xml: <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/NCT05992012</url>
    </required_header>
    <id_info>
      <org_study_id>CVAG.MINTOR2.7AUG23</org_study_id>
      <nct_id>NCT05992012</nct_id>
    </id_info>
    <brief_title>Myocardial Infarction Triggers and Onset in Jordan Study 2</brief_title>
    <acronym>MINTOR 2</acronym>
    <official_title>Myocardial Infarction Triggers and Onset in Jordan Study (MINTOR) 2</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Jordan Collaborating Cardiology Group</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Jordan Collaborating Cardiology Group</source>
    <oversight_info>
      <has_dmc>No</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>
        A previous study (MINTOR 1) found that 43% of ST elevation myocardial infarction (STEMI)&#xD;
        patients in Jordan had a triggering events. Fifteen years later, with changing demographics&#xD;
        and in the post covid-19 time, we believe that triggered acute myocardial infarction might&#xD;
        have changed in incidence and nature of the triggering events.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The onset of acute ST elevation myocardial infarction (STEMI) is a complex interplay of&#xD;
        internal circadian factors and external physical and emotional triggers. These interactions&#xD;
        may lead to rupture of an often nonocclusive vulnerable atherosclerotic coronary plaque with&#xD;
        subsequent formation of an occlusive thrombus. The onset of MI has a distinct pattern, with&#xD;
        peak incidence within the first few hours after awakening, on certain days of the week, and&#xD;
        in the winter months. Physical and emotional stresses are important triggers of acute&#xD;
        cardiovascular events including MI. Triggering events, internal changes, and external factors&#xD;
        vary among different geographical, environmental, and ethnic regions. Life-style changes,&#xD;
        pharmacotherapy, and psychologic interventions may potentially modify the response to, and&#xD;
        protect against the effects of triggering events.&#xD;
  &#xD;
        MINTOR 1 showed that 43% of 900+ Jordanians with STEMI were exposed to a physical or&#xD;
        emotional triggers before the onset of the heart attack. It was also found that Friday was&#xD;
        the day of the week that witnessed more MIs that other days of the week and that 55% of MIs&#xD;
        occurred in the early morning hours.&#xD;
  &#xD;
        It is largely unknown if the frequency and types of triggers, onset time of MI, day with peak&#xD;
        of MI incidence have changed over time in Jordan with changing population demographics,&#xD;
        especially in the post Covid-19 times. These patients will be followed up for 3 years for&#xD;
        occurring of incident vascular events.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">January 2026</completion_date>
    <primary_completion_date type="Anticipated">October 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>3 Years</target_duration>
    <primary_outcome>
      <measure>Triggers of acute myocardial infarction</measure>
      <time_frame>From date of study enrollment until the date of a documented exposure to a trigger, up to the time of discharge from the hospital (2-5 days).</time_frame>
      <description>Exposure to emotional of physical triggering events before the occurrence of the heart attack</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Time of onset of acute myocardial infarction</measure>
      <time_frame>From date of study enrollment until the date of documenting the day and hour of onset of the heart attach, up to the time of discharge from the hospital (2-5 days)</time_frame>
      <description>Documenting the time of onset of the chest pain that marks the onset of the myocardial infarction (expressed as day of the week (MONDAY to SUNDAY) and time of the day (00:00 hr to 24:00 hr).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acute cardiovascular events</measure>
      <time_frame>From date of study enrollment until the date of occurrence of the first cardiovascular event (described above) up to three years after study enrollment.</time_frame>
      <description>Occurrence of death from any cause, myocardial infarction, stroke, heart failure, repeat coronary revascularization (percutaneous or surgical).</description>
    </primary_outcome>
    <enrollment type="Anticipated">1000</enrollment>
    <condition>Triggers of Acute Myocardial Infarction</condition>
    <condition>Time of Onset of Acute Myocardial Infarction</condition>
    <condition>Long-term Prognosis After Acute Myocardial Infarction</condition>
    <eligibility>
      <study_pop>
        <textblock>
          All adults aged 18 years and above admitted with a diagnosis of acute ST elevation&#xD;
          myocardial infarction will be asked about the potential presence of a triggering event&#xD;
          prior to the heart attack as well the exact timing (hour of the day and the day of the&#xD;
          week) when the pain of the heart attack started.&#xD;
  &#xD;
          Furthermore these patients will be followed up for 3 years to study the occurrence of&#xD;
          future cardiovascular event at 3 years. These events include all-cause death, myocardial&#xD;
          infarction, stroke, heart failure and repeat coronary revascularization (percutaneous of&#xD;
          surgical).&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 18 years and above.&#xD;
  &#xD;
            -  Documented acute ST elevation myocardial infarction.&#xD;
  &#xD;
            -  Willing to sign an informed consent.&#xD;
  &#xD;
            -  Available contact numbers for a 3-year follow up&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Unwilling to sign an informed consent.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Daria Jaara, MD</last_name>
      <role>Study Director</role>
      <affiliation>Istishari Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ayman Hammoudeh, MD, FACC</last_name>
      <phone>0096265001000</phone>
      <phone_ext>266</phone_ext>
      <email>a.hammoudeh@istisharihospital.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Mohammad Bahhour, MD</last_name>
      <phone>0096265001000</phone>
      <phone_ext>267</phone_ext>
      <email>researchculture2020@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Istishari Hospital</name>
        <address>
          <city>Amman</city>
          <zip>11888</zip>
          <country>Jordan</country>
        </address>
      </facility>
      <contact>
        <last_name>Ayman Hammoudeh, MD FACC</last_name>
        <phone>0096265001000</phone>
        <phone_ext>266</phone_ext>
        <email>a.hammoudeh@istisharihospital.com</email>
      </contact>
      <contact_backup>
        <last_name>Mohamad Jumaa, MD</last_name>
        <phone>00962795222802</phone>
        <email>hammoudeh_ayman@yahoo.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Jordan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Acute myocardial infarction</keyword>
    <keyword>Acute ST-segment elevation myocardial infarction</keyword>
    <keyword>Triggers of acute myocardial infarction</keyword>
    <keyword>Middle East</keyword>
    <keyword>Prognosis</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>Will send e mails to other tertiary care institutions inviting them to participate in the study</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>Immediately after the date of securing an NCT unique number, up to 6 months after that date.</ipd_time_frame>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05992012
  org study id: CVAG.MINTOR2.7AUG23
  nct id: NCT05992012
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  A previous study (MINTOR 1) found that 43% of ST elevation myocardial infarction (STEMI)
        patients in Jordan had a triggering events. Fifteen years later, with changing demographics
        and in the post covid-19 time, we believe that triggered acute myocardial infarction might
        have changed in incidence and nature of the triggering events.
  The onset of acute ST elevation myocardial infarction (STEMI) is a complex interplay of
        internal circadian factors and external physical and emotional triggers. These interactions
        may lead to rupture of an often nonocclusive vulnerable atherosclerotic coronary plaque with
        subsequent formation of an occlusive thrombus. The onset of MI has a distinct pattern, with
        peak incidence within the first few hours after awakening, on certain days of the week, and
        in the winter months. Physical and emotional stresses are important triggers of acute
        cardiovascular events including MI. Triggering events, internal changes, and external factors
        vary among different geographical, environmental, and ethnic regions. Life-style changes,
        pharmacotherapy, and psychologic interventions may potentially modify the response to, and
        protect against the effects of triggering events.
  
        MINTOR 1 showed that 43% of 900+ Jordanians with STEMI were exposed to a physical or
        emotional triggers before the onset of the heart attack. It was also found that Friday was
        the day of the week that witnessed more MIs that other days of the week and that 55% of MIs
        occurred in the early morning hours.
  
        It is largely unknown if the frequency and types of triggers, onset time of MI, day with peak
        of MI incidence have changed over time in Jordan with changing population demographics,
        especially in the post Covid-19 times. These patients will be followed up for 3 years for
        occurring of incident vascular events.
  observational model: Cohort
  time perspective: Prospective
  measure: Triggers of acute myocardial infarction
  time frame: From date of study enrollment until the date of a documented exposure to a trigger, up to the time of discharge from the hospital (2-5 days).
  description: Exposure to emotional of physical triggering events before the occurrence of the heart attack
  measure: Time of onset of acute myocardial infarction
  time frame: From date of study enrollment until the date of documenting the day and hour of onset of the heart attach, up to the time of discharge from the hospital (2-5 days)
  description: Documenting the time of onset of the chest pain that marks the onset of the myocardial infarction (expressed as day of the week (MONDAY to SUNDAY) and time of the day (00:00 hr to 24:00 hr).
  measure: Acute cardiovascular events
  time frame: From date of study enrollment until the date of occurrence of the first cardiovascular event (described above) up to three years after study enrollment.
  description: Occurrence of death from any cause, myocardial infarction, stroke, heart failure, repeat coronary revascularization (percutaneous or surgical).
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Daria Jaara, MD
  role: Study Director
  affiliation: Istishari Hospital
  last name: Ayman Hammoudeh, MD, FACC
  phone: 0096265001000
  phone ext: 266
  email: a.hammoudeh@istisharihospital.com
  last name: Mohammad Bahhour, MD
  phone: 0096265001000
  phone ext: 267
  email: researchculture2020@gmail.com
  facility: 
  contact: 
  contact backup: 
  country: Jordan
  responsible party type: Sponsor
  mesh term: Myocardial Infarction
  mesh term: Infarction
  sharing ipd: Yes
  ipd description: Will send e mails to other tertiary care institutions inviting them to participate in the study
  ipd info type: Study Protocol
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: Immediately after the date of securing an NCT unique number, up to 6 months after that date.