Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00090558
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2004-08-27
Brief Title:
Effect of Nitric Oxide Donor on Endothelial Progenitor Cells in Patients With Coronary Artery Disease
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Effect of Nitric Oxide Donor on Endothelial Progenitor Cells in Patients With Coronary Artery Disease
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Regular exercise reduces the risk of heart problems in part because it improves the work of the endothelium the cells that line blood vessels Exercise appears to release precursor cells from the bone marrow that will later become endothelial cells A molecule called nitric oxide NO appears to be involved in this release However some heart patients do not improve their endothelial function despite regular exercise The researchers believe that the heart disease in these patients may interfere with the normal relationship between exercise and endothelial function This study is designed to test whether giving a patient nitroglycerin which is converted to NO in the bloodstream will increase the release of endothelial precursor cells from the bone marrow If the study succeeds it may lead to improved healing of arteries in heart disease patients
Adults may be eligible for this study if they have coronary artery disease and do not take nitroglycerin or nitroglycerin-like medication on a daily basis
Volunteers will be admitted to the Clinical Center on 2 separate nights at least 1 week apart On the morning after each admission volunteers will have blood drawn from an arm vein for laboratory tests and then walk on a treadmill until fatigue or discomfort prevents further exercise or until asked to stop On one of their admissions volunteers will receive 1 tablet of nitroglycerin under the tongue shortly before the treadmill test Volunteers will be monitored by EKGs and blood pressure tests during the treadmill tests and will have more blood drawn at about 15 minutes and 24 hours after each treadmill test Researchers will examine the levels of endothelial precursor cells and nitric oxide in the blood samples taken before and after exercise
Adults may be eligible for this study if they have coronary artery disease and do not take nitroglycerin or nitroglycerin-like medication on a daily basis
Volunteers will be admitted to the Clinical Center on 2 separate nights at least 1 week apart On the morning after each admission volunteers will have blood drawn from an arm vein for laboratory tests and then walk on a treadmill until fatigue or discomfort prevents further exercise or until asked to stop On one of their admissions volunteers will receive 1 tablet of nitroglycerin under the tongue shortly before the treadmill test Volunteers will be monitored by EKGs and blood pressure tests during the treadmill tests and will have more blood drawn at about 15 minutes and 24 hours after each treadmill test Researchers will examine the levels of endothelial precursor cells and nitric oxide in the blood samples taken before and after exercise
Detailed Description:
Exercise training has long been recommended as a means of improving cardiac function and reducing morbidity and mortality in patients with coronary artery disease CAD One mechanism of benefit may be through improved endothelial function and enhanced nitric oxide NO bioactivity which may improve blood flow to exercising skeletal muscle and to the myocardium We have recently determined in a collaborative study with the Suburban Hospital however that many CAD patients do not show improved endothelial function despite compliant participation in a three month cardiac rehabilitation program with exercise three times weekly The initial data from this study suggest that improvement in endothelial function may be dependent on the release of endothelial progenitor cells EPCs from the bone marrow into the circulation in response to the stimulus of repetitive exercise with the potential of repairing damaged endothelium and improving endothelial function and NO release Thus patients who have poor EPC mobilization responses to exercise may have limited capacity to improve endothelial function over time and conversely patients with higher EPC mobilization responses to exercise may show improved endothelial function as a result of vascular repair Animal models indicate that NO is necessary for EPC mobilization during exercise likely through nitrosation reactions with key signaling proteins within bone marrow In many CAD patients NO release from endothelium and transport in blood to bone marrow may be compromised because of atherosclerotic vascular disease and thus limit EPC mobilization and vascular repair We hypothesize that the exogenous administration of NO to CAD patients may enhance EPC mobilization from bone marrow in response to exercise If successful administration of an NO donor such as nitroglycerin prior to exercise may extend the benefit of exercise to endothelial function-and thus cardiovascular risk-in a larger segment of CAD patients participating in cardiac rehabilitation programs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-H-0268 | None | None | None |