Cardiovascular Disease Protection Tissue

University of Florida

Status: Completed

Conditions: Myocardial Ischemia

Treatments: Procedure: Blood Draw; Procedure: Heart failure or coronary disease; Procedure: Heart Surgery Patients; Procedure: Orthotopic Heart Transplant Patients; Procedure: Heart transplant patients

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT02348515

R01HL056921 (U.S. NIH Grant/Contract)

IRB201300122-N

Details and patient eligibility

About

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 (ACE2)/angiotensin-(1-7) [Ang-(1-7)]/Mas receptor} and the vasodeleterious axis [angiotensin converting enzyme (ACE)/angiotensin II (AngII)/AngII 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 ACE2/Ang-(1-7) will enhance their reparative function and improve their potential to attenuate myocardial ischemia-induced cardiac damage.

Full 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 (n=20), failed myocardial tissue samples will be collected from the diseased heart.

For subjects undergoing left ventricular assist device implantation (n=60), 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 (n=20), the collection of multiple samples including, excess myocardial biopsy samples that will not be utilized by pathology.

For subjects undergoing any heart surgery (n=80), 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 progenitor/inflammatory cells and inflammation cytokines and pertinent medical history.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• heart transplant surgery
• left ventricular assist device implantation
• heart surgery required for atrial fibrillation and right atria cannulation

Exclusion criteria

• We are collecting discarded tissues following surgery. There is no exclusion criteria for this study.

Trial design

8 participants in 4 patient groups

Heart failure or coronary disease

Description:

This group will have small samples collected from the apex core (that would be routinely discarded at the time of the implantation procedure) by undergoing a left ventricular assist device implantation. In addition, a blood sample will be collected.

Treatment:

Procedure: Heart failure or coronary disease

Procedure: Blood Draw

Heart transplant patients

Description:

This group will have multiple samples collected including, excess myocardial biopsy samples that will not be utilized by pathology. In addition, a blood sample will be collected.

Treatment:

Procedure: Heart transplant patients

Procedure: Blood Draw

Orthotopic Heart Transplant Patients

Description:

This group will have myocardial tissue samples collected from the diseased heart. In addition, a blood sample will be taken.

Treatment:

Procedure: Blood Draw

Procedure: Orthotopic Heart Transplant Patients

Heart Surgery Patients

Description:

This groups will have samples collected from the 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 blood sample will be taken.

Treatment:

Procedure: Heart Surgery Patients

Procedure: Blood Draw