Age and Endothelial Progenitor Cell Mobilization

NCT ID: NCT00585949

Last Updated: 2020-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

123 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-07-31

Study Completion Date

2008-10-09

Brief Summary

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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

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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

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Coronary Artery Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Angiography

Patients undergoing coronary angiography without percutaneous coronary angioplasty

Angiography

Intervention Type PROCEDURE

Angiography is an imaging technique to see coronary blood vessels.

Percutaneous Coronary Angioplasty

Patients with stable coronary artery disease undergoing angioplasty

Percutaneous Coronary Angioplasty

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Angiography

Angiography is an imaging technique to see coronary blood vessels.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Federation for Aging Research

OTHER

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role lead

Responsible Party

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Kreton Mavromatis, MD, FACC

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kreton Mavromatis, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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Atlanta VA Medical Center

Atlanta, Georgia, United States

Site Status

Emory University Hospital

Atlanta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00045878

Identifier Type: -

Identifier Source: org_study_id

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