Endothelial Progenitor Cells and Nitric Oxide in Cardiac Rehabilitation Program Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00308633
Recruitment Status : Completed
First Posted : March 29, 2006
Last Update Posted : July 2, 2017
Information provided by:
National Institutes of Health Clinical Center (CC)

Brief Summary:

This study will measure blood levels of endothelial progenitor cells (EPCs) and nitric oxide (NO) in patients with coronary artery disease (CAD) who are participating in a 3-month cardiac rehabilitation program at Suburban Hospital in Bethesda, MD. EPCs are a kind of stem cell produced by the bone marrow that can develop into cells found in arteries and in the heart and, therefore, can repair diseased vessels. The study will examine whether the EPCs are affected by exercise and will look at how they may contribute to repair of cells lining the diseased arteries as a result of participation in the rehabilitation program.

People with coronary artery disease may be eligible for this study. Candidates are screened with a medical history, physical examination, electrocardiogram, and blood tests. CAD patients also to a treadmill exercise test.

Volunteers' participation ends at the screening visit. The blood drawn at screening is used to identify EPC specific genes to compare with the EPC genes from patients with CAD.

CAD patients participate in Suburban Hospital's cardiac rehabilitation program. The exercise portion of the program includes 36 sessions of about 60 minutes each, spaced over approximately 3 months. Patients have a baseline blood test at screening and repeat blood tests at the end of each month of participation in the rehabilitation program. Some of the blood will be used for genetic tests to see how genes of the EPCs are changed by the patient's participation in the rehabilitation program.

Condition or disease
Coronary Artery Disease (CAD)

Detailed Description:
Exercise training has long been recommended as a means of improving effort tolerance and reducing morbidity and mortality in patients with coronary artery disease (CAD). One mechanism of benefit may be through improved endothelial function with enhanced nitric oxide (NO) bioactivity. Such an effect may augment blood flow to exercising skeletal muscle and to the myocardium, and reduce vascular inflammation, platelet activation and adherence which could diminish the risk of thrombosis. In 46 patients with CAD, participating in the Suburban Hospital cardiac rehabilitation program (Protocol 03-H-0086), we detected increases in circulating endothelial progenitor cells (EPCs), which may have the capacity to repair diseased or dysfunctional endothelium. In the last 23 participants (following amendment of the protocol) a subset showed increase in whole blood nitrite - a marker of intravascular NO - at completion of program. However, not all patients showed EPC mobilization or increased intravascular NO despite compliant program participation and improved effort tolerance. One possibility is that EPCs from patients who fail to derive vascular benefit as evidenced by increased intravascular NO may have different EPC gene expression profiles at baseline or in response to repetitive exercise, resulting in diminished protection of EPCs against oxidant stress with initiation of apoptosis, compared with EPC gene expression in patients who show evidence of EPC mobilization and endothelial repair. The purpose of our study is to 1) Prospectively demonstrate a relationship between EPC mobilization and increased whole blood nitrite as a marker of improved vascular NO bioactivity due to EPC mobilization, and 2) Determine EPC gene expression profiles, with a focus on activation or suppression of genes whose products regulate intravascular redox potential, apoptosis and growth factor and cytokine secretion. We hypothesize that activation or suppression of critical genes in EPCs at baseline or during exercise may determine EPC mobilization, endothelial differentiation and vascular repair potential as evidenced by increased intravascular NO.

Study Type : Observational
Estimated Enrollment : 55 participants
Official Title: Mechanism and Vascular Effects of Endothelial Progenitor Cell Mobilization in Patients With Coronary Artery Disease Undergoing Cardiac Rehabilitation
Study Start Date : March 23, 2006
Primary Completion Date : December 28, 2007

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Adults older than 21 years.

Coronary artery disease established by angiography.

At least two months interval since myocardial infarction or coronary artery bypass surgery.

At least one month interval since percutaneous coronary intervention or congestive heart failure symptoms.

No medical condition that might prohibit safe participation in cardiac rehabilitation.

Subject understands protocol and provides written, informed consent in addition to willingness to comply with specified follow-up evaluations.


Significant structural heart disease (e.g. hypertrophic or dilated cardiomyopathy, valvular heart disease) as determined by echocardiography.

Angina pectoris that is prolonged in duration (greater than 20 minutes), or does not respond to nitroglycerin (2 tablets) within 2 weeks of referral to the program.

Subjects physically unable to perform cardiac rehabilitation protocol due to neurologic or orthopedic conditions.

Women of childbearing age unless recent pregnancy test is negative.

Lactating women.

Implantable cardioverter-defibrillator (ICD)

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00308633

United States, Maryland
Suburban Hospital
Bethesda, Maryland, United States, 20814
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

Publications: Identifier: NCT00308633     History of Changes
Other Study ID Numbers: 060122
First Posted: March 29, 2006    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: October 30, 2009

Keywords provided by National Institutes of Health Clinical Center (CC):
Cardiac Rehabilitation
Gene Expression
Nitric Oxide
Reactive Oxygen Species
Coronary Artery Disease

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Protective Agents