<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/NCT04440761</url>
  </required_header>
  <id_info>
    <org_study_id>REDA: 130386</org_study_id>
    <nct_id>NCT04440761</nct_id>
  </id_info>
  <brief_title>Barts-MINOCA Registry</brief_title>
  <official_title>Barts Myocardial Infarction With Non-Obstructed Coronary Arteries (MINOCA) Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Queen Mary University of London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Queen Mary University of London</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>
      The last 15 years the introduction of primary angioplasty has radically improved outcomes for&#xD;
      acute myocardial infarction (AMI). However, the system wide availability of prompt&#xD;
      investigation has revealed an important group of patients where progress has stalled, the&#xD;
      diagnosis is unclear and therapeutic approaches are uncertain. Myocardial infarction with&#xD;
      non-obstructive coronary arteries (MINOCA) is found in 1 - 13% of all patients with a&#xD;
      clinical diagnosis of AMI.&#xD;
&#xD;
      These patients present a therapeutic predicament since coronary revascularization is not&#xD;
      appropriate. Guidelines do not exist for their management - yet the condition is not benign -&#xD;
      the 12-month prognosis, although better than obstructive coronary artery disease patients is&#xD;
      still guarded with recent data suggesting many questions remain unanswered.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study utilises a prospectively collected clinical database. All patients referred to the&#xD;
      Interventional Cardiology team are included onto this database. No patients will be contacted&#xD;
      solely for research purposes. Patients will not have any investigations/procedures performed&#xD;
      for research purposes. All data will only be available for access by named members of the&#xD;
      Interventional Cardiology team. Data will be anonymised by the clinical care team and passed&#xD;
      onto the research team before it is used and no patient identifiable information will be used&#xD;
      in the analysis of the study or the publications of its results.&#xD;
&#xD;
      The database started in April 2015 and has collected data on all patients so far and will&#xD;
      continue to do so for the duration of clinical work by the Interventional Cardiology team. As&#xD;
      a result this study will continue indefinitely.&#xD;
&#xD;
      This study will include all patients admitted to or reviewed in clinic at Barts Health NHS&#xD;
      Trust with either a diagnosis of MINOCA or who do not have a clear cause of a troponin rise.&#xD;
      These patients range from young adults to the elderly and will include any patient ≥16 years&#xD;
      of age. Patients who are followed up with and without any intervention (i.e. both medically&#xD;
      managed patients as well as patients undergoing intervention) are equally as important and&#xD;
      therefore the investigators shall include both groups of patients.&#xD;
&#xD;
      Patients will be included from referrals made by other clinicians either as in or&#xD;
      outpatients. All these patients have their clinical data captured on a database or hospital&#xD;
      based clinical programme.&#xD;
&#xD;
      This study aims to assess, in a real-world setting, the safety, efficacy and feasibility of&#xD;
      further investigations in patients diagnosed with MINOCA among all patients with coronary&#xD;
      artery disease.&#xD;
&#xD;
      The study will test various hypothesis including but not limited to:&#xD;
&#xD;
        1. The efficacy of diagnosis rates of CMR in patients diagnosed with MINOCA&#xD;
&#xD;
        2. Outcomes in patients diagnosed with MINOCA treated medically&#xD;
&#xD;
        3. Long-term outcome of patients diagnosed with MINOCA&#xD;
    </textblock>
  </detailed_description>
  <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>5 Years</target_duration>
  <primary_outcome>
    <measure>Mortality</measure>
    <time_frame>30 days</time_frame>
    <description>Assessment of mortality</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mortality</measure>
    <time_frame>1 year</time_frame>
    <description>Assessment of mortality</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Formal diagnosis made of the cause of troponin rise</measure>
    <time_frame>Baseline</time_frame>
    <description>Diagnosis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Timing of diagnosis made of the cause of troponin rise</measure>
    <time_frame>Baseline</time_frame>
    <description>Time to first diagnosis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Questionnaire to assess change in symptoms at 2 months post-initial review in clinic/ward</measure>
    <time_frame>2 months</time_frame>
    <description>Change in symptoms assessed by Questionnaire</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">3000</enrollment>
  <condition>Myocardial Infarction</condition>
  <condition>Gender</condition>
  <condition>Coronary Microvascular Disease</condition>
  <arm_group>
    <arm_group_label>Troponin rise/ diagnosis of MINOCA</arm_group_label>
    <description>This study aims to assess, in a real-world setting, the safety, efficacy and feasibility of further investigations in patients diagnosed with MINOCA among all patients with coronary artery disease.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observation only</intervention_name>
    <description>Observation only</description>
    <arm_group_label>Troponin rise/ diagnosis of MINOCA</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This study will include all patients admitted to or reviewed in clinic at Barts Health NHS&#xD;
        Trust with either a diagnosis of MINOCA or who do not have a clear cause of a troponin&#xD;
        rise. These patients range from young adults to the elderly and will include any patient&#xD;
        ≥16 years of age. Patients who are followed up with and without any intervention (i.e. both&#xD;
        medically managed patients as well as patients undergoing intervention) are equally as&#xD;
        important and therefore we shall include both groups of patients.&#xD;
&#xD;
        Patients will be included from referrals made by other clinicians either as in or&#xD;
        outpatients. All these patients have their clinical data captured on a database or hospital&#xD;
        based clinical programme.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Both male and female patients ≥16 years of age will be included&#xD;
&#xD;
          -  All patients will have a diagnosis MINOCA. Any patient who does not have a clear cause&#xD;
             of troponin rise&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients &lt;16 years will not be included in this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Jones, MBBS, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Queen Mary University of London</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Daniel Jones, MBBS, PhD</last_name>
    <phone>020 7377 7000</phone>
    <email>dan.jones8@nhs.net</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Krishnaraj Rathod, MBBS, PhD</last_name>
    <phone>020 7377 7000</phone>
    <email>krishnaraj.rathod1@nhs.net</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Barts Health NHS Trust</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dr Anne-Marie Beirne</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>August 7, 2023</last_update_submitted>
  <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Microvascular Angina</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04440761
org study id: REDA: 130386
nct id: NCT04440761
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The last 15 years the introduction of primary angioplasty has radically improved outcomes for
      acute myocardial infarction (AMI). However, the system wide availability of prompt
      investigation has revealed an important group of patients where progress has stalled, the
      diagnosis is unclear and therapeutic approaches are uncertain. Myocardial infarction with
      non-obstructive coronary arteries (MINOCA) is found in 1 - 13% of all patients with a
      clinical diagnosis of AMI.

      These patients present a therapeutic predicament since coronary revascularization is not
      appropriate. Guidelines do not exist for their management - yet the condition is not benign -
      the 12-month prognosis, although better than obstructive coronary artery disease patients is
      still guarded with recent data suggesting many questions remain unanswered.
This study utilises a prospectively collected clinical database. All patients referred to the
      Interventional Cardiology team are included onto this database. No patients will be contacted
      solely for research purposes. Patients will not have any investigations/procedures performed
      for research purposes. All data will only be available for access by named members of the
      Interventional Cardiology team. Data will be anonymised by the clinical care team and passed
      onto the research team before it is used and no patient identifiable information will be used
      in the analysis of the study or the publications of its results.

      The database started in April 2015 and has collected data on all patients so far and will
      continue to do so for the duration of clinical work by the Interventional Cardiology team. As
      a result this study will continue indefinitely.

      This study will include all patients admitted to or reviewed in clinic at Barts Health NHS
      Trust with either a diagnosis of MINOCA or who do not have a clear cause of a troponin rise.
      These patients range from young adults to the elderly and will include any patient ≥16 years
      of age. Patients who are followed up with and without any intervention (i.e. both medically
      managed patients as well as patients undergoing intervention) are equally as important and
      therefore the investigators shall include both groups of patients.

      Patients will be included from referrals made by other clinicians either as in or
      outpatients. All these patients have their clinical data captured on a database or hospital
      based clinical programme.

      This study aims to assess, in a real-world setting, the safety, efficacy and feasibility of
      further investigations in patients diagnosed with MINOCA among all patients with coronary
      artery disease.

      The study will test various hypothesis including but not limited to:

        1. The efficacy of diagnosis rates of CMR in patients diagnosed with MINOCA

        2. Outcomes in patients diagnosed with MINOCA treated medically

        3. Long-term outcome of patients diagnosed with MINOCA
observational model: Cohort
time perspective: Prospective
measure: Mortality
time frame: 30 days
description: Assessment of mortality
measure: Mortality
time frame: 1 year
description: Assessment of mortality
measure: Formal diagnosis made of the cause of troponin rise
time frame: Baseline
description: Diagnosis
measure: Timing of diagnosis made of the cause of troponin rise
time frame: Baseline
description: Time to first diagnosis
measure: Questionnaire to assess change in symptoms at 2 months post-initial review in clinic/ward
time frame: 2 months
description: Change in symptoms assessed by Questionnaire
arm group label: Troponin rise/ diagnosis of MINOCA
description: This study aims to assess, in a real-world setting, the safety, efficacy and feasibility of further investigations in patients diagnosed with MINOCA among all patients with coronary artery disease.
intervention type: Other
intervention name: Observation only
description: Observation only
arm group label: Troponin rise/ diagnosis of MINOCA
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Daniel Jones, MBBS, PhD
role: Principal Investigator
affiliation: Queen Mary University of London
last name: Daniel Jones, MBBS, PhD
phone: 020 7377 7000
email: dan.jones8@nhs.net
last name: Krishnaraj Rathod, MBBS, PhD
phone: 020 7377 7000
email: krishnaraj.rathod1@nhs.net
facility: 
status: Recruiting
contact: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Myocardial Infarction
mesh term: Microvascular Angina
mesh term: Infarction
sharing ipd: No