Age and Endothelial Progenitor Cell Mobilization (AGE-PCI)
The Effects of Age on Endothelial Progenitor Cell Mobilization in Humans
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University Hospital
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Atlanta, Georgia, United States, 30033
- Atlanta VA Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients having stable coronary artery disease and undergoing either angiography or angioplasty
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Angiography
Patients undergoing coronary angiography without percutaneous coronary angioplasty
|
Angiography is an imaging technique to see coronary blood vessels.
|
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Percutaneous Coronary Angioplasty
Patients with stable coronary artery disease undergoing angioplasty
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in endothelial progenitor cells colony forming units
Time Frame: 24 hours, 1 week, and 1 month after the procedure
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Activity of endothelial progenitor cells will be assessed in participants following their procedures.
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24 hours, 1 week, and 1 month after the procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in clinical outcomes of coronary artery disease
Time Frame: Up to 5 years
|
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.
|
Up to 5 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kreton Mavromatis, MD, Emory University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00045878
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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