- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Type d'étude
Inscription
Contacts et emplacements
Lieux d'étude
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Maryland
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Bethesda, Maryland, États-Unis, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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Bethesda, Maryland, États-Unis, 20814
- Suburban Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La 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)
Plan d'étude
Comment l'étude est-elle conçue ?
Collaborateurs et enquêteurs
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 060122
- 06-H-0122
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