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NCT02348515 · ClinicalTrials.gov registry record

Cardiovascular Disease Protection Tissue

A clinical trial, sponsored by University of Florida.

Completed
Registry status
8
Enrollment target

NCT02348515: Completed study, sponsored by University of Florida.

NCT02348515 is a clinical trial that has completed, run by University of Florida. The registered enrollment target is 8 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02348515 has completed, sponsored by University of Florida.

COMPLETED
Registry status
8 participants
Enrollment target

Study 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 (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.

Primary Outcome

CPCs will be isolated from the collected heart tissue. Function assay such as proliferation, migration, reactive oxygen species (ROS) level will be analyzed. Renin-angiotensin system (RAS) genes and inflammatory cytokines will be quantifies using polymerase chain reaction (PCR) and protein assay to investigate if the cell dysfunction is associated with the imbalance of vasoprotective and vasodeleterious axes of the RAS.

Interventions

  • PROCEDURE Blood Draw
  • PROCEDURE Heart failure or coronary disease
  • PROCEDURE Heart transplant patients
  • PROCEDURE Orthotopic Heart Transplant Patients
  • PROCEDURE Heart Surgery Patients

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2013-06
Est. Completion 2018-09-28
University of Florida

1,106 total trials

What the finished NCT02348515 record still lists

NCT02348515 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 8 participants, a relatively small participant target.

The record links to 0 conditions, and to 5 interventions - of which Blood Draw is the first listed.

NCT02348515 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02348515 about?

NCT02348515 is a clinical study titled "Cardiovascular Disease Protection Tissue". 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...

What is the current status of trial NCT02348515?

This trial is currently completed. The enrollment target is 8 participants. The study started on 2013-06. Estimated completion is 2018-09-28.

What interventions are being tested in trial NCT02348515?

The interventions under investigation include: Blood Draw (PROCEDURE), Heart failure or coronary disease (PROCEDURE), Heart transplant patients (PROCEDURE), Orthotopic Heart Transplant Patients (PROCEDURE), Heart Surgery Patients (PROCEDURE).

Who is sponsoring clinical trial NCT02348515?

This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT02348515, the US trial registry maintained by the National Library of Medicine. NCT02348515 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.