Ignite Creation Date:
2025-12-24 @ 10:03 PM
Ignite Modification Date:
2025-12-30 @ 12:46 PM
Study NCT ID:
NCT03071835
Status:
COMPLETED
Last Update Posted:
2023-10-18
First Post:
2017-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparative Study of Subjects Past Their Final Follow-ON Visit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Genetic testing will consist of collecting tissue and/or blood stored for future use.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-17', 'studyFirstSubmitDate': '2017-02-13', 'studyFirstSubmitQcDate': '2017-03-01', 'lastUpdatePostDateStruct': {'date': '2023-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Continued Improvement in subject's symptoms", 'timeFrame': 'at 3, 5, 7, 9, and 13 Years', 'description': "Demonstrate change of subject's symptoms by assessing cardiac events over an extended period of time following participation in an ISCI cardiac trial where the subject received Investigational product."}], 'secondaryOutcomes': [{'measure': 'Change in Cardiac Function via Cardiac MRI', 'timeFrame': 'at 3, 5, 7, 9, and 13 Years', 'description': 'Evaluate Cardiac Function for changes, positive and negative via Cardiac MRI'}, {'measure': 'Change in Cardiac Function via Cardiac CT', 'timeFrame': 'at 3, 5, 7, 9, and 13 Years', 'description': 'Evaluate Cardiac Function for changes, positive and negative via Cardiac CT'}, {'measure': 'Evaluate Functional Capacity via the NYHA Class', 'timeFrame': 'at 3, 5, 7, 9, and 13 Years', 'description': 'Evaluate Functional Capacity via New York Heart Association (NYHA) Class Determination'}, {'measure': 'Evaluate Functional Capacity via the Six Minute Walk Test', 'timeFrame': 'at 3, 5, 7, 9, and 13 Years', 'description': 'Evaluate Functional Capacity via the Six Minute Walk Test'}, {'measure': 'Evaluate change in Quality of Life via the Minnesota Living with Heart Failure', 'timeFrame': 'at 3, 5, 7, 9, and 13 Years', 'description': 'Evaluate Quality Of Life Changes via Minnesota Living with Heart Failure (MLHF) Questionnaire'}, {'measure': 'Evaluate change in Symptoms via cardiac events', 'timeFrame': 'at 3, 5, 7, 9, and 13 Years', 'description': 'Evaluate Progression or Regression of disease (i.e. death, Left Ventricular Assist Device (LVAD), heart transplant and/or continuous intravenous infusion therapy (dobutamine, Milrinone, etc)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stem Cells', 'Cardiovascular', 'Quality of Life', 'Cardiomyopathy'], 'conditions': ['Cardiomyopathies', 'Heart Diseases', 'Aging Frailty']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://isci.med.miami.edu', 'label': 'Interdisciplinary Stem Cell Institute at the University of Miami Miller School of Medicine'}]}, 'descriptionModule': {'briefSummary': 'A comparative study to follow subjects who received stem cell therapies three, five, seven, nine, and thirteen years after their follow-on visit. Subjects will be selected from a pool of previous Interdisciplinary Stem Cell Institute trial participants.', 'detailedDescription': "A comparative study to follow subjects who received stem cell therapies three, five, seven, nine, and thirteen years after their follow-on visit. Subjects will be selected from a pool of previous Interdisciplinary Stem Cell Institute trial participants.\n\nSubjects will be followed during the study depending on the initial visit for this trial. The time point at which they are followed will depend on the subject's injection date in the previous trial. Depending on the subjects first treatment date (Day of injection) in the previous Interdisciplinary Stem Cell Institute (ISCI) cardiovascular clinical trial, subjects may be eligible for one to four study visits in this trial. Those who do not have a three, five, seven, nine or eleven year visit may receive informed consent at the year thirteen visit. Thus, subjects can be enrolled and consented at any visit if the previous eligible visit was missed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The population for this study will consist of subjects who previously participated at an ISCI Trial and who are able to consent to being followed past their Follow-On visit.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be 18 years of age and older\n* Provide written informed consent\n* Have been previously enrolled or currently participating in an investigator-initiated cardiovascular trial at ISCI (In cases where participants are currently enrolled in another clinical trial they are still able to participate concurrently in this trial).\n\nExclusion Criteria:\n\n* Have known, serious radiographic contrast allergy, which cannot be managed with premedication only if able to undergo MRI or CT.\n* Have a history of drug or alcohol abuse within the past 24 months'}, 'identificationModule': {'nctId': 'NCT03071835', 'acronym': 'HYPERION', 'briefTitle': 'A Comparative Study of Subjects Past Their Final Follow-ON Visit', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'A Comparative Study of Subjects tHree to Thirteen Years Past thEiR fInal Follow-ON Visit. (Hyperion Study)', 'orgStudyIdInfo': {'id': '20150899'}}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'ISCI / University of Miami Miller School of Medicine', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Joshua M Hare, Md', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Louis Lemberg Professor of Medicine Director, Interdisciplinary Stem Cell Institute', 'investigatorFullName': 'Joshua M Hare', 'investigatorAffiliation': 'University of Miami'}}}}