Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2026-04-14 @ 9:43 PM
Study NCT ID:
NCT05521503
Status:
RECRUITING
Last Update Posted:
2024-12-11
First Post:
2022-08-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biopsy Collection and Repository Database
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'During this study, tissue samples (blood, urine and/or myocardial tissue) will be used to help identify trends in biomarkers and other information for patients with Cardiac Amyloidosis and other Cardiovascular conditions. No clinically important information that could be used by the subject will be identified. Therefore, the results of these studies will not be shared with the subjects.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-05', 'studyFirstSubmitDate': '2022-08-20', 'studyFirstSubmitQcDate': '2022-08-25', 'lastUpdatePostDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Discover and quantify the concentration of novel diagnostic and prognostic biomarkers', 'timeFrame': '12/21/2021-12/31/2030', 'description': 'Use biospecimens procured from patients with cardiac conditions to identify diagnostic surrogate biomarkers using discovery proteomics. In Cardiac Amyloidosis, the serum levels will be compared between confirmed ATTR and non-ATTR heart failure patients and a diagnostic threshold will be established. The research aims to advance understanding of cardiac diseases and to support the development of improved therapies.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': 'Use samples procured from patients to improve understanding of molecular, cellular, and tissue-level processes produced by a variety of cardiac diseases and therapeutic interventions.', 'detailedDescription': 'This is a prospective study enrolling patients referred for or undergoing cardiovascular procedures or treatment at the University of Kentucky. The study aims to facilitate the discovery of novel diagnostic biomarkers and therapeutic targets and improve the pathophysiological understanding of cardiac conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients undergoing evaluation of a cardiac condition or receiving a right heart catheterization with biopsy clinically indicated who are at least 18 years of age.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients undergoing evaluation of a cardiac condition or receiving a right heart catheterization with biopsy clinically indicated who are at least 18 years of age.\n\nExclusion Criteria:\n\n* Patients without a cardiovascular or amyloidosis diagnosis, under 18 years of age.'}, 'identificationModule': {'nctId': 'NCT05521503', 'acronym': 'BICARD', 'briefTitle': 'Biopsy Collection and Repository Database', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'Cardiac Biopsy Collection Repository and Database', 'orgStudyIdInfo': {'id': '73647'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Biological specimens', 'description': 'Biological specimens taken from cardiovascular procedures'}]}, 'contactsLocationsModule': {'locations': [{'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Andrew Kolodziej, MD', 'role': 'CONTACT', 'email': 'andrew.kolodziej@uky.edu', 'phone': '(859) 562-0902'}, {'name': 'Jennifer Isaacs, MS, MS', 'role': 'CONTACT', 'email': 'jennifer.isaacs@uky.edu', 'phone': '(859) 323-4738'}, {'name': 'Andrew Kolodziej, MD', 'role': 'CONTACT'}], 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}], 'centralContacts': [{'name': 'Andrew R Kolodziej, MD', 'role': 'CONTACT', 'email': 'andrew.kolodziej@uky.edu', 'phone': '(859) 562-0902'}, {'name': 'Jennifer Isaacs, MS, MS', 'role': 'CONTACT', 'email': 'jennifer.isaacs@uky.edu', 'phone': '(859) 323-4738'}], 'overallOfficials': [{'name': 'Andrew R Kolodziej, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kentucky'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Andrew Kolodziej', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Andrew Kolodziej', 'investigatorAffiliation': 'University of Kentucky'}}}}