Blood Collection for Research Related to Certain Diseases Involving Blood Vessels

NCT00047996 | Enrolling By Invitation

• 2 other identifiers: 03001503-H-0015
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 2

Brief Summary

The collection of human specimens from both patients and healthy volunteers is necessary for the development of laboratory assays to further basic and clinical research studies. This protocol defines the purposes for which specimens will be collected and establishes general conditions under which sample collection will be performed.

Conditions

Sickle Cell Disease

Keywords

DNA; Endothelial Function; Leukocyte Gene Expression; RNA; Natural History; Sickle Cell; Coronary Artery Disease; CAD; Healthy Volunteer; HV

Outcome Measures

Primary Outcomes (1)

• evaluating the role of nitric oxide, inflammatory mediators, and endothelial function in inflammatory diseases of the vasculature such as sickle cell disease, coronary artery disease, pulmonary vascular or advanced lung disease, malaria, and sep...

Study Arms (1)

Group1

Clinical Center Patients, Healthy Volunteers

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Normal subjects, Male/Female

You may qualify if:

• Males or females of age 18 years and older can be included in the study.

You may not qualify if:

• Individuals without sickle cell disease or other chronic anemias who wish to donate blood will be excluded if the hemoglobin is less than 10 g/dL for women or less than 12g/dL for men.
• Individuals with sickle cell disease or other chronic anemias will be excluded from donating blood samples if the hemoglobin is less than 6 g/dL.
• A participant s most recent CBC result, obtained in the past 12 months, will be used to determine eligibility.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (2)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

INOVA Fairfax Hosptial

Fairfax, Virginia, 22042, United States

Location

Related Publications (1)

• Tumburu L, Ghosh-Choudhary S, Seifuddin FT, Barbu EA, Yang S, Ahmad MM, Wilkins LHW, Tunc I, Sivakumar I, Nichols JS, Dagur PK, Yang S, Almeida LEF, Quezado ZMN, Combs CA, Lindberg E, Bleck CKE, Zhu J, Shet AS, Chung JH, Pirooznia M, Thein SL. Circulating mitochondrial DNA is a proinflammatory DAMP in sickle cell disease. Blood. 2021 Jun 3;137(22):3116-3126. doi: 10.1182/blood.2020009063.

  PMID: 33661274 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Anemia, Sickle Cell; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Swee Lay Thein, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2006
• First Posted: October 23, 2002
• Study Start: November 4, 2002
• Last Updated: June 5, 2026

Record last verified: 2026-06-03

Locations

US (2)