Age and Endothelial Progenitor Cell Mobilization (AGE-PCI)

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Procedure: Angiography; Procedure: Percutaneous Coronary Angioplasty

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: Observational
• Enrollment (Actual): 123

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
    • Atlanta, Georgia, United States, 30033
      • Atlanta VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with stable coronary artery disease

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

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Angiography; Patients undergoing coronary angiography without percutaneous coronary angioplasty	Procedure: Angiography; Angiography is an imaging technique to see coronary blood vessels.
Percutaneous Coronary Angioplasty; Patients with stable coronary artery disease undergoing angioplasty	Procedure: Percutaneous 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in endothelial progenitor cells colony forming units	Activity of endothelial progenitor cells will be assessed in participants following their procedures.	24 hours, 1 week, and 1 month after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 5 years

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: American Federation for Aging Research
• Investigators: Principal Investigator: Kreton Mavromatis, MD, Emory University

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (Actual): October 9, 2008
• Study Completion (Actual): October 9, 2008

Study Registration Dates

• First Submitted: December 21, 2007
• First Submitted That Met QC Criteria: December 21, 2007
• First Posted (Estimate): January 4, 2008

Study Record Updates

• Last Update Posted (Actual): March 5, 2020
• Last Update Submitted That Met QC Criteria: March 2, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: IRB00045878

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No