Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:47 AM
Study NCT ID:
NCT06976502
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-06-06
First Post:
2025-05-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Health eHeart BioBank
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D014015', 'term': 'Tissue Banks'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D018070', 'term': 'Biological Specimen Banks'}, {'id': 'D006268', 'term': 'Health Facilities'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples with be collected with the option of DNA, heart tissue, and other samples may be collected.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500000}, 'targetDuration': '20 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2035-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-05', 'studyFirstSubmitDate': '2025-05-08', 'studyFirstSubmitQcDate': '2025-05-08', 'lastUpdatePostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2035-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Establish and Maintain a Centralized Biorepository', 'timeFrame': 'Up to 10 years', 'description': 'Establish and maintain a centralized biorepository to collect and store a variety of biospecimen samples and clinical data.\n\nThis would allow for the samples and clinical data to be used to test hypotheses regarding the molecular and genetic basis of diagnosis and treatment of cardiovascular diseases.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heart Disease', 'Cardiovascular Disease', 'Cardiology'], 'conditions': ['Heart Diseases', 'Cardiac Diseases', 'Vascular Diseases', 'Cardiovascular Diseases']}, 'referencesModule': {'references': [{'pmid': '23612580', 'type': 'BACKGROUND', 'citation': 'Rahmutula D, Marcus GM, Wilson EE, Ding CH, Xiao Y, Paquet AC, Barbeau R, Barczak AJ, Erle DJ, Olgin JE. Molecular basis of selective atrial fibrosis due to overexpression of transforming growth factor-beta1. Cardiovasc Res. 2013 Sep 1;99(4):769-79. doi: 10.1093/cvr/cvt074. Epub 2013 Apr 23.'}, {'pmid': '29915095', 'type': 'BACKGROUND', 'citation': 'Tseng ZH, Olgin JE, Vittinghoff E, Ursell PC, Kim AS, Sporer K, Yeh C, Colburn B, Clark NM, Khan R, Hart AP, Moffatt E. Prospective Countywide Surveillance and Autopsy Characterization of Sudden Cardiac Death: POST SCD Study. Circulation. 2018 Jun 19;137(25):2689-2700. doi: 10.1161/CIRCULATIONAHA.117.033427.'}, {'pmid': '21658281', 'type': 'BACKGROUND', 'citation': 'Aouizerat BE, Vittinghoff E, Musone SL, Pawlikowska L, Kwok PY, Olgin JE, Tseng ZH. GWAS for discovery and replication of genetic loci associated with sudden cardiac arrest in patients with coronary artery disease. BMC Cardiovasc Disord. 2011 Jun 10;11:29. doi: 10.1186/1471-2261-11-29.'}, {'pmid': '24237655', 'type': 'BACKGROUND', 'citation': 'Roberts JD, Hsu JC, Aouizerat BE, Pullinger CR, Malloy MJ, Kane JP, Olgin JE, Marcus GM. Impact of a 4q25 genetic variant in atrial flutter and on the risk of atrial fibrillation after cavotricuspid isthmus ablation. J Cardiovasc Electrophysiol. 2014 Mar;25(3):271-277. doi: 10.1111/jce.12317. Epub 2013 Dec 13.'}, {'pmid': '27179719', 'type': 'BACKGROUND', 'citation': 'Roberts JD, Dewland TA, Glidden DV, Hoffmann TJ, Arking DE, Chen LY, Psaty BM, Olgin JE, Alonso A, Heckbert SR, Marcus GM. Impact of genetic variants on the upstream efficacy of renin-angiotensin system inhibitors for the prevention of atrial fibrillation. Am Heart J. 2016 May;175:9-17. doi: 10.1016/j.ahj.2016.02.002. Epub 2016 Feb 13.'}, {'pmid': '25381796', 'type': 'BACKGROUND', 'citation': 'Roberts JD, Dewland TA, Longoria J, Fitzpatrick AL, Ziv E, Hu D, Lin J, Glidden DV, Psaty BM, Burchard EG, Blackburn EH, Olgin JE, Heckbert SR, Marcus GM. Telomere length and the risk of atrial fibrillation: insights into the role of biological versus chronological aging. Circ Arrhythm Electrophysiol. 2014 Dec;7(6):1026-32. doi: 10.1161/CIRCEP.114.001781. Epub 2014 Nov 8.'}, {'pmid': '18242542', 'type': 'BACKGROUND', 'citation': 'Marcus GM, Smith LM, Glidden DV, Wilson E, McCabe JM, Whiteman D, Tseng ZH, Badhwar N, Lee BK, Lee RJ, Scheinman MM, Olgin JE. Markers of inflammation before and after curative ablation of atrial flutter. Heart Rhythm. 2008 Feb;5(2):215-21. doi: 10.1016/j.hrthm.2007.10.007. Epub 2007 Oct 7.'}, {'pmid': '25406240', 'type': 'BACKGROUND', 'citation': 'Roberts JD, Longoria J, Poon A, Gollob MH, Dewland TA, Kwok PY, Olgin JE, Deo RC, Marcus GM. Targeted deep sequencing reveals no definitive evidence for somatic mosaicism in atrial fibrillation. Circ Cardiovasc Genet. 2015 Feb;8(1):50-7. doi: 10.1161/CIRCGENETICS.114.000650. Epub 2014 Nov 18.'}, {'pmid': '36947466', 'type': 'BACKGROUND', 'citation': 'Marcus GM, Rosenthal DG, Nah G, Vittinghoff E, Fang C, Ogomori K, Joyce S, Yilmaz D, Yang V, Kessedjian T, Wilson E, Yang M, Chang K, Wall G, Olgin JE. Acute Effects of Coffee Consumption on Health among Ambulatory Adults. N Engl J Med. 2023 Mar 23;388(12):1092-1100. doi: 10.1056/NEJMoa2204737.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the Health eHeart BioBank is to collect and store specimen (e.g. blood, DNA, tissue) for future studies at the University of California, San Francisco (UCSF) that will help determine changes and identify molecular and genetic markers in the human body that might help increase our knowledge of heart disease and guide development of new diagnostic tools and treatments that may help rapidly detect heart disease and prevent and/or treat heart disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study population are patients of the University of California, San Francisco and their relatives.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years or older.\n\nAnd at least one of the following:\n\n* Established patient seen at UCSF and/or is a current participant in a clinical study that utilizes the HeH BioBank for biospecimen collection.\n* Family member of a patient with cardiovascular disease.\n* Patient with no cardiovascular disease.\n\nExclusion Criteria:\n\n* Unwilling to consent to biospecimen collection through the HeH BioBank.'}, 'identificationModule': {'nctId': 'NCT06976502', 'acronym': 'HeH BioBank', 'briefTitle': 'Health eHeart BioBank', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Health eHeart BioBank', 'orgStudyIdInfo': {'id': '24-40979'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants with a History of Cardiovascular Disease', 'interventionNames': ['Procedure: Blood Draw', 'Procedure: Tissue Collection', 'Procedure: DNA Collection', 'Other: Medical Chart Review']}, {'label': 'Participants with a Family History of Cardiovascular Disease', 'interventionNames': ['Procedure: Blood Draw', 'Procedure: Tissue Collection', 'Procedure: DNA Collection', 'Other: Medical Chart Review']}, {'label': 'Healthy Controls', 'interventionNames': ['Procedure: Blood Draw', 'Procedure: Tissue Collection', 'Procedure: DNA Collection', 'Other: Medical Chart Review']}], 'interventions': [{'name': 'Blood Draw', 'type': 'PROCEDURE', 'description': 'Participants will be asked to contribute approximately 36 mL of blood using standard procedures and obtained at the time of a clinically ordered routine blood draw or a study ordered blood draw. Participants may be asked to contribute additional blood samples over the course of their participation in the study.', 'armGroupLabels': ['Healthy Controls', 'Participants with a Family History of Cardiovascular Disease', 'Participants with a History of Cardiovascular Disease']}, {'name': 'Tissue Collection', 'type': 'PROCEDURE', 'description': 'If the participant is undergoing a clinically ordered procedure (e.g. heart surgery/biopsy/transplant), then they will be asked to contribute tissue to the study before any tissue is collected during the procedure. Most samples collected by the HeH BioBank will be tissue that would be normally discarded after the procedure.', 'armGroupLabels': ['Healthy Controls', 'Participants with a Family History of Cardiovascular Disease', 'Participants with a History of Cardiovascular Disease']}, {'name': 'DNA Collection', 'type': 'PROCEDURE', 'description': 'Participants will be asked to contribute their DNA for Whole Genome Sequencing (WGS) to help identify genetic markers of heart disease. DNA will be obtained at the time of the blood draw or obtained through DNA collection kits administered to participants who are unable or unwilling to undergo a blood draw.', 'armGroupLabels': ['Healthy Controls', 'Participants with a Family History of Cardiovascular Disease', 'Participants with a History of Cardiovascular Disease']}, {'name': 'Medical Chart Review', 'type': 'OTHER', 'otherNames': ['Medical Record Review'], 'description': "Demographic, clinical, and pathologic information will be extracted from the participant's medical record.", 'armGroupLabels': ['Healthy Controls', 'Participants with a Family History of Cardiovascular Disease', 'Participants with a History of Cardiovascular Disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Jeffrey E Olgin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}, {'name': 'Gregory Marcus, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}, {'name': 'Vasanth Vedantham, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}, {'name': "Connor G O'Brien, MD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}, {'name': 'James P Pirruccello, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}