<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/NCT03022552</url>
  </required_header>
  <id_info>
    <org_study_id>16-01104-3</org_study_id>
    <nct_id>NCT03022552</nct_id>
  </id_info>
  <brief_title>Heart Attack Research Program: Platelet Sub-Study (HARP)</brief_title>
  <acronym>HARP</acronym>
  <official_title>Heart Attack Research Program: Platelet Sub-Study (HARP); Platelet Collection for Patients With Myocardial Infarction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NYU Langone Health</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This prospective observational cohort study, will investigate the platelet phenotype,&#xD;
      platelet genetic composition, and role of platelets as effector cells in women and men with&#xD;
      myocardial infarction (MINOCA or MI-CAD) and controls. This study, which will take place at&#xD;
      NYU and Bellevue Medical Center, and participating external sites. May have concurrent&#xD;
      enrollment with the HARP Main Imaging (NCT02914483). Additionally, a sex, group of age and&#xD;
      race matched disease controls 'CATH-NOCA' composed of women and men with stable angina&#xD;
      referred for cardiac catheterization, will be enrolled. Blood obtained during the initial&#xD;
      catheterization and 2 months post-MI will be utilized for platelet testing.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2025</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>6 Months</target_duration>
  <primary_outcome>
    <measure>Examination of Platelet Activity Markers</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Examination of Markers of Cardiovascular Disease Risk</measure>
    <time_frame>1 year</time_frame>
    <description>This will include additional examination of known thrombosis, Inflammation, metabolic disease, and lipids/lipoprotein markers.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cellular and molecular mechanism of myocardial infarction in women</measure>
    <time_frame>1 year</time_frame>
    <description>To further investigate this mechanism, recent advances in microRNA, RNA, DNA expression profiling, and plasma and serum collections will be used.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Examination of non-coding and coding mRNA profiles in women with MI and matched controls</measure>
    <time_frame>4 years</time_frame>
    <description>Specific transcripts associated with platelet activation, plaque destabilization, and different cardiovascular diseases will be analyzed at the genetic level.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">350</enrollment>
  <condition>Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>MINOCA</arm_group_label>
    <description>Women with myocardial infarction (MI) with demonstrated non-obstructive coronary artery disease during cardiac catheterization (less than 50% blockage in any major vessel).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MI-CAD</arm_group_label>
    <description>Women with myocardial infarction (MI) with demonstrated obstructive coronary artery disease during cardiac catheterization (50% or greater blockage in any major vessel) or previous history of percutaneous coronary intervention (PCI) or or coronary artery bypass graft (CABG).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CATH-NOCA</arm_group_label>
    <description>Women with stable angina that are age and race matched to women in the MINOCA arm that are clinically referred for cardiac catheterization</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood Collection&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        This study may have concurrent enrollment with the HARP Main Imaging (NCT02905357). This&#xD;
        study population includes women and men who present to the hospital with an MI, with&#xD;
        non-obstructive coronary artery disease or obstructive artery disease, are eligible for&#xD;
        blood collection. Additionally, a sex, group of age and race matched disease controls&#xD;
        'CATH-NOCA' will be composed of women and men with stable angina referred for cardiac&#xD;
        catheterization.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Acute ischemic symptoms compatible with diagnosis of MI, such as chest pain or anginal&#xD;
             equivalent symptoms at rest or new onset exertional anginal equivalent symptoms&#xD;
&#xD;
          -  Objective evidence of MI (either or both of the following):&#xD;
&#xD;
               -  Elevation of troponin to above the laboratory upper limit of normal (ULN)&#xD;
&#xD;
               -  ST segment elevation of ≥1mm on 2 contiguous ECG leads&#xD;
&#xD;
          -  Willing to provide informed consent and comply with all aspects of the protocol&#xD;
&#xD;
          -  Administration of aspirin at least 1 hour before cardiac catheterization&#xD;
&#xD;
          -  Administration of thienopyridine (e.g., clopidogrel, ticagrelor) at least 1 hour&#xD;
             before cardiac catheterization&#xD;
&#xD;
          -  Women and men with ≥50% of any major epicardial vessel on invasive angiography may&#xD;
             participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Recent use of vasospastic agents, such as cocaine, triptans, or ergot alkaloids (≤1&#xD;
             month)&#xD;
&#xD;
          -  Alternate explanation for troponin elevation, such as hypertensive urgency, acute&#xD;
             exacerbation of heart failure, chronic elevation due to kidney disease, pulmonary&#xD;
             embolism, cardiac trauma&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Thrombolytic therapy for STEMI (qualifying event)&#xD;
&#xD;
          -  Use of any of the following medications:&#xD;
&#xD;
          -  Platelet antagonists (except aspirin and thienopyridines) within 7 days&#xD;
&#xD;
          -  NSAIDs (e.g., ibuprofen, naproxen) within 3 days.&#xD;
&#xD;
          -  Thrombocytopenia (platelet count &lt;100,000)&#xD;
&#xD;
          -  Thrombocytosis (platelet count &gt;500,000)&#xD;
&#xD;
          -  Anemia (hemoglobin &lt;9 mg/dl)&#xD;
&#xD;
          -  Hemorrhagic diathesis&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Harmony R Reynolds, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jeffrey Berger, MD</last_name>
    <phone>212 263 4004</phone>
    <email>jeffrey.berger@nyumc.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Harmony R Reynolds, MD</last_name>
    <phone>646-501-0302</phone>
    <email>harmony.reynolds@nyumc.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>NYU Langone Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jeffrey Berger, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <last_update_submitted>May 23, 2023</last_update_submitted>
  <last_update_submitted_qc>May 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Myocardial Infarction</keyword>
  <keyword>Platelets</keyword>
  <keyword>Blood Collection</keyword>
  <keyword>Genomics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified data will be shared after the end of the study.</ipd_description>
  </patient_data>
  <!-- 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/NCT03022552
org study id: 16-01104-3
nct id: NCT03022552
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This prospective observational cohort study, will investigate the platelet phenotype,
      platelet genetic composition, and role of platelets as effector cells in women and men with
      myocardial infarction (MINOCA or MI-CAD) and controls. This study, which will take place at
      NYU and Bellevue Medical Center, and participating external sites. May have concurrent
      enrollment with the HARP Main Imaging (NCT02914483). Additionally, a sex, group of age and
      race matched disease controls 'CATH-NOCA' composed of women and men with stable angina
      referred for cardiac catheterization, will be enrolled. Blood obtained during the initial
      catheterization and 2 months post-MI will be utilized for platelet testing.
observational model: Cohort
time perspective: Prospective
measure: Examination of Platelet Activity Markers
time frame: 1 year
measure: Examination of Markers of Cardiovascular Disease Risk
time frame: 1 year
description: This will include additional examination of known thrombosis, Inflammation, metabolic disease, and lipids/lipoprotein markers.
measure: Cellular and molecular mechanism of myocardial infarction in women
time frame: 1 year
description: To further investigate this mechanism, recent advances in microRNA, RNA, DNA expression profiling, and plasma and serum collections will be used.
measure: Examination of non-coding and coding mRNA profiles in women with MI and matched controls
time frame: 4 years
description: Specific transcripts associated with platelet activation, plaque destabilization, and different cardiovascular diseases will be analyzed at the genetic level.
arm group label: MINOCA
description: Women with myocardial infarction (MI) with demonstrated non-obstructive coronary artery disease during cardiac catheterization (less than 50% blockage in any major vessel).
arm group label: MI-CAD
description: Women with myocardial infarction (MI) with demonstrated obstructive coronary artery disease during cardiac catheterization (50% or greater blockage in any major vessel) or previous history of percutaneous coronary intervention (PCI) or or coronary artery bypass graft (CABG).
arm group label: CATH-NOCA
description: Women with stable angina that are age and race matched to women in the MINOCA arm that are clinically referred for cardiac catheterization
Blood Collection
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 21 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Harmony R Reynolds, MD
role: Principal Investigator
affiliation: NYU Langone Medical Center
last name: Jeffrey Berger, MD
phone: 212 263 4004
email: jeffrey.berger@nyumc.org
last name: Harmony R Reynolds, MD
phone: 646-501-0302
email: harmony.reynolds@nyumc.org
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Myocardial Infarction
mesh term: Infarction
sharing ipd: Yes
ipd description: De-identified data will be shared after the end of the study.