Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 16, 2021
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Human Specimen Collection to Support Basic and Clinical Research
Actual Study Start Date : November 4, 2002

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Normal subjects, Male/Female
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.

Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location contacts
Contact: James Nichols, R.N. (301) 755-7432 jnichols@mail.nih.gov
Contact: Arun S Shet, M.D. (301) 827-6808 arun.shet@nih.gov

Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Arun S Shet, M.D. National Heart, Lung, and Blood Institute (NHLBI)
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
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 16, 2021
Last Verified: February 4, 2021
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:
Layout table for MeSH terms
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn