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CompletedNCT00585949AGE-PCIUpdated Mar 5, 2020

Age and Endothelial Progenitor Cell Mobilization

An observational study in Coronary Artery Disease, sponsored by Emory University. Completed at 2 sites in United States. Per ClinicalTrials.gov, last updated 2020-03-05.

Sponsored by Emory University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
123
Sex
All
01

Study 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. 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.

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Conditions studied

  • Coronary Artery Disease
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In context

Coronary Artery Disease

5,676 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.

This study's enrollment of 123 is below the median of 335 across 1,978 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Emory University is the lead sponsor of 1,405 studies on the registry; 233 are open to participants now.

Of its 233 completed or terminated interventional studies of FDA-regulated products, 176 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with stable coronary artery disease

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients having stable coronary artery disease and undergoing either angiography or angioplasty

Exclusion criteria

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
123 participants (actual)
Patient registry
No

Groups and cohorts

  • Angiography

    Patients undergoing coronary angiography without percutaneous coronary angioplasty

    Procedure: Angiography

  • Percutaneous Coronary Angioplasty

    Patients with stable coronary artery disease undergoing angioplasty

    Procedure: Percutaneous Coronary Angioplasty

Interventions

  • ProcedurePercutaneous Coronary Angioplasty

    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.

  • ProcedureAngiography

    Angiography is an imaging technique to see coronary blood vessels.

06

What researchers measure

Primary outcomes

  1. Change in endothelial progenitor cells colony forming units

    Activity of endothelial progenitor cells will be assessed in participants following their procedures.

    Time frame: 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.

    Time frame: Up to 5 years

07

Study locations

2 sites
  • Atlanta VA Medical Center
    Atlanta, Georgia 30033, United States
  • Emory University Hospital
    Atlanta, Georgia 30322, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2006, a primary completion of Oct 2008 and a completion of Oct 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 21, 2007
First posted
Jan 4, 2008
Start
Jul 2006
Primary completionActual
Oct 9, 2008
CompletionActual
Oct 9, 2008
Last update
Mar 5, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00585949
Lead sponsor
Emory University
Collaborators
American Federation for Aging Research
Responsible party
Kreton Mavromatis, MD, FACC (Associate Professor, Emory University) — Principal investigator
First posted
Jan 4, 2008
Start date
Jul 2006
Primary completion
Oct 9, 2008
Completion
Oct 9, 2008
Last update
Mar 5, 2020

Study contacts

Kreton Mavromatis, MD
principal investigator · Emory University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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