Ignite Creation Date:
2025-12-24 @ 10:12 PM
Ignite Modification Date:
2026-01-27 @ 9:09 PM
Study NCT ID:
NCT02831335
Status:
RECRUITING
Last Update Posted:
2025-10-15
First Post:
2016-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Technical Development of Multi-Parametric Renocerebral MRI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2032-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-13', 'studyFirstSubmitDate': '2016-06-15', 'studyFirstSubmitQcDate': '2016-07-08', 'lastUpdatePostDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MRI measured perfusion for each group', 'timeFrame': 'Baseline', 'description': 'MRI measurements will be summarized for each group by using mean and standard deviation or standard error.'}, {'measure': 'MRI measured vascular reactivity for each group', 'timeFrame': 'Baseline', 'description': 'MRI measurements will be summarized for each group by using mean and standard deviation or standard error.'}, {'measure': 'Cognitive performance for each group', 'timeFrame': 'Baseline', 'description': 'The total cognitive performance scores will be summarized for each group by using mean and standard deviation or standard error.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aging']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to investigate the associations of the age-related changes in the brain, kidneys and cognitive performance in healthy adults by utilizing multiple anatomic and functional MRI methods along with a battery of cognitive tests.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Normal participants will be recruited for four age groups with the following age ranges: 21 - 35, 36 -50, 51 - 65 and 66 - 80 years. For each subject group, equal number of male and female subjects will be recruited.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. English-speaking as primary language\n2. No hearing loss or uncorrected vision\n\nExclusion Criteria:\n\n1. Lacking capacity to consent\n2. Having known history of cardiovascular diseases (e.g., clinical stroke)\n3. Having acute and chronic obstructive pulmonary disease\n4. Having known history of renal diseases (e.g., acute kidney injury)\n5. Having known history of cognitive disorder or psychiatric illness\n6. Having known history of chemical dependence (e.g., alcohol and narcotics)\n7. Being treated with stimulant medications, anticonvulsants, antihypertensives or ß-adrenergic blockers'}, 'identificationModule': {'nctId': 'NCT02831335', 'briefTitle': 'Technical Development of Multi-Parametric Renocerebral MRI', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Technical Development of Multi-Parametric Renocerebral MRI', 'orgStudyIdInfo': {'id': '1603M85492'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'normal 21-35 years old participants', 'interventionNames': ['Other: MRI']}, {'label': 'Group 2', 'description': 'normal 36-50 years old participants', 'interventionNames': ['Other: MRI']}, {'label': 'Group 3', 'description': 'normal 51-65 years old participants', 'interventionNames': ['Other: MRI']}, {'label': 'Group 4', 'description': 'normal 66- 80 years old participants', 'interventionNames': ['Other: Group 4']}], 'interventions': [{'name': 'MRI', 'type': 'OTHER', 'description': 'Perform MRI studies', 'armGroupLabels': ['Group 1']}, {'name': 'MRI', 'type': 'OTHER', 'description': 'Perform MRI studies', 'armGroupLabels': ['Group 2']}, {'name': 'MRI', 'type': 'OTHER', 'description': 'Perform MRI studies', 'armGroupLabels': ['Group 3']}, {'name': 'Group 4', 'type': 'OTHER', 'description': 'Perform MRI studies', 'armGroupLabels': ['Group 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Xiufeng Li, PhD', 'role': 'CONTACT', 'email': 'lixx1607@umn.edu', 'phone': '612-625-8258'}], 'facility': 'Center for Magnetic Resonance Research', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'centralContacts': [{'name': 'Xiufeng Li, Ph.D.', 'role': 'CONTACT', 'email': 'lixx1607@umn.edu', 'phone': '6126258258'}], 'overallOfficials': [{'name': 'Xiufeng Li, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}