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Blood Collection for Research Related to Certain Diseases Involving Blood Vessels

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00047996
Recruitment Status : Recruiting
First Posted : October 23, 2002
Last Update Posted : February 20, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

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....

Condition or disease
Sickle Cell Disease

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.

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Study Type : Observational
Estimated Enrollment : 9999 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Human Specimen Collection to Support Basic and Clinical Research
Actual Study Start Date : October 16, 2002

Resource links provided by the National Library of Medicine


Group/Cohort
Subjects ages 2 and up
Clinical Center Patients, Children at CNMC, Healthy Volunteers



Primary Outcome Measures :
  1. Evaluating the role of nitric oxide, inflammatory mediators, and endothelial function in inflammatory diseases of the vasculaturesuch as sickle cell disease, coronary artery disease, pulmonary vascular or advanced lung disease, malaria, and s... [ Time Frame: Ongoing ]
    Evaluating the role of nitric oxide, inflammatory mediators, and endothelial function in inflammatory diseases of the vasculaturesuch as sickle cell disease, coronary artery disease, pulmonary vascular or advanced lung disease, malaria, and sepsis.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Normal subjects, greater than or equal to 2 years of age, Male/Female
Criteria
  • INCLUSION CRITERIA:

Males or females of age 2 years or 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00047996


Contacts
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Contact: James Nichols, R.N. (301) 402-2105 jim.nichols@nih.gov
Contact: Arun S Shet, M.D. (301) 538-2834 arun.shet@nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Arun S Shet, M.D. National Heart, Lung, and Blood Institute (NHLBI)

Additional Information:
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Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00047996    
Other Study ID Numbers: 030015
03-H-0015
First Posted: October 23, 2002    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 3, 2020
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):
DNA
Endothelial Function
Leukocyte Gene Expression
RNA
Sickle Cell
Coronary Artery Disease
CAD
Healthy Volunteer
HV
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn