<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/NCT04485754</url>
  </required_header>
  <id_info>
    <org_study_id>TeleFU</org_study_id>
    <nct_id>NCT04485754</nct_id>
  </id_info>
  <brief_title>Telemedicine Follow-up for Post-ACS Patients</brief_title>
  <official_title>Telemedicine Follow-up for Post-Acute Coronary Syndrome Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tomsk National Research Medical Center of the Russian Academy of Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tomsk National Research Medical Center of the Russian Academy of Sciences</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>
      The aim is to compare the safety of using telemedicine and office visit follow-up in&#xD;
      post-acute coronary syndrome patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rehabilitation after acute coronary syndrome includes visits to the cardiologist's office at&#xD;
      1, 2, 6 and 12 months after discharge. Due to the Covid-19 pandemic, visiting a&#xD;
      cardiologist's office maybe impossible. In such cases telemedicine follow-up visit would be&#xD;
      reasonable choice. Taking into account the absence of studies in this area, providing&#xD;
      investigation evaluating parameters of safety for both methodics is relevant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 15, 2020</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>MACCE</measure>
    <time_frame>1 year</time_frame>
    <description>Major adverse cardiac and cerebrovascular events: cardiac death, myocardial infarction, or stroke</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>High level of MT optimization</measure>
    <time_frame>1 year</time_frame>
    <description>High Level of Medical Therapy Optimization is defined as a participant meeting all of the following goals: LDL &lt; 1.4 mmol/L and on any statin, blood pressure &lt; 140/90 mm/Hg (&lt;135/85 mm/Hg for patients with diabetes mellitus), on aspirin or other antiplatelet or anticoagulant, and not smoking. High level of medical therapy optimization is missing if any of the individual goals are missing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PB &lt; 140/90 mm/Hg (&lt;135/85 mm/Hg for Diabetes)</measure>
    <time_frame>1 year</time_frame>
    <description>Blood pressure &lt; 140 mm/Hg (&lt;135/85 mm/Hg for for patients with diabetes mellitus)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LDL &lt; 1.4 mmol/L</measure>
    <time_frame>1 year</time_frame>
    <description>Low density lipoprotein&lt; 1.4 mmol/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Not smoking</measure>
    <time_frame>1 year</time_frame>
    <description>Not smoking</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decrease in overweight</measure>
    <time_frame>1 year</time_frame>
    <description>Decrease in overweight</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aspirin or other antiplatelet or anticoagulant</measure>
    <time_frame>1 year</time_frame>
    <description>Adherence to aspirin or other antiplatelet or anticoagulant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence to prescribed medication</measure>
    <time_frame>1 year</time_frame>
    <description>Adherence to prescribed at discharge medication</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalization</measure>
    <time_frame>1 year</time_frame>
    <description>Hospitalization for cardiac reasons</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">88</enrollment>
  <condition>ACS - Acute Coronary Syndrome</condition>
  <arm_group>
    <arm_group_label>Telemedicine FU</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Telemedicine follow-up visit at 1, 3, and 6 months or 1 and 6 months after discharge from hospital.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Office FU</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Office follow-up visit at 1, 3, and 6 months or 1 and 6 months after discharge from hospital.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Telemedicine FU</intervention_name>
    <description>Participant will get telemedicine follow-up visit at 1, 3, and 6 months or 1 and 6 months after discharge from hospital.</description>
    <arm_group_label>Telemedicine FU</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Office FU</intervention_name>
    <description>Participant will get office follow-up visit at 1, 3, and 6 months or 1 and 6 months after discharge from hospital.</description>
    <arm_group_label>Office FU</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Signed informed consent&#xD;
&#xD;
          2. Age ≥ 40 years&#xD;
&#xD;
          3. PCI with coronary artery stenting for ACS&#xD;
&#xD;
          4. Angiographic success PCI&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with cancer&#xD;
&#xD;
          2. Severe CHF (EF LV &lt;35% or functional class of heart failure III-IV NYHA)&#xD;
&#xD;
          3. Severe valvular heart disease or Prosthetic heart valves.&#xD;
&#xD;
          4. Severe forms of CKD (GFR&lt;30mL/min)&#xD;
&#xD;
          5. Planned staged revascularization during the next 12 months&#xD;
&#xD;
          6. Planned surgery within the next 12 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ivan S Bessonov, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tyumen Cardiology Research Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tyumen Cardiology Research Center, Tomsk National Research Medical Center, Russian Academy of Science</name>
      <address>
        <city>Tyumen</city>
        <zip>625026</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>April 26, 2022</last_update_submitted>
  <last_update_submitted_qc>April 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Telemedicine follow-up visit</keyword>
  <keyword>Post-ACS rehabilitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Syndrome</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/NCT04485754
org study id: TeleFU
nct id: NCT04485754
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim is to compare the safety of using telemedicine and office visit follow-up in
      post-acute coronary syndrome patients
Rehabilitation after acute coronary syndrome includes visits to the cardiologist's office at
      1, 2, 6 and 12 months after discharge. Due to the Covid-19 pandemic, visiting a
      cardiologist's office maybe impossible. In such cases telemedicine follow-up visit would be
      reasonable choice. Taking into account the absence of studies in this area, providing
      investigation evaluating parameters of safety for both methodics is relevant.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: MACCE
time frame: 1 year
description: Major adverse cardiac and cerebrovascular events: cardiac death, myocardial infarction, or stroke
measure: High level of MT optimization
time frame: 1 year
description: High Level of Medical Therapy Optimization is defined as a participant meeting all of the following goals: LDL < 1.4 mmol/L and on any statin, blood pressure < 140/90 mm/Hg (<135/85 mm/Hg for patients with diabetes mellitus), on aspirin or other antiplatelet or anticoagulant, and not smoking. High level of medical therapy optimization is missing if any of the individual goals are missing.
measure: PB < 140/90 mm/Hg (<135/85 mm/Hg for Diabetes)
time frame: 1 year
description: Blood pressure < 140 mm/Hg (<135/85 mm/Hg for for patients with diabetes mellitus)
measure: LDL < 1.4 mmol/L
time frame: 1 year
description: Low density lipoprotein< 1.4 mmol/L
measure: Not smoking
time frame: 1 year
description: Not smoking
measure: Decrease in overweight
time frame: 1 year
description: Decrease in overweight
measure: Aspirin or other antiplatelet or anticoagulant
time frame: 1 year
description: Adherence to aspirin or other antiplatelet or anticoagulant
measure: Adherence to prescribed medication
time frame: 1 year
description: Adherence to prescribed at discharge medication
measure: Hospitalization
time frame: 1 year
description: Hospitalization for cardiac reasons
arm group label: Telemedicine FU
arm group type: Experimental
description: Telemedicine follow-up visit at 1, 3, and 6 months or 1 and 6 months after discharge from hospital.
arm group label: Office FU
arm group type: Active Comparator
description: Office follow-up visit at 1, 3, and 6 months or 1 and 6 months after discharge from hospital.
intervention type: Other
intervention name: Telemedicine FU
description: Participant will get telemedicine follow-up visit at 1, 3, and 6 months or 1 and 6 months after discharge from hospital.
arm group label: Telemedicine FU
intervention type: Other
intervention name: Office FU
description: Participant will get office follow-up visit at 1, 3, and 6 months or 1 and 6 months after discharge from hospital.
arm group label: Office FU
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Ivan S Bessonov, MD, PhD
role: Principal Investigator
affiliation: Tyumen Cardiology Research Center
facility: 
country: Russian Federation
responsible party type: Sponsor
mesh term: Acute Coronary Syndrome
mesh term: Syndrome
sharing ipd: No