Endothelial Progenitor Cells and Nitric Oxide in Cardiac Rehabilitation Program Participants

NCT00308633 | Completed

• 2 other identifiers: 06012206-H-0122
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 2

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.

Conditions

Coronary Artery Disease (CAD)

Keywords

Cardiac Rehabilitation; Apoptosis; Gene Expression; Nitric Oxide; Reactive Oxygen Species; Coronary Artery Disease; CAD

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (2)

Suburban Hospital

Bethesda, Maryland, 20814, United States

Location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Dimmeler S, Aicher A, Vasa M, Mildner-Rihm C, Adler K, Tiemann M, Rutten H, Fichtlscherer S, Martin H, Zeiher AM. HMG-CoA reductase inhibitors (statins) increase endothelial progenitor cells via the PI 3-kinase/Akt pathway. J Clin Invest. 2001 Aug;108(3):391-7. doi: 10.1172/JCI13152.

  PMID: 11489932 BACKGROUND

• Kalka C, Masuda H, Takahashi T, Kalka-Moll WM, Silver M, Kearney M, Li T, Isner JM, Asahara T. Transplantation of ex vivo expanded endothelial progenitor cells for therapeutic neovascularization. Proc Natl Acad Sci U S A. 2000 Mar 28;97(7):3422-7. doi: 10.1073/pnas.97.7.3422.

  PMID: 10725398 BACKGROUND

• Asahara T, Murohara T, Sullivan A, Silver M, van der Zee R, Li T, Witzenbichler B, Schatteman G, Isner JM. Isolation of putative progenitor endothelial cells for angiogenesis. Science. 1997 Feb 14;275(5302):964-7. doi: 10.1126/science.275.5302.964.

  PMID: 9020076 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: March 28, 2006
• First Posted: March 29, 2006
• Study Start: March 23, 2006
• Primary Completion: December 28, 2007
• Last Updated: July 2, 2017

Record last verified: 2009-10-30

Locations

US (2)