Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2026-01-20 @ 5:47 PM
Study NCT ID:
NCT05597657
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2022-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Normal Variation of T1 Values With Cardiac Magnetic Resonance in Healthy Individuals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-15', 'studyFirstSubmitDate': '2022-05-25', 'studyFirstSubmitQcDate': '2022-10-24', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in T1 values (substudy 1)', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Change in T1 values between two consecutive scans on the same day'}, {'measure': 'Change of T1 values (substudy 2)', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Change in T1 values after fluid administration'}, {'measure': 'Change in T1 values (substudy 3)', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Change in T1 values over time (baseline, 6 months, 1 year)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Magnetic Resonance', 'T1 Mapping', 'Healthy Individuals']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine the normal variation of T1 values with cardiac magnetic resonance in healthy individuals with respect to reproducibility, changes over time, and dependency on hydration status.', 'detailedDescription': 'T1 mapping with cardiac magnetic resonance (CMR) is a novel non-invasive technique to quantitatively characterize the myocardium. T1 mapping is a surrogate marker of myocardial edema and fibrosis, and has the potential to be implemented in the diagnosis and follow-up of various cardiac diseases. However, there is limited data on the natural variation of T1 mapping in healthy individuals.\n\nThe study comprises three substudies:\n\n1. Reproducibility: Two identical CMR examinations with T1 mapping will be performed on the same day .\n2. Hydration changes: Participants will receive two liters of isotonic saline intravenously between two identical CMR with T1 mapping and echocardiographic examinations. The post-fluid order of CMR and echocardiography will be randomized.\n3. Time changes: Participants will undergo CMR with T1 mapping at baseline, at 6-months follow-up, and at 1-year follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-89 years\n* Healthy\n\nExclusion Criteria:\n\n* Chronic disease (e.g. cardiovascular disease, rheumatological disease, lung disease)\n* Medications affecting the cardiovascular system (e.g. antihypertensives, statins, anticoagulants)\n* Contraindications for CMR (claustrophobia, pregnancy, magnetic metallic implants)'}, 'identificationModule': {'nctId': 'NCT05597657', 'acronym': 'NATIVE', 'briefTitle': 'Normal Variation of T1 Values With Cardiac Magnetic Resonance in Healthy Individuals', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Normal Variation of T1 Values With Cardiac Magnetic Resonance in Healthy Individuals', 'orgStudyIdInfo': {'id': 'H-21025256'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Fluid administration (substudy 2)', 'interventionNames': ['Other: Fluid administration (Fresenius Kabi Sodium Chloride 0.9%)']}], 'interventions': [{'name': 'Fluid administration (Fresenius Kabi Sodium Chloride 0.9%)', 'type': 'OTHER', 'description': 'All participants in substudy 2 will be administered 2 liters of isotonic saline infusion (Fresenius Kabi Sodium Chloride 0.9%) intravenously. CMR and echocardiography will be performed before and after infusion.', 'armGroupLabels': ['Fluid administration (substudy 2)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Katrine A Myhr, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'ipdSharingStatementModule': {'timeFrame': 'From study end', 'ipdSharing': 'YES', 'description': 'Data can be provided upon request', 'accessCriteria': 'Researchers who provide a methodological sound proposal'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Danish Cardiovascular Academy (DCA)', 'class': 'UNKNOWN'}, {'name': 'Eva og Henry Frænkels Mindefond', 'class': 'OTHER'}, {'name': 'Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principital Investigator', 'investigatorFullName': 'Katrine Aagaard Myhr', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}