<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/NCT04424368</url>
  </required_header>
  <id_info>
    <org_study_id>191119</org_study_id>
    <nct_id>NCT04424368</nct_id>
  </id_info>
  <brief_title>Remote Monitoring System for Patients, Who Had Myocardial Infarction</brief_title>
  <official_title>Creation and Evaluation of the Effectiveness of the Remote Monitoring System for Patients, Who Had Myocardial Infarction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ryazan State Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ryazan State Medical University</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>
      one-centered, open, prospective, non-randomized, controlled clinical study will be aimed at&#xD;
      creating remote monitoring system for patients' condition and the development of&#xD;
      methodological approaches and its usage for conducting patients, who had myocardial&#xD;
      infraction and who has a very high risk of developing an unfavorable outcome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The research will involve patients, who had myocardial infraction and who has the high level&#xD;
      of potential adherence to treatment, which will be determined by the usage of Russian generic&#xD;
      questionnaire for evaluation of compliance to drug therapy. At the end of a 12 month&#xD;
      observation with the registration of unfavorable cardiovascular occasions (death from&#xD;
      cardiovascular reasons, nonfatal myocardial infraction, cerebral stroke, necessity for&#xD;
      repeated revascularization of the coronary arteries) based on the analysis of non-genetic and&#xD;
      genetic factors (polymorphism of genes Thr174Met and Met235Thr in gene angiotensinogen,&#xD;
      Arg389Gly and Ser49Gly in gene adrenoceptor beta 1, Ser447Ter in gene lipoprotein lipase and&#xD;
      Leu28Pro in gene apolipoprotein E, Trp212Ter and G681A in gene cytochrome P450 family 2&#xD;
      subfamily C member 19) factors of unfavorable prognosis will be identified and considering&#xD;
      which group of patients requires the use of remote monitoring system will be formed. From one&#xD;
      group of patients we will form two comparable groups, one group will use this remote&#xD;
      monitoring system and another will not. The effectiveness of the remote monitoring system&#xD;
      will be evaluated after 6-month's observation based on the registration of the unfavorable&#xD;
      cardiovascular occasions (death from cardiovascular reasons, nonfatal myocardial infraction,&#xD;
      cerebral stroke, necessity for repeated revascularization of the coronary arteries, frequency&#xD;
      of hospitalizations).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">October 3, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 3, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>cardiovascular mortality</measure>
    <time_frame>12 months</time_frame>
    <description>the number of deaths from cardiovascular causes</description>
  </primary_outcome>
  <primary_outcome>
    <measure>acute myocardial infarction</measure>
    <time_frame>12 months</time_frame>
    <description>incidence of acute myocardial infarction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>cerebral stroke</measure>
    <time_frame>12 months</time_frame>
    <description>incidence of cerebral stroke</description>
  </primary_outcome>
  <primary_outcome>
    <measure>revascularization</measure>
    <time_frame>12 months</time_frame>
    <description>frequency of repeated revascularization of coronary arteries</description>
  </primary_outcome>
  <primary_outcome>
    <measure>hospitalization</measure>
    <time_frame>12 months</time_frame>
    <description>frequency of hospitalization about the progression of coronary heart disease</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">250</enrollment>
  <condition>Myocardial Infarction</condition>
  <condition>Adherence, Patient</condition>
  <arm_group>
    <arm_group_label>The remote monitoring system</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A group of patients, who had myocardial infraction and who has a very high risk of developing an unfavorable prognosis, which are followed up in the local outpatient department according to existing clinical recommendations and using remote monitoring system.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Clinical recommendations</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>A group of patients, who had myocardial infraction and who has a very high risk of developing an unfavorable prognosis, which are followed up in the local outpatient department according to existing clinical recommendations.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>The remote monitoring system</intervention_name>
    <description>Usage of remote monitoring system</description>
    <arm_group_label>The remote monitoring system</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. A significant diagnosis of myocardial infraction, confirmed by the level of biomarkers&#xD;
             of myocardial necrosis in blood examination (troponin, creatine kinase-MV),&#xD;
             electrocardiographic criteria, typical clinical presentation.&#xD;
&#xD;
          2. The high level of adherence to treatment&#xD;
&#xD;
          3. Signed informed agreement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Active cancer or remission period less than 5 years;&#xD;
&#xD;
          2. Absolute contradictions to the prescription of beta-adrenergic blocking agents,&#xD;
             angiotensin converting enzyme inhibitors, statins, antiaggregants.&#xD;
&#xD;
          3. Mental illnesses.&#xD;
&#xD;
          4. Alcohol and drug abuse&#xD;
&#xD;
          5. Patient's noncompliance, according to the researchers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kristina Pereverzeva, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>RyazSMU</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>RyazSMU</name>
      <address>
        <city>Ryazan'</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>November 6, 2021</last_update_submitted>
  <last_update_submitted_qc>November 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>myocardial infraction</keyword>
  <keyword>the high level of potential adherence to treatment</keyword>
  <keyword>polymorphism of genes</keyword>
  <keyword>remote monitoring, 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>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>January 30, 2022</submitted>
    <returned>April 1, 2022</returned>
    <submitted>September 5, 2022</submitted>
    <returned>July 24, 2023</returned>
  </pending_results>
  <!-- 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/NCT04424368
org study id: 191119
nct id: NCT04424368
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
one-centered, open, prospective, non-randomized, controlled clinical study will be aimed at
      creating remote monitoring system for patients' condition and the development of
      methodological approaches and its usage for conducting patients, who had myocardial
      infraction and who has a very high risk of developing an unfavorable outcome.
The research will involve patients, who had myocardial infraction and who has the high level
      of potential adherence to treatment, which will be determined by the usage of Russian generic
      questionnaire for evaluation of compliance to drug therapy. At the end of a 12 month
      observation with the registration of unfavorable cardiovascular occasions (death from
      cardiovascular reasons, nonfatal myocardial infraction, cerebral stroke, necessity for
      repeated revascularization of the coronary arteries) based on the analysis of non-genetic and
      genetic factors (polymorphism of genes Thr174Met and Met235Thr in gene angiotensinogen,
      Arg389Gly and Ser49Gly in gene adrenoceptor beta 1, Ser447Ter in gene lipoprotein lipase and
      Leu28Pro in gene apolipoprotein E, Trp212Ter and G681A in gene cytochrome P450 family 2
      subfamily C member 19) factors of unfavorable prognosis will be identified and considering
      which group of patients requires the use of remote monitoring system will be formed. From one
      group of patients we will form two comparable groups, one group will use this remote
      monitoring system and another will not. The effectiveness of the remote monitoring system
      will be evaluated after 6-month's observation based on the registration of the unfavorable
      cardiovascular occasions (death from cardiovascular reasons, nonfatal myocardial infraction,
      cerebral stroke, necessity for repeated revascularization of the coronary arteries, frequency
      of hospitalizations).
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: cardiovascular mortality
time frame: 12 months
description: the number of deaths from cardiovascular causes
measure: acute myocardial infarction
time frame: 12 months
description: incidence of acute myocardial infarction
measure: cerebral stroke
time frame: 12 months
description: incidence of cerebral stroke
measure: revascularization
time frame: 12 months
description: frequency of repeated revascularization of coronary arteries
measure: hospitalization
time frame: 12 months
description: frequency of hospitalization about the progression of coronary heart disease
arm group label: The remote monitoring system
arm group type: Experimental
description: A group of patients, who had myocardial infraction and who has a very high risk of developing an unfavorable prognosis, which are followed up in the local outpatient department according to existing clinical recommendations and using remote monitoring system.
arm group label: Clinical recommendations
arm group type: No Intervention
description: A group of patients, who had myocardial infraction and who has a very high risk of developing an unfavorable prognosis, which are followed up in the local outpatient department according to existing clinical recommendations.
intervention type: Device
intervention name: The remote monitoring system
description: Usage of remote monitoring system
arm group label: The remote monitoring system
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kristina Pereverzeva, MD, PhD
role: Principal Investigator
affiliation: RyazSMU
facility: 
country: Russian Federation
responsible party type: Sponsor
mesh term: Myocardial Infarction
mesh term: Infarction
sharing ipd: No
submitted: January 30, 2022
returned: April 1, 2022
submitted: September 5, 2022
returned: July 24, 2023