<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/NCT04430374</url>
  </required_header>
  <id_info>
    <org_study_id>MRC-05-113</org_study_id>
    <nct_id>NCT04430374</nct_id>
  </id_info>
  <brief_title>Registry for a Cardiovascular Patient Who COVID-19 Infection in Qatar and Gulf</brief_title>
  <official_title>Qatar Cardiovascular COVID-19 Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hamad Medical Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hamad Medical Corporation</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>
      The novel coronavirus, severe acute respiratory syndrome coronavirus 2, that causes&#xD;
      coronavirus disease 2019 (COVID -19), is highly contagious in the community and has resulted&#xD;
      in a global pandemic. This infection has a special implication on the patient who complains&#xD;
      from cardiac disease or acute cardiovascular condition and may result in cardiovascular&#xD;
      complications such as myocardial infarction. For this end, we target to study this group of&#xD;
      patient, who has a cardiac disease with COVID-19 in Qatar, in addition, the acute myocardial&#xD;
      infarction with COVID-19 from the Gulf countries and collect all the related data to come&#xD;
      with a comprehensive view about those patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of this registry is to create a database of patients who present with&#xD;
      acute cardiovascular and are found to be COVID -19 positive (by PCR). The registry will&#xD;
      consist of four arms (1) Retrospective data for all patients since the COVID-19 appear in&#xD;
      Qatar unit the date of submission the protocol (2) Prospective data starting from the date of&#xD;
      submission of this protocol and forward until end of December 2020 (3) Retrospective data for&#xD;
      all cardiac patients hospitalizations in the COVID period of this year 2020 will be compared&#xD;
      to previous years to report the trends of acute cardiovascular conditions in the COVID era to&#xD;
      previous data, as a lot of countries documented decrease in the incidence. (4) retrospective&#xD;
      data for acute MI and found to be COVID-19 until this protocol amendment from participating&#xD;
      hospitals in the Gulf region to be compared with Acute MI from Qatar who collected in arm 1.&#xD;
      The registry will consist of patients admitted with AMI who were already having active&#xD;
      COVID-19 infection or were incidentally found to have COVID-19 by PCR. Additionally,&#xD;
      prospective data from the data of this protocol amendment until the end of December 2020.&#xD;
      This arm target to (a) increases the number of the collected patient for Acute MI with&#xD;
      COVID-19category due to the small number in Qatar alone. (b) give the opportunity for Qatar&#xD;
      to lead a multicenter project to serve in a hot topic, in particular, the data collection and&#xD;
      analysis will be in Qatar. (c) allow releasing a publication for one cardiovascular center&#xD;
      (Qatar only) and multi-cardiovascular center (all the Gulf), a multi-center publication about&#xD;
      this issue could be rare on the worldwide level, and finally, (d) to increase the accuracy of&#xD;
      the data analysis due to larger data size and comparing more than one site together.&#xD;
&#xD;
      Secondary plan to compare our patients' populations and outcomes with that of other&#xD;
      international registries such as the NACMI(US registry). The NACMI registry is a rapid&#xD;
      collaboration of multinational societies and medical institutions with a pragmatic study&#xD;
      design to encourage widespread participation that will enable the development of data-driven&#xD;
      guidelines and therapies.&#xD;
&#xD;
      The subject will be patients with confirmed or suspected COVID -19 infection with the acute&#xD;
      cardiovascular conditions at the time of presentation to the hospital or that developed while&#xD;
      in the hospital. All the history, laboratory results, current admission data, medication,&#xD;
      angiogram, or intervention procedure (if underwent), and any other relevant data will be&#xD;
      collected. All the patients who are applicable for this registry and meet the inclusion&#xD;
      criteria will be involved so the final number of the subject is not specified. All patients&#xD;
      with the acute coronary syndrome, out of hospital cardiac arrest and arrhythmias who are&#xD;
      found to be COVID positive and required hospitalization will be included.&#xD;
&#xD;
      The following data variables will be collected as covariates of interest: baseline&#xD;
      demographic and clinical characteristics, laboratory data, and pattern of ST-segment&#xD;
      elevation (diffuse, focal, with or without ST-segment depression and/or PR -segment&#xD;
      depression) transthoracic echocardiography or point-of-care ultrasound findings, commonly&#xD;
      used time to treatment metrics in STEMI care (door -to -balloon or door -to -needle times),&#xD;
      angiographic characteristics, and adjunctive pharmacological and device therapies including&#xD;
      mechanical circulatory support (MCS ).&#xD;
&#xD;
      Implications for COVID -19 positive patients Observational registries have gained traction in&#xD;
      cardiovascular medicine as they provide important information, including benefits and&#xD;
      potential complications of different treatments or procedures. [12] For example, consecutive&#xD;
      enrollment of patients with well -defined entry criteria in the Chest pain -MI Registry has&#xD;
      been a reliable source for outcome-based, a quality improvement on high -risk STEMI/NSTEMI&#xD;
      patients. [13] Immediate access to actionable data is particularly relevant to the current&#xD;
      expanding COVID -19 pandemic which is disproportionally affecting cardiovascular patients and&#xD;
      healthcare workers. [14] At present, there is no data-driven consensus on the management of&#xD;
      patients with confirmed or suspected COVID -19 infection who present with ST-segment&#xD;
      elevation on ECG. [11,15,16] The NACMI registry will be beneficial in identifying etiology,&#xD;
      patterns of myocardial injury, developing a risk model for cardiac complications,&#xD;
      understanding short and long -term major adverse cardiac events, and designing clinical&#xD;
      trials testing different treatment modalities. Therefore, the registry will include both&#xD;
      COVID -19 positive patients and PUI with acute cardiovascular conditions. A comparison of PUI&#xD;
      subsequently confirmed positive to those subsequently confirmed negative will provide a&#xD;
      unique insight into the pathophysiologic mechanism of STEMI from COVID -19, including&#xD;
      myocarditis and prothrombotic states. Comparison of patients enrolled in NACMI to&#xD;
      propensity-matched non -COVID STEMI controls for 1 year prior will provide critical&#xD;
      information regarding etiology, treatment strategies and clinical outcomes in the COVID -19&#xD;
      pandemic. As testing for COVID -19 becomes more rapid, this decision -making process is&#xD;
      expected to evolve. Additionally, it has been reported that overall STEMI volumes have&#xD;
      decreased in the COVID -19 era, without a clear understanding of the reasons. [17,18] It may&#xD;
      be that patients are delaying their presentation to the hospital, potentially leading to the&#xD;
      need for mechanical circulatory support in the acute setting, mechanical complications of&#xD;
      STEMI, sudden death or an increased heart failure population. Additionally, if patients are&#xD;
      presenting later in their clinical course, NACMI registry data will allow practitioners to&#xD;
      improve care models to improve time to treatment in this unique era.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 2, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</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>Other</time_perspective>
  </study_design_info>
  <target_duration>1 Week</target_duration>
  <primary_outcome>
    <measure>The impact of COVID-19 on cardiovascular patient</measure>
    <time_frame>2 month from starting date</time_frame>
    <description>The outcome of this registry will be:&#xD;
entire information about the patients who admitted with COVID-19 accompany with a cardiovascular condition in Qatar.&#xD;
Additionally, a comparison will be conducted between the cardiac patient who admitted over the period February to December to December 2020 and the same category of patients over the same period of 2019 in Qatar to figure out the reason behind the dropping of the number of the patient.&#xD;
A multicenter data from the Gulf countries for Acute MI patients infected with COVID-19.&#xD;
A comparison between our patients (either in Qatar only or the entire Gulf) populations and the outcome of other international registries such as the NACMI (US registry)</description>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No interverntion</intervention_name>
    <description>No intervention will be done, registry only</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        (1) Retrospective data for all patients since the COVID-19 appear in Qatar unit the&#xD;
        prospective arm gets started after approval(2) Prospective data starting from the date of&#xD;
        submission of this protocol and forward and all patients will be followed up for long-term&#xD;
        outcome(3) Retrospective data for all cardiac patients hospitalizations in the COVID period&#xD;
        of this year 2020 will be compared to previous years to report the trends of acute&#xD;
        cardiovascular conditions in the COVID era to previous data, as a lot of countries&#xD;
        documented decrease in the incidence.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients who admitted to the heart hospital or any other hospital with acute&#xD;
             cardiovascular condition.&#xD;
&#xD;
          2. Patient with confirming or suspicious of COVID-19 infection&#xD;
&#xD;
          3. Patient who admitted to any hospital in the Gulf and has Acute MI with confirm or&#xD;
             suspicious of COVID-19 infection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  N/A&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr.Jassim Alsuwaidi Senior Consultant</last_name>
    <role>Principal Investigator</role>
    <affiliation>HMC</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>MRC</last_name>
    <phone>44396168</phone>
    <email>MRC@hamad.qa</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hamad Medical Corporation</name>
      <address>
        <city>Doha</city>
        <state>Unlisted (UL)</state>
        <zip>974</zip>
        <country>Qatar</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>DR.Jassim Alsuwaidi Senior Consultant</last_name>
      <phone>44395392</phone>
      <email>jalsuwaidi@hamad.qa</email>
    </contact>
  </location>
  <location_countries>
    <country>Qatar</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>June 24, 2020</last_update_submitted>
  <last_update_submitted_qc>June 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hamad Medical Corporation</investigator_affiliation>
    <investigator_full_name>Dr. JASSIM MOHD. AL SUWAIDI</investigator_full_name>
    <investigator_title>Senior Cardiologist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</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/NCT04430374
org study id: MRC-05-113
nct id: NCT04430374
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The novel coronavirus, severe acute respiratory syndrome coronavirus 2, that causes
      coronavirus disease 2019 (COVID -19), is highly contagious in the community and has resulted
      in a global pandemic. This infection has a special implication on the patient who complains
      from cardiac disease or acute cardiovascular condition and may result in cardiovascular
      complications such as myocardial infarction. For this end, we target to study this group of
      patient, who has a cardiac disease with COVID-19 in Qatar, in addition, the acute myocardial
      infarction with COVID-19 from the Gulf countries and collect all the related data to come
      with a comprehensive view about those patients.
The primary objective of this registry is to create a database of patients who present with
      acute cardiovascular and are found to be COVID -19 positive (by PCR). The registry will
      consist of four arms (1) Retrospective data for all patients since the COVID-19 appear in
      Qatar unit the date of submission the protocol (2) Prospective data starting from the date of
      submission of this protocol and forward until end of December 2020 (3) Retrospective data for
      all cardiac patients hospitalizations in the COVID period of this year 2020 will be compared
      to previous years to report the trends of acute cardiovascular conditions in the COVID era to
      previous data, as a lot of countries documented decrease in the incidence. (4) retrospective
      data for acute MI and found to be COVID-19 until this protocol amendment from participating
      hospitals in the Gulf region to be compared with Acute MI from Qatar who collected in arm 1.
      The registry will consist of patients admitted with AMI who were already having active
      COVID-19 infection or were incidentally found to have COVID-19 by PCR. Additionally,
      prospective data from the data of this protocol amendment until the end of December 2020.
      This arm target to (a) increases the number of the collected patient for Acute MI with
      COVID-19category due to the small number in Qatar alone. (b) give the opportunity for Qatar
      to lead a multicenter project to serve in a hot topic, in particular, the data collection and
      analysis will be in Qatar. (c) allow releasing a publication for one cardiovascular center
      (Qatar only) and multi-cardiovascular center (all the Gulf), a multi-center publication about
      this issue could be rare on the worldwide level, and finally, (d) to increase the accuracy of
      the data analysis due to larger data size and comparing more than one site together.

      Secondary plan to compare our patients' populations and outcomes with that of other
      international registries such as the NACMI(US registry). The NACMI registry is a rapid
      collaboration of multinational societies and medical institutions with a pragmatic study
      design to encourage widespread participation that will enable the development of data-driven
      guidelines and therapies.

      The subject will be patients with confirmed or suspected COVID -19 infection with the acute
      cardiovascular conditions at the time of presentation to the hospital or that developed while
      in the hospital. All the history, laboratory results, current admission data, medication,
      angiogram, or intervention procedure (if underwent), and any other relevant data will be
      collected. All the patients who are applicable for this registry and meet the inclusion
      criteria will be involved so the final number of the subject is not specified. All patients
      with the acute coronary syndrome, out of hospital cardiac arrest and arrhythmias who are
      found to be COVID positive and required hospitalization will be included.

      The following data variables will be collected as covariates of interest: baseline
      demographic and clinical characteristics, laboratory data, and pattern of ST-segment
      elevation (diffuse, focal, with or without ST-segment depression and/or PR -segment
      depression) transthoracic echocardiography or point-of-care ultrasound findings, commonly
      used time to treatment metrics in STEMI care (door -to -balloon or door -to -needle times),
      angiographic characteristics, and adjunctive pharmacological and device therapies including
      mechanical circulatory support (MCS ).

      Implications for COVID -19 positive patients Observational registries have gained traction in
      cardiovascular medicine as they provide important information, including benefits and
      potential complications of different treatments or procedures. [12] For example, consecutive
      enrollment of patients with well -defined entry criteria in the Chest pain -MI Registry has
      been a reliable source for outcome-based, a quality improvement on high -risk STEMI/NSTEMI
      patients. [13] Immediate access to actionable data is particularly relevant to the current
      expanding COVID -19 pandemic which is disproportionally affecting cardiovascular patients and
      healthcare workers. [14] At present, there is no data-driven consensus on the management of
      patients with confirmed or suspected COVID -19 infection who present with ST-segment
      elevation on ECG. [11,15,16] The NACMI registry will be beneficial in identifying etiology,
      patterns of myocardial injury, developing a risk model for cardiac complications,
      understanding short and long -term major adverse cardiac events, and designing clinical
      trials testing different treatment modalities. Therefore, the registry will include both
      COVID -19 positive patients and PUI with acute cardiovascular conditions. A comparison of PUI
      subsequently confirmed positive to those subsequently confirmed negative will provide a
      unique insight into the pathophysiologic mechanism of STEMI from COVID -19, including
      myocarditis and prothrombotic states. Comparison of patients enrolled in NACMI to
      propensity-matched non -COVID STEMI controls for 1 year prior will provide critical
      information regarding etiology, treatment strategies and clinical outcomes in the COVID -19
      pandemic. As testing for COVID -19 becomes more rapid, this decision -making process is
      expected to evolve. Additionally, it has been reported that overall STEMI volumes have
      decreased in the COVID -19 era, without a clear understanding of the reasons. [17,18] It may
      be that patients are delaying their presentation to the hospital, potentially leading to the
      need for mechanical circulatory support in the acute setting, mechanical complications of
      STEMI, sudden death or an increased heart failure population. Additionally, if patients are
      presenting later in their clinical course, NACMI registry data will allow practitioners to
      improve care models to improve time to treatment in this unique era.
observational model: Cohort
time perspective: Other
measure: The impact of COVID-19 on cardiovascular patient
time frame: 2 month from starting date
description: The outcome of this registry will be:
entire information about the patients who admitted with COVID-19 accompany with a cardiovascular condition in Qatar.
Additionally, a comparison will be conducted between the cardiac patient who admitted over the period February to December to December 2020 and the same category of patients over the same period of 2019 in Qatar to figure out the reason behind the dropping of the number of the patient.
A multicenter data from the Gulf countries for Acute MI patients infected with COVID-19.
A comparison between our patients (either in Qatar only or the entire Gulf) populations and the outcome of other international registries such as the NACMI (US registry)
intervention type: Other
intervention name: No interverntion
description: No intervention will be done, registry only
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Dr.Jassim Alsuwaidi Senior Consultant
role: Principal Investigator
affiliation: HMC
last name: MRC
phone: 44396168
email: MRC@hamad.qa
facility: 
status: Recruiting
contact: 
country: Qatar
responsible party type: Principal Investigator
investigator affiliation: Hamad Medical Corporation
investigator full name: Dr. JASSIM MOHD. AL SUWAIDI
investigator title: Senior Cardiologist
mesh term: Cardiovascular Diseases