Studies of Neuregulin/ERBB Signaling in Human Heart
Isolation and Characterization of ERBB Expressing Human Heart Progenitor Cells
1 other identifier
observational
80
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 27, 2016
CompletedFirst Posted
Study publicly available on registry
June 30, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2029
April 3, 2025
July 1, 2024
13.3 years
June 27, 2016
March 31, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
The number of highly proliferative clones isolated
up to 14 days from isolation
Secondary Outcomes (1)
Flow cytometric ERBB receptor expression in highly proliferative clones isolated from heart tissue
up to 14 days from isolation
Eligibility Criteria
Subjects with coronary artery disease with scheduled coronary artery bypass surgery.
You may qualify if:
- Clinical diagnosis of severe coronary artery disease scheduled to undergo coronary artery bypass surgery.
You may not qualify if:
- less than 18 years of age
- unwilling or unable to provide informed consent
- known active myocarditis
- hypertrophic cardiomyopathy
- constrictive pericarditis or other significant pericardial disease
- severe pulmonary hypertension
- significant renal impairment (Cr \> 2.5 mg/dL)
- severe ventricular arrhythmias
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Douglas B. Sawyerlead
- MaineHealthcollaborator
Study Sites (1)
Maine Medical Center
Portland, Maine, 04102, United States
Related Publications (3)
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: 29291395BACKGROUNDRobich 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: 32199337BACKGROUNDde 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.
PMID: 35609807BACKGROUND
Biospecimen
Plasma, circulating monocytes, and cardiac tissue.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Chief Academic Officer
Study Record Dates
First Submitted
June 27, 2016
First Posted
June 30, 2016
Study Start
June 1, 2015
Primary Completion (Estimated)
September 1, 2028
Study Completion (Estimated)
June 1, 2029
Last Updated
April 3, 2025
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will share