Status:
COMPLETED
Model System for Transient Forearm Blood Vessel Dysfunction
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Limb Ischemia
Ischemic Preconditioning
Eligibility:
MALE
18-45 years
Phase:
PHASE1
PHASE2
Brief Summary
This study will develop a model system that can be used to test medications for improving the ability of blood vessels to resist damage from diseases such as heart attack and stroke. The endothelium (...
Detailed Description
Endothelial dysfunction denotes abnormal contractile function of the inner lining of blood vessels. Endothelial dysfunction is associated with hypertension, hypercholesterolemia, atherosclerosis and d...
Eligibility Criteria
Inclusion
- ELIGIBILITY:
- Up to 20 healthy volunteers will be screened in order to obtain 10 completed studies. All volunteer subjects will undergo screening with complete history, cardiovascular physical examination, electrocardiogram, blood collection for clinical chemistry routine analyses and complete blood count, cholesterol, fasting blood glucose, PT and PTT.
- INCLUSION CRITERIA:
- Subjects must be 18-45 years of age.
- Subjects must be male.
- Subject must be in good health.
- Subject must complete a screening history and physical exam.
- Subjects must provide informed, written consent for participation in this study.
- EXCLUSION CRITERIA:
- Subjects with a history of cardiac, pulmonary, peripheral vascular disease, coagulopathy, or any other disease predisposing to vasculitis or Raynaud's phenomenon.
- Subjects with diabetes or mitochondrial disease.
- Subjects with a history or evidence of present or past hypertension (blood pressure greater than 140/90 mmHg), hypercholesterolemia (LDL cholesterol greater than 160 mg/dL).
- Subjects with abnormal EKG other than sinus bradycardia.
- Subjects who have a history of smoking within three months.
- Subjects with anemia (defined as hemoglobin less than 9 g/dL).
- BMI greater than 30
- No volunteer subject will be allowed to take any prescription medication. Vitamin supplements, herbal preparations, nutraceuticals or other alternative therapies must be stopped for two weeks prior to study and aspirin, tylenol and NSAIDs must also be discontinued two weeks prior to study.
- Subjects with a blood pressure of less than 90/60 mmHg or mean arterial pressure (MAP) less than 70 mmHg on the study day will be excluded from the protocol.
- Positive for HIV or Hepatitis B, C.
Exclusion
Key Trial Info
Start Date :
March 26 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 11 2009
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00453531
Start Date
March 26 2007
End Date
February 11 2009
Last Update
August 9 2022
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892