- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00308633
Endothelial Progenitor Cells and Nitric Oxide in Cardiac Rehabilitation Program Participants
Mechanism and Vascular Effects of Endothelial Progenitor Cell Mobilization in Patients With Coronary Artery Disease Undergoing Cardiac Rehabilitation
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
-
Bethesda, Maryland, United States, 20814
- Suburban Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- INCLUSION CRITERIA:
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.
EXCLUSION CRITERIA:
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)
Study Plan
How is the study designed?
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 060122
- 06-H-0122
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Coronary Artery Disease (CAD)
-
National Institutes of Health Clinical Center (CC)National Heart, Lung, and Blood Institute (NHLBI)CompletedCoronary Arteriosclerosis | Coronary Artery Disease (CAD) | Obstructive Coronary Artery DiseaseUnited States
-
Assiut UniversityRecruitingCAD - Coronary Artery DiseaseEgypt
-
Johann Wolfgang Goethe University HospitalActive, not recruiting
-
Sinotau Pharmaceutical GroupCompletedCoronary Artery Disease (CAD)China
-
Astellas Pharma IncCompletedCoronary Artery Disease (CAD)United States
-
GE HealthcareCompletedCoronary Artery Disease (CAD)United States
-
Eli Lilly and CompanyDaiichi Sankyo Co., Ltd.TerminatedCoronary Artery Disease (CAD)United States, Germany
-
Anthera PharmaceuticalsCompletedCoronary Artery Disease (CAD)United States, Ukraine
-
GE HealthcarePharmaceutical Product Development, LLCCompletedCoronary Artery Disease (CAD)United States, Germany, Switzerland, Canada, Netherlands, France, Finland
-
Columbia UniversityTerminatedCoronary Artery Disease (CAD)United States