Ignite Creation Date:
2024-05-06 @ 3:40 AM
Last Modification Date:
2024-10-26 @ 11:37 AM
Study NCT ID:
NCT02348515
Status:
COMPLETED
Last Update Posted:
2018-11-27
First Post:
2015-01-22
Brief Title:
Cardiovascular Disease Protection Tissue
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Effects of ACE2Ang-1-7 on Cardiac Progenitor Cells From Heart Failure Patients and Explant Control
Status:
COMPLETED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Recent evidence of a potential role for cardiac progenitor cells CPCs in cardiac repair and the discovery of a vasoprotective axis of the renin-angiotensin system RAS offer such breakthroughs Investigators have observed that an imbalance in the vasoprotective axis angiotensin converting enzyme 2 ACE2angiotensin-1-7 Ang-1-7Mas receptor and the vasodeleterious axis angiotensin converting enzyme ACEangiotensin II AngIIAngII type 1 receptor AT1R of the RAS within the CPCs affects their functionality and regenerative potential Investigators believe that restoring the balance between these two axes of the RAS is essential to improve CPC function and enhance their reparative capabilities These observations have led to the hypothesis that genetic modification of CPCs by overexpression of ACE2Ang-1-7 will enhance their reparative function and improve their potential to attenuate myocardial ischemia-induced cardiac damage
Detailed Description:
As a participant undergoes a clinically indicated heart transplant or a left ventricular assist device LVAD implantation or a right heart biopsy or atrial fibrillation surgery or right atria cannulation the following tissue samples will be collected
In the subjects undergoing orthotopic heart transplant n20 failed myocardial tissue samples will be collected from the diseased heart
For subjects undergoing left ventricular assist device implantation n60 small samples will be collected from the apex core that would be routinely discarded at the time of the implantation procedure
For heart transplant subjects undergoing clinically indicated right heart biopsy n20 the collection of multiple samples including excess myocardial biopsy samples that will not be utilized by pathology
For subjects undergoing any heart surgery n80 the collection of left atrial appendages that are routinely removed to prevent thrombosis during atrial fibrillation surgery and a piece of the right atria will be cut in order to implant the cannula
In addition a collection of 20ml about one tablespoon of blood will be taken from all subjects to analyze progenitorinflammatory cells and inflammation cytokines and pertinent medical history
In the subjects undergoing orthotopic heart transplant n20 failed myocardial tissue samples will be collected from the diseased heart
For subjects undergoing left ventricular assist device implantation n60 small samples will be collected from the apex core that would be routinely discarded at the time of the implantation procedure
For heart transplant subjects undergoing clinically indicated right heart biopsy n20 the collection of multiple samples including excess myocardial biopsy samples that will not be utilized by pathology
For subjects undergoing any heart surgery n80 the collection of left atrial appendages that are routinely removed to prevent thrombosis during atrial fibrillation surgery and a piece of the right atria will be cut in order to implant the cannula
In addition a collection of 20ml about one tablespoon of blood will be taken from all subjects to analyze progenitorinflammatory cells and inflammation cytokines and pertinent medical history
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL056921 | NIH | None | httpsreporternihgovquickSearchR01HL056921 |