': 'No treatment given', 'type': 'OTHER', 'description': 'Participants will continue their normal care and will not get any treatment as part of this study.', 'armGroupLabels': ['ASCVD with CKD', 'HFpEF or HFmrEF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36342', 'city': 'Al Ahsa', 'country': 'Saudi Arabia', 'facility': 'Almoosa Specialist Hospital'}, {'zip': '23311', 'city': 'Jeddah', 'country': 'Saudi Arabia', 'facility': 'King Fahad Armed Forces, Jeddah', 'geoPoint': {'lat': 21.49012, 'lon': 39.18624}}, {'zip': '23433', 'city': 'Jeddah', 'country': 'Saudi Arabia', 'facility': 'King Faisal Specialist Hospital & Research Centre, Jeddah', 'geoPoint': {'lat': 21.49012, 'lon': 39.18624}}, {'zip': '12214', 'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'Dr. Sulaiman Al Habib Medical Group- Olaya', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}, {'zip': '12372', 'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'King Khaled University Hospital,King Saud Univ. Med. City', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}, {'zip': '12381', 'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'Dallah Hospital_Riyadh', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}, {'zip': '12713', 'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'King Faisal Specialist Hospital & Research Centre, Riyadh', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}, {'zip': '13215', 'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'SMC, Riyadh', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}, {'zip': '59046', 'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'King Fahad Medical City', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}, {'zip': '47512', 'city': 'Tabuk', 'country': 'Saudi Arabia', 'facility': 'King Salman North Western Armed Force Hospital (NWAFH)', 'geoPoint': {'lat': 28.3998, 'lon': 36.57151}}, {'zip': '112412', 'city': 'Abu Dhabhi', 'country': 'United Arab Emirates', 'facility': 'Cleveland Clinic Abu Dhabi'}, {'zip': '15258', 'city': 'Abu Dhabhi', 'country': 'United Arab Emirates', 'facility': 'Tawam Hospital (SEHA)'}, {'zip': '46713', 'city': 'Abu Dhabhi', 'country': 'United Arab Emirates', 'facility': 'Mediclinic Abu Dhabi'}, {'zip': '48338', 'city': 'Abu Dhabhi', 'country': 'United Arab Emirates', 'facility': 'Imperial college, Abu Dhabi'}, {'zip': '123456', 'city': 'Dubai', 'country': 'United Arab Emirates', 'facility': 'Tadwai hospital', 'geoPoint': {'lat': 25.07725, 'lon': 55.30927}}, {'zip': '4545', 'city': 'Dubai', 'country': 'United Arab Emirates', 'facility': 'Rashid Hospital', 'geoPoint': {'lat': 25.07725, 'lon': 55.30927}}, {'zip': '7272', 'city': 'Dubai', 'country': 'United Arab Emirates', 'facility': 'Dubai Hospital', 'geoPoint': {'lat': 25.07725, 'lon': 55.30927}}, {'zip': '12345', 'city': 'Fujairah', 'country': 'United Arab Emirates', 'facility': 'Fujairah Hospital', 'geoPoint': {'lat': 25.11641, 'lon': 56.34141}}, {'zip': '12345', 'city': 'Fujairah', 'country': 'United Arab Emirates', 'facility': 'Sheikh Khalifa Hospital Fujairah', 'geoPoint': {'lat': 25.11641, 'lon': 56.34141}}, {'zip': '12345', 'city': 'Sharjah city', 'country': 'United Arab Emirates', 'facility': 'Al Qassimi Hospital, Sharjah', 'geoPoint': {'lat': 25.3342, 'lon': 55.41221}}], 'overallOfficials': [{'name': 'Clinical Transparency (dept. 2834)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'ipdSharingStatementModule': {'url': 'https://novonordisk-trials.com', 'ipdSharing': 'YES', 'description': 'According to the Novo Nordisk disclosure commitment on novonordisk-trials.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}