Age and Endothelial Progenitor Cell Mobilization

Coronary Artery Disease Clinical Trial

— AGE-PCI  

Official title:

The Effects of Age on Endothelial Progenitor Cell Mobilization in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00585949
• Other study ID #: IRB00045878
• Status: Completed
• Start date: July 2006
• Est. completion date: October 9, 2008

Study information

• Verified date: March 2020
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: October 9, 2008
• Est. primary completion date: October 9, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

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.
• Angiography
Angiography is an imaging technique to see coronary blood vessels.

Locations

Country	Name	City	State
United States	Atlanta VA Medical Center	Atlanta	Georgia
United States	Emory University Hospital	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	American Federation for Aging Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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