Ignite Creation Date:
2025-12-25 @ 2:56 AM
Ignite Modification Date:
2026-02-05 @ 10:15 AM
Study NCT ID:
NCT02820233
Status:
RECRUITING
Last Update Posted:
2025-04-03
First Post:
2016-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Studies of Neuregulin/ERBB Signaling in Human Heart
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': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Plasma, circulating monocytes, and cardiac tissue.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2029-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-31', 'studyFirstSubmitDate': '2016-06-27', 'studyFirstSubmitQcDate': '2016-06-29', 'lastUpdatePostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of highly proliferative clones isolated', 'timeFrame': 'up to 14 days from isolation'}], 'secondaryOutcomes': [{'measure': 'Flow cytometric ERBB receptor expression in highly proliferative clones isolated from heart tissue', 'timeFrame': 'up to 14 days from isolation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Heart Disease', 'Vascular Disease', 'Heart Failure']}, 'referencesModule': {'references': [{'pmid': '29291395', 'type': 'BACKGROUND', 'citation': 'Ryzhov S, Robich MP, Roberts DJ, Favreau-Lessard AJ, Peterson SM, Jachimowicz E, Rath R, Vary CPH, Quinn R, Kramer RS, Sawyer DB. ErbB2 promotes endothelial phenotype of human left ventricular epicardial highly proliferative cells (eHiPC). J Mol Cell Cardiol. 2018 Feb;115:39-50. doi: 10.1016/j.yjmcc.2017.12.013. Epub 2017 Dec 29.'}, {'pmid': '32199337', 'type': 'BACKGROUND', 'citation': 'Robich M, Ryzhov S, Kacer D, Palmeri M, Peterson SM, Quinn RD, Carter D, Sheppard F, Hayes T, Sawyer DB, Rappold J, Prudovsky I, Kramer RS. Prolonged Cardiopulmonary Bypass is Associated With Endothelial Glycocalyx Degradation. J Surg Res. 2020 Jul;251:287-295. doi: 10.1016/j.jss.2020.02.011. Epub 2020 Apr 30.'}, {'pmid': '35609807', 'type': 'BACKGROUND', 'citation': 'de Kay JT, Carver J, Shevenell B, Kosta AM, Tsibulnikov S, Certo E, Sawyer DB, Ryzhov S, Robich MP. Decreased expression of ErbB2 on left ventricular epicardial cells in patients with diabetes mellitus. Cell Signal. 2022 Aug;96:110360. doi: 10.1016/j.cellsig.2022.110360. Epub 2022 May 21.'}]}, 'descriptionModule': {'briefSummary': 'This study examines the role of the epidermal growth factor (EGF) receptor family and the EGF family of ligands in the regulation of non-myocytes isolated from the human heart.', 'detailedDescription': 'The EGF family of receptor tyrosine kinases (a.k.a. ERBB receptors) mediate the effects of the epidermal growth factor (EGF) family including Neuregulin-1β (NRG). NRG and ERBB1-4 are critical for cardiac development and maintenance of the adult heart. Current understanding of the role of EGF/NRG/ERBB signaling in the cardiovascular system is rapidly evolving due to recent findings in non-myocyte cell populations. This study is examining a population of progenitor cells in the adult human heart that responds to EGF and NRG. Subjects are enrolled who are scheduled to undergo heart surgery and are willing to allow for a small biopsy to be taken from their hearts during surgery. Biopsies are taken to the laboratory where cells are separated and analyzed by flow cytometry and grown in cell culture to understand how their biology is regulated by NRG and EGF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with coronary artery disease with scheduled coronary artery bypass surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of severe coronary artery disease scheduled to undergo coronary artery bypass surgery.\n\nExclusion Criteria:\n\n* less than 18 years of age\n* unwilling or unable to provide informed consent\n* known active myocarditis\n* hypertrophic cardiomyopathy\n* constrictive pericarditis or other significant pericardial disease\n* severe pulmonary hypertension\n* significant renal impairment (Cr \\> 2.5 mg/dL)\n* severe ventricular arrhythmias\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT02820233', 'briefTitle': 'Studies of Neuregulin/ERBB Signaling in Human Heart', 'organization': {'class': 'OTHER', 'fullName': 'MaineHealth'}, 'officialTitle': 'Isolation and Characterization of ERBB Expressing Human Heart Progenitor Cells', 'orgStudyIdInfo': {'id': '4590'}}, 'contactsLocationsModule': {'locations': [{'zip': '04102', 'city': 'Portland', 'state': 'Maine', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joanne Burgess, RN', 'role': 'CONTACT', 'email': 'BURGEJS@mmc.org', 'phone': '207-662-2414'}], 'facility': 'Maine Medical Center', 'geoPoint': {'lat': 43.65737, 'lon': -70.2589}}], 'centralContacts': [{'name': 'Joanne Burgess, RN', 'role': 'CONTACT', 'email': 'burgejs@mmc.org'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Douglas B. Sawyer', 'class': 'OTHER'}, 'collaborators': [{'name': 'MaineHealth', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chief Academic Officer', 'investigatorFullName': 'Douglas B. Sawyer', 'investigatorAffiliation': 'MaineHealth'}}}}