Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT05603520
Status:
RECRUITING
Last Update Posted:
2024-01-10
First Post:
2022-10-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phenotyping Heterogeneity and Regionality of the Aorta
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001018', 'term': 'Aortic Diseases'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D001014', 'term': 'Aortic Aneurysm'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}, {'id': 'D000783', 'term': 'Aneurysm'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'prospectively defined blood sampling protocol'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-09', 'studyFirstSubmitDate': '2022-10-24', 'studyFirstSubmitQcDate': '2022-10-28', 'lastUpdatePostDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progressive accelerated Large Artery Stiffening', 'timeFrame': '5 years', 'description': 'measured by CMR'}, {'measure': 'Development of Aortic Aneurysm', 'timeFrame': '5 years', 'description': 'measured by CMR'}, {'measure': 'Progressive accelerated Large Artery Stiffening', 'timeFrame': '5 years', 'description': 'measured by tonometry'}], 'secondaryOutcomes': [{'measure': 'Diastolic Dysfunction', 'timeFrame': '5 years', 'description': 'measured by CMR'}, {'measure': 'Diastolic Dysfunction', 'timeFrame': '5 years', 'description': 'measured by echocardiography'}, {'measure': 'Ejection Rate and Ejection Time', 'timeFrame': '5 years', 'description': 'measured by CMR'}, {'measure': 'Ejection Rate and Ejection Time', 'timeFrame': '5 years', 'description': 'measured by echocardiography'}, {'measure': 'Flow encoded regional MRI metrics', 'timeFrame': '5 years', 'description': 'measured by CMR'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['aortic disease', 'large artery stiffness', 'aortic stenosis', 'aortic aneurysm'], 'conditions': ['Large Artery Stiffness', 'Aortic Disease', 'Aortic Stenosis', 'Aortic Aneurysm']}, 'referencesModule': {'references': [{'pmid': '38836358', 'type': 'DERIVED', 'citation': 'Quast C, Bonner F, Polzin A, Veulemans V, Chennupati R, Gyamfi Poku I, Pfeiler S, Kramser N, Nankinova M, Staub N, Zweck E, Jokiel J, Keyser F, Hoffe J, Witkowski S, Becker K, Leuders P, Zako S, Erkens R, Jung C, Flogel U, Wang T, Neidlin M, Steinseifer U, Niepmann ST, Zimmer S, Gerdes N, Cortese-Krott MM, Feelisch M, Zeus T, Kelm M. Aortic Valve Stenosis Causes Accumulation of Extracellular Hemoglobin and Systemic Endothelial Dysfunction. Circulation. 2024 Sep 17;150(12):952-965. doi: 10.1161/CIRCULATIONAHA.123.064747. Epub 2024 Jun 5.'}]}, 'descriptionModule': {'briefSummary': 'The aorta distributes cardiac stroke volume into the whole body through its finetuned conductance function, that is propagation and modulation of flow pattern. Physicomechanic properties of the aortic wall assure continuous and homogenous blood flow distribution to organs. The physicomechanic properties of the aortic wall are heterotopic: The collagen/elastin ratio doubles in the abdominal aorta as compared to the thoracic aorta. Malfunction of aortic conduction due to large artery stiffening (LAS) leads to premature wave reflection and excess pulsatility which translate into organ damage in low-resistance beds. The regional heterogeneity of aortic physicomechanic properties and their histomorphological substrate leading to altered regional hemodynamics are not well investigated.\n\nWithin the PHaRAo population, there is a spectrum of higher and lower risk patients. The aim of this cohort study is to collect prospectively and systematically clinical research data from PHaRAo patients. This cohort study is an open-end observational study to identify master switches in aortic disease'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'healthy volunteers, patients with aortic stenosis, patients with aortic aneurysm', 'healthyVolunteers': True, 'eligibilityCriteria': '1. apparently healthy volunteers\n\n Inclusion Criteria:\n\n • Healthy volunteers\n\n Exclusion Criteria:\n * \\< 18 years\n * Active Medication\n * Cardiovascular Disease\n * MRI not possible\n2. Patients with Aortic Stenosis\n\n Inclusion Criteria:\n\n • Patients suffering from 3rd drgree Aortic Stenosis\n\n Exclusion Criteria:\n * \\< 18 years\n * MRI not possible\n3. Patients with Aortic Aneurysms\n\nInclusion Criteria:\n\n• Patients suffering from Aortic Aneurysms\n\nExclusion Criteria:\n\n* \\< 18 years\n* MRI not possible'}, 'identificationModule': {'nctId': 'NCT05603520', 'acronym': 'PHaRAo', 'briefTitle': 'Phenotyping Heterogeneity and Regionality of the Aorta', 'organization': {'class': 'OTHER', 'fullName': 'Heinrich-Heine University, Duesseldorf'}, 'officialTitle': 'Phenotyping Heterogeneity and Regionality of the Aorta', 'orgStudyIdInfo': {'id': 'PHaRAo'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'healthy volunteers', 'interventionNames': ['Other: Collection of Clinical Data']}, {'label': 'patients with aortic stenosis', 'interventionNames': ['Other: Collection of Clinical Data']}, {'label': 'patients with aortic aneurysms', 'interventionNames': ['Other: Collection of Clinical Data']}], 'interventions': [{'name': 'Collection of Clinical Data', 'type': 'OTHER', 'description': 'prospectively and systematically collection of clinical research data from apparently healthy volunteers and patients with aortic stenosis and aneurysms', 'armGroupLabels': ['healthy volunteers', 'patients with aortic aneurysms', 'patients with aortic stenosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40225', 'city': 'Düsseldorf', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Christine Quast, MD', 'role': 'CONTACT', 'email': 'Christine.Quast@med.uni-duesseldorf.de'}, {'name': 'Christine Quast, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Malte Kelm, Prof, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Josephin Cebulla', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Pia Leuders, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Magdalena Nankinova', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Christine Quast', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}], 'centralContacts': [{'name': 'Christine Quast, MD', 'role': 'CONTACT', 'email': 'Christine.Quast@med.uni-duesseldorf.de', 'phone': '+492118118800'}, {'name': 'Lisa Dannenberg, MD', 'role': 'CONTACT', 'email': 'LisaKristina.Dannenberg@med.uni-duesseldorf.de', 'phone': '+49211 81 05315'}], 'overallOfficials': [{'name': 'Malte Kelm, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Division of Cardiology, Pulmonary Disease and Vascular Medicine'}, {'name': 'Christine Quast, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Cardiology, Pulmonary Disease and Vascular Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heinrich-Heine University, Duesseldorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}