Clinical trial NCT00047996: Blood Collection for Research Related to Certain Diseases Involving Blood Vessels
Official title: Human Specimen Collection to Support Basic and Clinical Research
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Sickle Cell Disease
Keywords: DNA
Endothelial Function
Leukocyte Gene Expression
RNA
Natural History
Sickle Cell
Coronary Artery Disease
CAD
Healthy Volunteer
HV
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2002-10-23
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Normal subjects, Male/Female

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.

Detailed description: 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.

Eligibility criteria: * INCLUSION CRITERIA:

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

EXCLUSION CRITERIA:

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.

There are no exclusion criteria for participants donating saliva or urine.

Primary outcomes:
measure: 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...
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
city: Fairfax
country: United States
facility: INOVA Fairfax Hosptial
state: Virginia
Study officials:
affiliation: National Heart, Lung, and Blood Institute (NHLBI)
name: Swee Lay Thein, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.