Status:
RECRUITING
Samples From Human Subjects to Facilitate Basic, Translational and Clinical Research
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Conditions:
Endothelial Dysfunction
Inflammation in Cardiopulmonary and Vascular Disease States
Eligibility:
All Genders
18-100 years
Brief Summary
Background: This study is designed to provide samples to help us study the genes your blood cells are making as well as the proteins, sugars, fats, vitamins and other metabolites found in your blood ...
Detailed Description
Our department is evaluating various aspects of the cardiovascular system and/or endothelial dysfunction and/or inflammation in disease states, such as, but not limited to, pulmonary hypertension (PH)...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA FOR RESEARCH SUBJECTS WITH DISEASES RELATED TO CARDIOVASCULAR SYSTEM AND/OR INFLAMMATION AND/OR ENDOTHELIAL DYSFUNCTION SUCH AS BUT NOT LIMITED TO ARTERIOSCLEROSIS, TRANSPLANTATION, PULMONARY HYPERTENSION, OTHER ADVANCED LUNG OR HEART DISEASE
- Males or females of age greater than or equal to 18 years old.
- Subjects unable to provide informed consent must have a surrogate decision maker or another legally authorized representative (such as a legal guardian or holder of the DPA)
- EXCLUSION CRITERIA FOR RESEARCH SUBJECTS WITH DISEASES RELATED TO CARDIOVASCULAR SYSTEM AND/OR INFLAMMATION AND/OR ENDOTHELIAL DYSFUNCTION SUCH AS BUT NOT LIMITED TO ARTERIOSCLEROSIS, TRANSPLANTATION, PULMONARY HYPERTENSION, OTHER ADVANCED LUNG OR HEART DISEASE
- Hemoglobin \<7.0 g/dL
- Currently receiving infusion of epinephrine; or dopamine at an infusion rate of \>2.5 microgram/kg/min, norepinephrine of \> 20mcg/min, or vasopressin \> 0.04 units/min\*
- In the presence of known coronary artery disease (CAD) a systolic blood pressure (SBP) \<90 mmHg. In the absence of known CAD a SBP \<80 mmHg or mean arterial pressure (MAP) \<60 mmHg with or without vasopressors\*.
- For critically ill patients with shock (on vasopressors), no more than 20mL of blood may be obtained within a 24 hour period. (No more than 200ml over eight weeks.)
- Research subjects may be excluded if in the opinion of the study investigators they have a condition that may adversely affect the outcome of the study or the safety of the volunteer.
- INCLUSION CRITERIA FOR SUBJECTS WHO ARE TO RECEIVE CRRT (IRRESPECTIVE OF DIAGNOSIS) IN WHOM THE TOTAL AMOUNT OF PROTOCOL RELATED BLOOD WILL NOT EXCEED 8 ML.
- Males or females of age greater than or equal to 18 years old.
- Subjects unable to provide informed consent must have a surrogate decision maker or another legally authorized representative (such as a legal guardian or holder of the DPA)
- EXCLUSION CRITERIA FOR SUBJECTS WHO ARE TO RECEIVE CRRT (IRRESPECTIVE OF DIAGNOSIS) IN WHOM THE TOTAL AMOUNT OF PROTOCOL RELATED BLOOD WILL NOT EXCEED 8 ML)
- Hemoglobin \<7.0 g/dL
- In the presence of known coronary artery disease (CAD) a systolic blood pressure (SBP) \<90 mmHg. In the absence of known CAD a SBP \<80 mmHg or mean arterial pressure (MAP) \<60 mmHg.
- INCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:
- Males or females of age greater than or equal to 18 years old
- Ability of subjects to understand and the willingness to sign an informed consent document.
- EXCLUSION CRITERIA FOR HEATLHY VOLUNTEERS:
- Blood or platelet donation within the last 6 weeks.
- Hemoglobin below normal (e.g. below 11.2 g/dl for females and below 13.7 mg/dl for males at the NIH CC); subjects may return for evaluation at a later date. (After initial enrollment, hematocrit does not need to be done prior to subsequent blood draws unless there is interval development of symptomatic anemia)
- History of recreational drug use with the exception of marijuana (as long as marijuana use was \>3 months from the time of study screening).
- Active acute illness (i.e viral syndrome). Subjects may return for evaluation at a later date once the acute illness resolves.
- Volunteers may be excluded if in the opinion of the study investigators they have a condition that may adversely affect the outcome of the study or the safety of the volunteer, such as, active tobacco use (\> 6 months) in the past ten years, any tobacco use within 3 months prior to the screening evaluation, a history of clinically relevant and active cardiopulmonary disease (e.g. Including but not limited to any cardiopulmonary diseases not well controlled by medications, EKG with evidence of clinically relevant heart disease, COPD with hypoxemia and forced expiratory volume/forced vital capacity (FEV1/FVC) \> 2 standard deviations from normal, etc.).
Exclusion
Key Trial Info
Start Date :
September 14 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT03253705
Start Date
September 14 2017
End Date
August 1 2027
Last Update
November 25 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892