Protocol Number: 03-CC-0015

Title:

Collection of Blood from Volunteers and Patients for Studies of Endothelial Function and Systemic Inflammation

Number:

03-CC-0015

Summary:

This study will collect blood from healthy volunteers and from patients with certain inflammatory diseases involving blood vessels. The blood will be used to study genes, proteins and the lining cells of blood vessels in patients with inflammatory diseases involving blood vessels. The blood will also be used for developing new tests to study these diseases.

Normal volunteers and patients with the following diseases or conditions may be eligible for this study:

- Sickle cell disease

- Arteriosclerosis (hardening of the arteries)

- Hemolytic diseases (diseases involving destruction of red blood cells)

- Sepsis (infection of the blood or other tissues)

- Other diseases involving inflammation and the endothelium (lining cells of the heart, blood and lymph vessels, and cavities of the body)

Participants must be at least 5 years old.

All participants will give a medical history and have a physical examination. Sickle cell patients and healthy volunteers will have tests to determine if they have sickle cell disease, sickle cell trait, or beta-thalassemia. All participants will donate blood from either a vein or an artery. To collect blood from a vein, a needle is placed in a vein in the bend of the elbow and blood is drawn into several syringes or tubes. To collect blood from an artery, a needle is placed in an artery in the arm above the elbow or in an artery on the wrist and blood is drawn into several syringes or tubes. (Arterial blood will be drawn only from participants 18 years of age or older.) No more than 450 ml (about 1 pint) of blood will be collected from any donor over an 8-week period.

Sponsoring Institute:

National Institutes of Health Clinical Center (CC)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA FOR SICKLE CELL PATIENTS:

Males or females of age 5 years and above.

Diagnosis of sickle cell disease (electrophoretic documentation of SS, SC, or S Beta (0) thalassemia or S alpha thalassemia genotype is required).

Hematocrit greater than 18 percent (with an absolute reticulocyte count greater than 100,000/microL if hematocrit is 18-24 percent).

EXCLUSION CRITERIA FOR SICKLE CELL PATIENTS:

Current pregnancy or lactation.

INCLUSION CRITERIA FOR PATIENTS WITH ARTERIOSCLEROSIS, OTHER HEMOLYTIC DISEASES, SEPSIS OR OTHER DISEASES INVOLVING INFLAMMATION AND ENDOTHELIAL DYSFUNCTION OR REQUIRING RED CELL TRANSFUSION, AND PULMONARY VASCULAR OR ADVANCED LUNG DISEASE:

Males or females of age 5 years and above (subjects from INOVA Fairfax will be 18 years or older).

Hematocrit greater than 21percent (with an absolute reticulocyte count greater than 100,000/microL if/when hematocrit is 21-24 percent).

Patients undergoing myelosuppressive chemotherapy will be eligible if their hematocrit is greater than 18 percent (with no reticulocyte count needed), the amount of blood obtained is no more than 30 mL and the draws are performed immediately prior and/or after red blood cell transfusion is given.

EXCLUSION CRITERIA FOR PATIENTS WITH ARTERIOSCLEROSIS, OTHER HEMOLYTIC DISEASES, SEPSIS OR OTHER DISEASES INVOLVING INFLAMMATION AND ENDOTHELIAL DYSFUNCTION OR REQUIRING RED CELL TRANSFUSION AND PULMONARY VASCULAR OR ADVANCED LUNG DISEASE:

Current pregnancy or lactation.

INCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:

Males or females of age 5 years and above.

Normal hematocrit.

EXCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:

Current pregnancy or lactation.

Hematocrit below normal (e.g. below 31percent for females and below 36.7 percent for males) however, patients may return for evaluation at a later date.

INCLUSION CRITERIA FOR CHILDREN AT CNMC:

Males or females of age 3 years and above.

Disorders of organic amino acid metabolism/intermediary metabolism.

Scheduled for a routine blood draw at CNMC.

EXCLUSION CRITERIA FOR CHILDREN AT CNMC:

Weight less than 15 kg regardless of age.

Suspected anemia.

Special Instructions:

Currently Not Provided

Keywords:

DNA

Endothelial Function

Leukocyte Gene Expression

RNA

Recruitment Keyword(s):

Sickle Cell

Coronary Artery Disease

CAD

Healthy Volunteer

HV

Condition(s):

Endothelial Function

Systemic Inflammation

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

Warren G. Magnuson Clinical Center

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Ignarro LJ, Byrns RE, Buga GM, Wood KS. Endothelium-derived relaxing factor from pulmonary artery and vein possesses pharmacologic and chemical properties identical to those of nitric oxide radical. Circ Res. 1987 Dec;61(6):866-79.

Palmer RM, Ferrige AG, Moncada S. Nitric oxide release accounts for the biological activity of endothelium-derived relaxing factor. Nature. 1987 Jun 11-17;327(6122):524-6.

Palmer RM, Ashton DS, Moncada S. Vascular endothelial cells synthesize nitric oxide from L-arginine. Nature. 1988 Jun 16;333(6174):664-6.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Clinical Research Informatics, CC.

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