Coronary Artery DiseaseAGE-PCINCT00585949
Age and Endothelial Progenitor Cell Mobilization
An observational study of Coronary Artery Disease, run by Emory University at 2 sites in United States.
Trial summary
It is hypothesized that aging is associated with reduced vascular injury-induced endothelial progenitor cell activity, resulting in impaired vascular repair and increased vascular disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Percutaneous Coronary Angioplasty and Angiography
- Type of treatment
- Surgery or procedure
- How many people
- 123 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2006to 9 Oct 2008
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with stable coronary artery disease
Who may be able to join
- Patients having stable coronary artery disease and undergoing either angiography or angioplasty
Who cannot join
- Unstable coronary artery disease associated with either EKG changes or elevation of cardiac enzymes
- Coronary intervention in the past 3 months
- Renal insufficiency
- Malignancy within the past 5 years except non-melanomatous skin cancers
- Recent infection within the past 3 months requiring antibiotic treatment
- Recent surgery requiring anesthesia within the past 3 months
Show all 10Show fewer
- Having inflammatory disease
- Chemotherapy, radiation therapy or bone marrow stimulants at any time in the past
- Menstruating women
- Recent changes in statin, angiotensin-converting enzyme (ACE) inhibitors, or angiotensin receptor blocker doses
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Atlanta VA Medical Center
Atlanta, Georgia, 30033
Emory University Hospital
Atlanta, Georgia, 30322
About this study
Official title: The Effects of Age on Endothelial Progenitor Cell Mobilization in Humans
It is hypothesized that aging is associated with reduced vascular injury-induced endothelial progenitor cell activity, resulting in impaired vascular repair and increased vascular disease. Patients with stable coronary artery disease will be enrolled in this observational study and will undergo either angiography alone or angiography and angioplasty. Participants will be followed for 5 years.
Read the detailed description
Coronary artery disease is a leading cause of morbidity and mortality in our society. It is initiated by the dysfunction of the lining of coronary arteries. Such endothelial dysfunction permits vascular wall inflammation, smooth muscle cell proliferation, and thrombosis, which progresses to coronary artery stenosis and occlusion, and manifests as myocardial ischemia and infarction. Endothelial injury can be due to the damaging effects of various cardiovascular risk factors and it can also be induced by balloon injury associated with coronary angioplasty. Damaged endothelium can be repaired via endogenous mechanisms, such as by the migration and proliferation of neighboring uninjured mature endothelial cells, or by the mobilization and homing of bone-marrow-derived circulating endothelial progenitor cells (EPCs).
There are several repair mechanisms that are now thought to involve circulating endothelial progenitor cells that are mobilized from the bone marrow and home to sites of endothelial injury. The researchers of this study hypothesize that aging is associated with reduced vascular injury induced endothelial progenitor cell activity, resulting in impaired vascular repair and increased coronary heart disease events. Patients with stable coronary artery disease will be enrolled in this study. They will undergo either angiography alone or angiography and angioplasty. Venous blood will be collected immediately prior to the procedure and 20-24 hours after the procedure. The number of endothelial progenitor cells will be assessed based on their ability to form colonies and also to migrate under the influence of certain growth factors. These values will be compared between both samples. Study participants will also be contacted at 6 months, and 2 and 5 years after their participation in the study. The clinical outcomes of the participant's coronary artery disease will be correlated with the number of endothelial progenitor cells.
- Conditions
- Coronary Artery Disease
- Being tested
- Percutaneous Coronary Angioplasty, Angiography
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Coronary AngioplastyProcedure or surgery
This is a procedure by which the blood vessels of the heart are imaged with an insertion of a catheter in the groin and blocked arteries are opened.
AngiographyProcedure or surgery
Angiography is an imaging technique to see coronary blood vessels.
| Study group | Role | What they receive |
|---|---|---|
| Angiography | Patients undergoing coronary angiography without percutaneous coronary angioplasty Receives: Procedure: Angiography | |
| Percutaneous Coronary Angioplasty | Patients with stable coronary artery disease undergoing angioplasty Receives: Procedure: Percutaneous Coronary Angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in endothelial progenitor cells colony forming units
Activity of endothelial progenitor cells will be assessed in participants following their procedures.
Measured: 24 hours, 1 week, and 1 month after the procedure
Secondary outcomes (1)
Change in clinical outcomes of coronary artery disease
Participants will be contacted (or medical records will be examined) and asked if they have experienced cardiovascular disease outcomes such as myocardial infarction, stroke, hospitalization, coronary or peripheral revascularization, congestive heart failure exacerbation, or death.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2008 (estimated)
- Study startJul 2006
- Primary completion9 Oct 2008
- Study completion9 Oct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- American Federation for Aging Research
- Responsible party
- Principal investigator, Kreton Mavromatis, MD, FACC, Emory University
- Investigators
- Kreton Mavromatis, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00585949
- Sponsor's protocol ID
- IRB00045878
- Acronym
- AGE-PCI
- Status last verified
- Mar 2020
- First submitted
- 21 Dec 2007
- Last updated
- 5 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Age on Endothelial Progenitor Cell Mobilization in Humans
- ClinicalTrials.gov ID
- NCT00585949
- Acronym / sponsor ID
- AGE-PCI / IRB00045878
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- American Federation for Aging Research
- Study start
- Jul 2006
- Primary completion
- 9 Oct 2008 (actual)
- Study completion
- 9 Oct 2008 (actual)
- First posted
- 4 Jan 2008 (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.
It is hypothesized that aging is associated with reduced vascular injury-induced endothelial progenitor cell activity, resulting in impaired vascular repair and increased vascular disease. Patients with stable coronary artery disease will be enrolled in this observational study and will undergo either angiography alone or angiography and angioplasty. Participants will be followed for 5 years.
Detailed description
Coronary artery disease is a leading cause of morbidity and mortality in our society. It is initiated by the dysfunction of the lining of coronary arteries. Such endothelial dysfunction permits vascular wall inflammation, smooth muscle cell proliferation, and thrombosis, which progresses to coronary artery stenosis and occlusion, and manifests as myocardial ischemia and infarction. Endothelial injury can be due to the damaging effects of various cardiovascular risk factors and it can also be induced by balloon injury associated with coronary angioplasty. Damaged endothelium can be repaired via endogenous mechanisms, such as by the migration and proliferation of neighboring uninjured mature endothelial cells, or by the mobilization and homing of bone-marrow-derived circulating endothelial progenitor cells (EPCs).
There are several repair mechanisms that are now thought to involve circulating endothelial progenitor cells that are mobilized from the bone marrow and home to sites of endothelial injury. The researchers of this study hypothesize that aging is associated with reduced vascular injury induced endothelial progenitor cell activity, resulting in impaired vascular repair and increased coronary heart disease events. Patients with stable coronary artery disease will be enrolled in this study. They will undergo either angiography alone or angiography and angioplasty. Venous blood will be collected immediately prior to the procedure and 20-24 hours after the procedure. The number of endothelial progenitor cells will be assessed based on their ability to form colonies and also to migrate under the influence of certain growth factors. These values will be compared between both samples. Study participants will also be contacted at 6 months, and 2 and 5 years after their participation in the study. The clinical outcomes of the participant's coronary artery disease will be correlated with the number of endothelial progenitor cells.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Angiography | – | Procedure: AngiographyPatients undergoing coronary angiography without percutaneous coronary angioplasty |
| Percutaneous Coronary Angioplasty | – | Procedure: Percutaneous Coronary AngioplastyPatients with stable coronary artery disease undergoing angioplasty |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with stable coronary artery disease
Key inclusion criteria (1 listed)
- Patients having stable coronary artery disease and undergoing either angiography or angioplasty
Key exclusion criteria (10 listed)
- Unstable coronary artery disease associated with either EKG changes or elevation of cardiac enzymes
- Coronary intervention in the past 3 months
- Renal insufficiency
- Malignancy within the past 5 years except non-melanomatous skin cancers
- Recent infection within the past 3 months requiring antibiotic treatment
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 |
|---|---|---|
| Percutaneous Coronary AngioplastyThis is a procedure by which the blood vessels of the heart are imaged with an insertion of a catheter in the groin and blocked arteries are opened. | Procedure or surgery | Percutaneous Coronary Angioplasty |
| AngiographyAngiography is an imaging technique to see coronary blood vessels. | Procedure or surgery | Angiography |
Primary outcome
Change in endothelial progenitor cells colony forming units
Time frame: 24 hours, 1 week, and 1 month after the procedure
Activity of endothelial progenitor cells will be assessed in participants following their procedures.
1 secondary outcome
Change in clinical outcomes of coronary artery disease
Time frame: Up to 5 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 5 Mar 2020.
- 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.
Kreton Mavromatis, MD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Emory University at 2 sites 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 1 inclusion and 10 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 5 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Change in endothelial progenitor cells colony forming units (time frame: 24 hours, 1 week, and 1 month after the procedure). 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 5 Mar 2020.