<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03253705</url>
  </required_header>
  <id_info>
    <org_study_id>170148</org_study_id>
    <secondary_id>17-CC-0148</secondary_id>
    <nct_id>NCT03253705</nct_id>
  </id_info>
  <brief_title>Samples From Human Subjects to Facilitate Basic, Translational and Clinical Research</brief_title>
  <official_title>Obtaining Samples From Human Subjects to Facilitate Basic, Translational and Clinical Research</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institutes of Health Clinical Center (CC)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      This study is designed to provide samples to help us study the genes your blood cells are&#xD;
      making as well as the proteins, sugars, fats, vitamins and other metabolites found in your&#xD;
      blood or urine. Blood samples may also be collected to make special cells. These are called&#xD;
      induced pluripotent stem cells or iPSCs. Pluripotent stem cells are cells that can be&#xD;
      converted into any type of cell. Researchers want to study in the lab iPSCs that are derived&#xD;
      from blood samples.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      To collect samples to help study genes, proteins, sugars, fats, vitamins, and other&#xD;
      metabolites found in blood or urine.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      Healthy volunteers and patients ages 18 and older&#xD;
&#xD;
      Design:&#xD;
&#xD;
      First-time research study participants at NIH will have an initial visit for this study that&#xD;
      should last no more than 1 hour. All other visits should last 20 30 minutes.&#xD;
&#xD;
      Participants will undergo a limited history and physical exam.&#xD;
&#xD;
      Participants may have routine blood and urine tests.&#xD;
&#xD;
      If participants are giving a blood sample, they must have a hemoglobin level checked in the&#xD;
      past 12 months to make sure it is safe for them to give a blood sample for research.&#xD;
&#xD;
      Participants may have a venous blood collection. They may do this at several visits. They&#xD;
      will lie on a recliner or couch or sit in a chair. A needle will be placed into a vein in the&#xD;
      hand or arm, using sterile techniques. Blood will be withdrawn into multiple syringes or&#xD;
      tubes.&#xD;
&#xD;
      Participants may be asked to provide urine in an appropriate container...&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Our department is evaluating various aspects of the cardiovascular system and/or endothelial&#xD;
      dysfunction and/or inflammation in disease states, such as, but not limited to, pulmonary&#xD;
      hypertension (PH) and other pulmonary vascular diseases, arteriosclerosis, transplantation,&#xD;
      inflammatory processes and sepsis. The collection of human blood and urine from both research&#xD;
      subjects and healthy volunteers is necessary for the development of relevant laboratory&#xD;
      assays and protocols, and to further research studies requiring such evaluations. In research&#xD;
      subjects undergoing renal replacement therapy who produce limited urine we may also sample&#xD;
      ultrafiltrate as a surrogate for urine. This protocol defines in general terms the purposes&#xD;
      for which blood, urine and ultrafiltrate will be collected by members of the NIH s Clinical&#xD;
      Center (CC), Critical Care Medicine Department (CCMD) and collaborating institutions and&#xD;
      establishes general conditions under which sampling will be performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 14, 2017</start_date>
  <completion_date type="Anticipated">August 1, 2027</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2027</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Exploratory assay development</measure>
    <time_frame>10 years</time_frame>
    <description>Development of new assays</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Endothelial Dysfunction</condition>
  <condition>Inflammation in Cardiopulmonary and Vascular Disease States</condition>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Controls</arm_group_label>
    <description>Healthy Controls</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Research Subjects</arm_group_label>
    <description>Research Subjects already enrolled on other NIH protocols</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy Volunteers who donate samples of assay development and Research Subjects who donate&#xD;
        samples of assay development.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        -  INCLUSION CRITERIA FOR RESEARCH SUBJECTS WITH DISEASES RELATED TO CARDIOVASCULAR&#xD;
             SYSTEM AND/OR INFLAMMATION AND/OR ENDOTHELIAL DYSFUNCTION SUCH AS BUT NOT LIMITED TO&#xD;
             ARTERIOSCLEROSIS, TRANSPLANTATION, PULMONARY HYPERTENSION, OTHER ADVANCED LUNG OR&#xD;
             HEART DISEASE&#xD;
&#xD;
               1. Males or females of age greater than or equal to 18 years old.&#xD;
&#xD;
               2. Subjects unable to provide informed consent must have a surrogate decision maker&#xD;
                  or another legally authorized representative (such as a legal guardian or holder&#xD;
                  of the DPA)&#xD;
&#xD;
        EXCLUSION CRITERIA FOR RESEARCH SUBJECTS WITH DISEASES RELATED TO CARDIOVASCULAR SYSTEM&#xD;
        AND/OR INFLAMMATION AND/OR ENDOTHELIAL DYSFUNCTION SUCH AS BUT NOT LIMITED TO&#xD;
        ARTERIOSCLEROSIS, TRANSPLANTATION, PULMONARY HYPERTENSION, OTHER ADVANCED LUNG OR HEART&#xD;
        DISEASE&#xD;
&#xD;
          1. Hemoglobin &lt;7.0 g/dL&#xD;
&#xD;
          2. Currently receiving infusion of epinephrine; or dopamine at an infusion rate of &gt;2.5&#xD;
             microgram/kg/min, norepinephrine of &gt; 20mcg/min, or vasopressin &gt; 0.04 units/min*&#xD;
&#xD;
          3. In the presence of known coronary artery disease (CAD) a systolic blood pressure (SBP)&#xD;
             &lt;90 mmHg. In the absence of known CAD a SBP &lt;80 mmHg or mean arterial pressure (MAP)&#xD;
             &lt;60 mmHg with or without vasopressors*.&#xD;
&#xD;
               -  For critically ill patients with shock (on vasopressors), no more than 20mL of&#xD;
                  blood may be obtained within a 24 hour period. (No more than 200ml over eight&#xD;
                  weeks.)&#xD;
&#xD;
        Research subjects may be excluded if in the opinion of the study investigators they have a&#xD;
        condition that may adversely affect the outcome of the study or the safety of the&#xD;
        volunteer.&#xD;
&#xD;
        INCLUSION CRITERIA FOR SUBJECTS WHO ARE TO RECEIVE CRRT (IRRESPECTIVE OF DIAGNOSIS) IN WHOM&#xD;
        THE TOTAL AMOUNT OF PROTOCOL RELATED BLOOD WILL NOT EXCEED 8 ML.&#xD;
&#xD;
          1. Males or females of age greater than or equal to 18 years old.&#xD;
&#xD;
          2. Subjects unable to provide informed consent must have a surrogate decision maker or&#xD;
             another legally authorized representative (such as a legal guardian or holder of the&#xD;
             DPA)&#xD;
&#xD;
        EXCLUSION CRITERIA FOR SUBJECTS WHO ARE TO RECEIVE CRRT (IRRESPECTIVE OF DIAGNOSIS) IN WHOM&#xD;
        THE TOTAL AMOUNT OF PROTOCOL RELATED BLOOD WILL NOT EXCEED 8 ML)&#xD;
&#xD;
          1. Hemoglobin &lt;7.0 g/dL&#xD;
&#xD;
          2. In the presence of known coronary artery disease (CAD) a systolic blood pressure (SBP)&#xD;
             &lt;90 mmHg. In the absence of known CAD a SBP &lt;80 mmHg or mean arterial pressure (MAP)&#xD;
             &lt;60 mmHg.&#xD;
&#xD;
        INCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:&#xD;
&#xD;
          1. Males or females of age greater than or equal to 18 years old&#xD;
&#xD;
          2. Must be able to provide informed, written consent.&#xD;
&#xD;
        EXCLUSION CRITERIA FOR HEATLHY VOLUNTEERS:&#xD;
&#xD;
          1. Blood or platelet donation within the last 6 weeks.&#xD;
&#xD;
          2. Hemoglobin below normal (e.g. below 11.2 g/dl for females and below 13.7 mg/dl for&#xD;
             males at the NIH CC); subjects may return for evaluation at a later date. (After&#xD;
             initial enrollment, hematocrit does not need to be done prior to subsequent blood&#xD;
             draws unless there is interval development of symptomatic anemia)&#xD;
&#xD;
          3. History of recreational drug use with the exception of marijuana (as long as marijuana&#xD;
             use was &gt;3 months from the time of study screening).&#xD;
&#xD;
          4. Active acute illness (i.e viral syndrome). Subjects may return for evaluation at a&#xD;
             later date once the acute illness resolves.&#xD;
&#xD;
          5. Volunteers may be excluded if in the opinion of the study investigators they have a&#xD;
             condition that may adversely affect the outcome of the study or the safety of the&#xD;
             volunteer, such as, active tobacco use (&gt; 6 months) in the past ten years, any tobacco&#xD;
             use within 3 months prior to the screening evaluation, a history of clinically&#xD;
             relevant and active cardiopulmonary disease (e.g. Including but not limited to any&#xD;
             cardiopulmonary diseases not well controlled by medications, EKG with evidence of&#xD;
             clinically relevant heart disease, COPD with hypoxemia and forced expiratory&#xD;
             volume/forced vital capacity (FEV1/FVC) &gt; 2 standard deviations from normal, etc.).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael A Solomon, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Institutes of Health Clinical Center (CC)</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Grace M Graninger, R.N.</last_name>
    <phone>(301) 496-9320</phone>
    <email>ggraninger@cc.nih.gov</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Michael A Solomon, M.D.</last_name>
    <phone>(301) 496-9320</phone>
    <email>msolomon@cc.nih.gov</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>National Institutes of Health Clinical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)</last_name>
      <phone>800-411-1222</phone>
      <phone_ext>TTY8664111010</phone_ext>
      <email>prpl@cc.nih.gov</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2017-CC-0148.html</url>
    <description>NIH Clinical Center Detailed Web Page</description>
  </link>
  <reference>
    <citation>Lewis GD, Ngo D, Hemnes AR, Farrell L, Domos C, Pappagianopoulos PP, Dhakal BP, Souza A, Shi X, Pugh ME, Beloiartsev A, Sinha S, Clish CB, Gerszten RE. Metabolic Profiling of Right Ventricular-Pulmonary Vascular Function Reveals Circulating Biomarkers of Pulmonary Hypertension. J Am Coll Cardiol. 2016 Jan 19;67(2):174-189. doi: 10.1016/j.jacc.2015.10.072.</citation>
    <PMID>26791065</PMID>
  </reference>
  <reference>
    <citation>Li H, Tu H, Wang Y, Levine M. Vitamin C in mouse and human red blood cells: an HPLC assay. Anal Biochem. 2012 Jul 15;426(2):109-17. doi: 10.1016/j.ab.2012.04.014. Epub 2012 Apr 20.</citation>
    <PMID>22522059</PMID>
  </reference>
  <reference>
    <citation>Quintana-Bustamante O, Segovia JC. Generation of Patient-Specific induced Pluripotent Stem Cell from Peripheral Blood Mononuclear Cells by Sendai Reprogramming Vectors. Methods Mol Biol. 2016;1353:1-11. doi: 10.1007/7651_2014_170.</citation>
    <PMID>25523810</PMID>
  </reference>
  <verification_date>June 29, 2023</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>July 6, 2023</last_update_submitted>
  <last_update_submitted_qc>July 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Assay Development</keyword>
  <keyword>Gene Expression</keyword>
  <keyword>Metabolomics</keyword>
  <keyword>Induced Pluripotent Stem Cells</keyword>
  <keyword>PBMCs/DNA/RNA</keyword>
  <keyword>Natural History</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vascular Diseases</mesh_term>
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03253705
org study id: 170148
secondary id: 17-CC-0148
nct id: NCT03253705
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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 or urine. Blood samples may also be collected to make special cells. These are called
      induced pluripotent stem cells or iPSCs. Pluripotent stem cells are cells that can be
      converted into any type of cell. Researchers want to study in the lab iPSCs that are derived
      from blood samples.

      Objective:

      To collect samples to help study genes, proteins, sugars, fats, vitamins, and other
      metabolites found in blood or urine.

      Eligibility:

      Healthy volunteers and patients ages 18 and older

      Design:

      First-time research study participants at NIH will have an initial visit for this study that
      should last no more than 1 hour. All other visits should last 20 30 minutes.

      Participants will undergo a limited history and physical exam.

      Participants may have routine blood and urine tests.

      If participants are giving a blood sample, they must have a hemoglobin level checked in the
      past 12 months to make sure it is safe for them to give a blood sample for research.

      Participants may have a venous blood collection. They may do this at several visits. They
      will lie on a recliner or couch or sit in a chair. A needle will be placed into a vein in the
      hand or arm, using sterile techniques. Blood will be withdrawn into multiple syringes or
      tubes.

      Participants may be asked to provide urine in an appropriate container...
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) and other pulmonary vascular diseases, arteriosclerosis, transplantation,
      inflammatory processes and sepsis. The collection of human blood and urine from both research
      subjects and healthy volunteers is necessary for the development of relevant laboratory
      assays and protocols, and to further research studies requiring such evaluations. In research
      subjects undergoing renal replacement therapy who produce limited urine we may also sample
      ultrafiltrate as a surrogate for urine. This protocol defines in general terms the purposes
      for which blood, urine and ultrafiltrate will be collected by members of the NIH s Clinical
      Center (CC), Critical Care Medicine Department (CCMD) and collaborating institutions and
      establishes general conditions under which sampling will be performed.
observational model: Other
time perspective: Other
measure: Exploratory assay development
time frame: 10 years
description: Development of new assays
arm group label: Controls
description: Healthy Controls
arm group label: Research Subjects
description: Research Subjects already enrolled on other NIH protocols
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Michael A Solomon, M.D.
role: Principal Investigator
affiliation: National Institutes of Health Clinical Center (CC)
last name: Grace M Graninger, R.N.
phone: (301) 496-9320
email: ggraninger@cc.nih.gov
last name: Michael A Solomon, M.D.
phone: (301) 496-9320
email: msolomon@cc.nih.gov
facility: 
status: Recruiting
contact: 
country: United States
url: https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2017-CC-0148.html
description: NIH Clinical Center Detailed Web Page
citation: Lewis GD, Ngo D, Hemnes AR, Farrell L, Domos C, Pappagianopoulos PP, Dhakal BP, Souza A, Shi X, Pugh ME, Beloiartsev A, Sinha S, Clish CB, Gerszten RE. Metabolic Profiling of Right Ventricular-Pulmonary Vascular Function Reveals Circulating Biomarkers of Pulmonary Hypertension. J Am Coll Cardiol. 2016 Jan 19;67(2):174-189. doi: 10.1016/j.jacc.2015.10.072.
PMID: 26791065
citation: Li H, Tu H, Wang Y, Levine M. Vitamin C in mouse and human red blood cells: an HPLC assay. Anal Biochem. 2012 Jul 15;426(2):109-17. doi: 10.1016/j.ab.2012.04.014. Epub 2012 Apr 20.
PMID: 22522059
citation: Quintana-Bustamante O, Segovia JC. Generation of Patient-Specific induced Pluripotent Stem Cell from Peripheral Blood Mononuclear Cells by Sendai Reprogramming Vectors. Methods Mol Biol. 2016;1353:1-11. doi: 10.1007/7651_2014_170.
PMID: 25523810
responsible party type: Sponsor
mesh term: Vascular Diseases
mesh term: Inflammation