Myocardial IschemiaNCT02348515
Cardiovascular Disease Protection Tissue
An observational study of Myocardial Ischemia, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Ischemia
- What is being tested?
- Heart failure or coronary disease, Heart transplant patients and Orthotopic Heart Transplant Patients
- Type of treatment
- Surgery or procedure
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to 28 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing orthotopic heart transplant, left ventricular assist device implantation, right heart biopsy, and any other heart surgery (atrial fibrillation and right atria cannulation).
Who may be able to join
- heart transplant surgery
- left ventricular assist device implantation
- heart surgery required for atrial fibrillation and right atria cannulation
Who cannot join
- We are collecting discarded tissues following surgery. There is no exclusion criteria for this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of ACE2/Ang-(1-7) on Cardiac Progenitor Cells From Heart Failure Patients and Explant Control
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.
Read the 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 (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.
- Conditions
- Myocardial Ischemia
- Being tested
- Heart failure or coronary disease, Heart transplant patients, Orthotopic Heart Transplant Patients, Heart Surgery Patients, Blood Draw
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart failure or coronary diseaseProcedure or surgery
Small samples collected from the apex core in the heart. In addition, blood samples will be taken.
Heart transplant patientsProcedure or surgery
Heart samples collected including, excess myocardial biopsy samples. In addition, blood samples will be taken.
Orthotopic Heart Transplant PatientsProcedure or surgery
Myocardial tissue samples collected from the diseased heart. In addition, blood samples will be taken.
Heart Surgery PatientsProcedure or surgery
Heart samples will be collected from the left atrial appendages. In addition, blood samples will be taken.
Blood DrawProcedure or surgery
All subjects will have 20 ml of blood drawn for further analysis.
| Study group | Role | What they receive |
|---|---|---|
| Heart failure or coronary disease | 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. Receives: Procedure: Heart failure or coronary disease; Procedure: Blood Draw | |
| Heart transplant patients | 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. Receives: Procedure: Heart transplant patients; Procedure: Blood Draw | |
| Orthotopic Heart Transplant Patients | This group will have myocardial tissue samples collected from the diseased heart. In addition, a blood sample will be taken. Receives: Procedure: Orthotopic Heart Transplant Patients; Procedure: Blood Draw | |
| Heart Surgery Patients | 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. Receives: Procedure: Heart Surgery Patients; Procedure: Blood Draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Imbalance of vasoprotective and vasodeleterious axes of the renin angiotensin system (RAS) is associated with dysfunction of CPC isolated from diseased tissue
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.
Measured: two years
Secondary outcomes (1)
Screening for biomarkers related to clinic outcome in the blood
Progenitor/inflammatory cells, inflammatory cytokines, and growth factors will be measured to determine if they are associated with heart diseases.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study startJun 2013
- Primary completion28 Sep 2018
- Study completion28 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial IschemiaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Carl J Pepine, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02348515
- Sponsor's protocol ID
- IRB201300122-N
- Other IDs
- R01HL056921
- Status last verified
- Nov 2018
- First submitted
- 22 Jan 2015
- Last updated
- 27 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of ACE2/Ang-(1-7) on Cardiac Progenitor Cells From Heart Failure Patients and Explant Control
- ClinicalTrials.gov ID
- NCT02348515
- Acronym / sponsor ID
- IRB201300122-N
- Conditions
- Myocardial Ischemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jun 2013
- Primary completion
- 28 Sep 2018 (actual)
- Study completion
- 28 Sep 2018 (actual)
- First posted
- 28 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Heart failure or coronary disease | – | Procedure: Heart failure or coronary disease, Procedure: Blood DrawThis 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. |
| Heart transplant patients | – | Procedure: Heart transplant patients, Procedure: Blood DrawThis 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. |
| Orthotopic Heart Transplant Patients | – | Procedure: Orthotopic Heart Transplant Patients, Procedure: Blood DrawThis group will have myocardial tissue samples collected from the diseased heart. In addition, a blood sample will be taken. |
| Heart Surgery Patients | – | Procedure: Heart Surgery Patients, Procedure: Blood DrawThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing orthotopic heart transplant, left ventricular assist device implantation, right heart biopsy, and any other heart surgery (atrial fibrillation and right atria cannulation).
Key inclusion criteria (3 listed)
- heart transplant surgery
- left ventricular assist device implantation
- heart surgery required for atrial fibrillation and right atria cannulation
Key exclusion criteria (1 listed)
- We are collecting discarded tissues following surgery. There is no exclusion criteria for this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart failure or coronary diseaseSmall samples collected from the apex core in the heart. In addition, blood samples will be taken. | Procedure or surgery | Heart failure or coronary disease |
| Heart transplant patientsHeart samples collected including, excess myocardial biopsy samples. In addition, blood samples will be taken. | Procedure or surgery | Heart transplant patients |
| Orthotopic Heart Transplant PatientsMyocardial tissue samples collected from the diseased heart. In addition, blood samples will be taken. | Procedure or surgery | Orthotopic Heart Transplant Patients |
| Heart Surgery PatientsHeart samples will be collected from the left atrial appendages. In addition, blood samples will be taken. | Procedure or surgery | Heart Surgery Patients |
| Blood DrawAll subjects will have 20 ml of blood drawn for further analysis. | Procedure or surgery | Heart Surgery Patients, Heart failure or coronary disease, Heart transplant patients, Orthotopic Heart Transplant Patients |
Primary outcome
Imbalance of vasoprotective and vasodeleterious axes of the renin angiotensin system (RAS) is associated with dysfunction of CPC isolated from diseased tissue
Time frame: two years
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.
1 secondary outcome
Screening for biomarkers related to clinic outcome in the blood
Time frame: two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carl J Pepine, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Ischemia, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Imbalance of vasoprotective and vasodeleterious axes of the renin angiotensin system (RAS) is associated with dysfunction of CPC isolated from diseased tissue (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2018; AzTrials last refreshed its copy on 4 Nov 2026.