<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/NCT03832504</url>
  </required_header>
  <id_info>
    <org_study_id>ICM 2019-2425</org_study_id>
    <nct_id>NCT03832504</nct_id>
  </id_info>
  <brief_title>Identifying Strategies to Alleviate Cardiovascular Stress in Coronary Patients During Heatwaves</brief_title>
  <official_title>Identifying Optimal Cooling Strategies for Coronary Artery Disease Patients During Heatwaves</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Montreal Heart Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Health and Medical Research Council, Australia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Montreal Heart Institute</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 purpose of this study is to determine the optimal cooling strategies to alleviate&#xD;
      cardiovascular strain of coronary artery disease individuals during a simulated North&#xD;
      American and Australian heatwave.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Globally, heatwaves are occurring more frequently, are of greater intensity and longer in&#xD;
      duration. The devastating health impacts of extreme heat are increasingly recognized,&#xD;
      particularly in vulnerable populations, such as adults with coronary artery disease (CAD).&#xD;
      While the most effective cooling strategy during a heatwave is the use of air conditioning&#xD;
      (AC), economical concerns can limit AC use among vulnerable populations. In addition,&#xD;
      widespread AC use places a significant burden on the electrical grid, causing brown-outs and&#xD;
      black-outs during periods of extreme heat.&#xD;
&#xD;
      Electric fans offer a cooling strategy with a 50-fold lower power requirement and cost&#xD;
      compared to AC. However, the efficacy of fan use during heat waves remains contentious. The&#xD;
      primary objective of this study is to identify the optimal cooling strategy to alleviate&#xD;
      cardiovascular strain of CAD patients exposed to typical North American heatwave conditions&#xD;
      (38°C with 60% relative humidity). The secondary objective is to identify the optimal cooling&#xD;
      strategy to alleviate cardiovascular strain of CAD patients exposed to typical Australian&#xD;
      heatwave conditions (46°C with 10% relative humidity).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 18, 2019</start_date>
  <completion_date type="Actual">June 23, 2021</completion_date>
  <primary_completion_date type="Actual">June 23, 2021</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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate pressure product</measure>
    <time_frame>Change from baseline to the end of the 3 hour exposure</time_frame>
    <description>Rate pressure product, in beats per minute per mmHg</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body core temperature</measure>
    <time_frame>Change from baseline to the end of the 3 hour exposure</time_frame>
    <description>In degrees Celcius</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Skin temperature</measure>
    <time_frame>Change from baseline to the end of the 3 hour exposure</time_frame>
    <description>In degrees Celcius</description>
  </other_outcome>
  <other_outcome>
    <measure>Sweat loss</measure>
    <time_frame>Change from baseline to the end of the 3 hour exposure</time_frame>
    <description>In kilograms</description>
  </other_outcome>
  <other_outcome>
    <measure>Local sweat rate</measure>
    <time_frame>Measured continously during the 3 hour exposure</time_frame>
    <description>In mg per minute per cm2</description>
  </other_outcome>
  <other_outcome>
    <measure>Skin blood flow</measure>
    <time_frame>Measured continously during the 3 hour exposure.</time_frame>
    <description>In arbitrary perfusion units</description>
  </other_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>38°C and 60% RH + No intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participant will enter an environmental chamber maintained at 38°C and 60% relative humidity. The participant will remain within the environmental chamber and will rest in a seated position for 3 hours.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>38°C and 60% RH + Fan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participant will enter an environmental chamber maintained at 38°C and 60% relative humidity. The participant will remain within the environmental chamber and will rest in a seated position for 3 hours.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>38°C and 60% RH + Skin wetting</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participant will enter an environmental chamber maintained at 38°C and 60% relative humidity. The participant will remain within the environmental chamber and will rest in a seated position for 3 hours.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>38°C and 60% RH + Fan + Skin wetting</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tthe participant will enter an environmental chamber maintained at 38°C and 60% relative humidity. The participant will remain within the environmental chamber and will rest in a seated position for 3 hours.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>46°C and 10% RH + No intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participant will enter an environmental chamber maintained at 46°C and 10% relative humidity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>46°C and 10% RH + Skin wetting</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participant will enter an environmental chamber maintained at 46°C and 10% relative humidity. The participant will remain within the environmental chamber and will rest in a seated position for 3 hours.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>The participant will rest in a seated position.</description>
    <arm_group_label>38°C and 60% RH + No intervention</arm_group_label>
    <arm_group_label>46°C and 10% RH + No intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fan</intervention_name>
    <description>A fan placed in front of the participant will provide an airflow of 4 m/s throughout the exposure.</description>
    <arm_group_label>38°C and 60% RH + Fan</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Skin Wetting</intervention_name>
    <description>Tap water (~18°C) will be applied every 5 minutes to the face, neck, upper and lower arms and upper and lower legs using a spray bottle.</description>
    <arm_group_label>38°C and 60% RH + Skin wetting</arm_group_label>
    <arm_group_label>46°C and 10% RH + Skin wetting</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fan + Skin wetting</intervention_name>
    <description>A fan placed in front of the participant will provide an airflow of 4 m/s throughout the exposure. In addition, tap water (~18°C) will be applied every 5 minutes to the face, neck, upper and lower arms and upper and lower legs using a spray bottle.</description>
    <arm_group_label>38°C and 60% RH + Fan + Skin wetting</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  History of angiographic coronary disease (≥70% arterial diameter narrowing of at least&#xD;
             one major epicardial coronary artery) and/or prior coronary revascularization and/or&#xD;
             documented prior acute coronary syndrome and/or stable angina and/or perfusion defect&#xD;
             during exercise testing.&#xD;
&#xD;
          -  No CAD-related hospitalisations or changes in cardiac medications or change in pattern&#xD;
             of angina for at least 3 months prior to enrolment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Body mass index ≥35 kg/m2.&#xD;
&#xD;
          -  Currently undertaking estrogen therapy.&#xD;
&#xD;
          -  Evidence of current fluid and electrolyte disorders, anemia, abnormal thyroid&#xD;
             function, arrhythmias, diabetes, renal disease, liver disease, cerebrovascular&#xD;
             disease, significant pulmonary disease, endocrine abnormalities, significant cognitive&#xD;
             impairment, psychiatric disorder, substance abuse, degenerative neurological condition&#xD;
             or any other medical condition deemed to pose risk during the proposed experiments.&#xD;
&#xD;
          -  Uncontrolled hypertension (&gt;180/110 mmHg).&#xD;
&#xD;
          -  Recent (&lt;3 months) coronary bypass surgery.&#xD;
&#xD;
          -  Ejection fraction &lt;40% and/or clinical evidence/history of heart failure.&#xD;
&#xD;
          -  Significant valvular heart disease&#xD;
&#xD;
          -  Resting ECG abnormalities interfering with observation of ST segment changes during&#xD;
             testing.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>cardiovascular Prevention and rehabilitation Centre of the Montreal Heart Institute</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H1T1N6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>January 21, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>July 31, 2023</last_update_submitted>
  <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Montreal Heart Institute</investigator_affiliation>
    <investigator_full_name>Daniel Gagnon</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>All individual data will be de-identified and available to the public through publications, media articles and conference presentations</ipd_description>
  </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/NCT03832504
org study id: ICM 2019-2425
nct id: NCT03832504
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine the optimal cooling strategies to alleviate
      cardiovascular strain of coronary artery disease individuals during a simulated North
      American and Australian heatwave.
Globally, heatwaves are occurring more frequently, are of greater intensity and longer in
      duration. The devastating health impacts of extreme heat are increasingly recognized,
      particularly in vulnerable populations, such as adults with coronary artery disease (CAD).
      While the most effective cooling strategy during a heatwave is the use of air conditioning
      (AC), economical concerns can limit AC use among vulnerable populations. In addition,
      widespread AC use places a significant burden on the electrical grid, causing brown-outs and
      black-outs during periods of extreme heat.

      Electric fans offer a cooling strategy with a 50-fold lower power requirement and cost
      compared to AC. However, the efficacy of fan use during heat waves remains contentious. The
      primary objective of this study is to identify the optimal cooling strategy to alleviate
      cardiovascular strain of CAD patients exposed to typical North American heatwave conditions
      (38°C with 60% relative humidity). The secondary objective is to identify the optimal cooling
      strategy to alleviate cardiovascular strain of CAD patients exposed to typical Australian
      heatwave conditions (46°C with 10% relative humidity).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Rate pressure product
time frame: Change from baseline to the end of the 3 hour exposure
description: Rate pressure product, in beats per minute per mmHg
measure: Body core temperature
time frame: Change from baseline to the end of the 3 hour exposure
description: In degrees Celcius
measure: Skin temperature
time frame: Change from baseline to the end of the 3 hour exposure
description: In degrees Celcius
measure: Sweat loss
time frame: Change from baseline to the end of the 3 hour exposure
description: In kilograms
measure: Local sweat rate
time frame: Measured continously during the 3 hour exposure
description: In mg per minute per cm2
measure: Skin blood flow
time frame: Measured continously during the 3 hour exposure.
description: In arbitrary perfusion units
arm group label: 38°C and 60% RH + No intervention
arm group type: Experimental
description: The participant will enter an environmental chamber maintained at 38°C and 60% relative humidity. The participant will remain within the environmental chamber and will rest in a seated position for 3 hours.
arm group label: 38°C and 60% RH + Fan
arm group type: Experimental
description: The participant will enter an environmental chamber maintained at 38°C and 60% relative humidity. The participant will remain within the environmental chamber and will rest in a seated position for 3 hours.
arm group label: 38°C and 60% RH + Skin wetting
arm group type: Experimental
description: The participant will enter an environmental chamber maintained at 38°C and 60% relative humidity. The participant will remain within the environmental chamber and will rest in a seated position for 3 hours.
arm group label: 38°C and 60% RH + Fan + Skin wetting
arm group type: Experimental
description: Tthe participant will enter an environmental chamber maintained at 38°C and 60% relative humidity. The participant will remain within the environmental chamber and will rest in a seated position for 3 hours.
arm group label: 46°C and 10% RH + No intervention
arm group type: Experimental
description: The participant will enter an environmental chamber maintained at 46°C and 10% relative humidity.
arm group label: 46°C and 10% RH + Skin wetting
arm group type: Experimental
description: The participant will enter an environmental chamber maintained at 46°C and 10% relative humidity. The participant will remain within the environmental chamber and will rest in a seated position for 3 hours.
intervention type: Other
intervention name: No intervention
description: The participant will rest in a seated position.
arm group label: 38°C and 60% RH + No intervention
arm group label: 46°C and 10% RH + No intervention
intervention type: Other
intervention name: Fan
description: A fan placed in front of the participant will provide an airflow of 4 m/s throughout the exposure.
arm group label: 38°C and 60% RH + Fan
intervention type: Other
intervention name: Skin Wetting
description: Tap water (~18°C) will be applied every 5 minutes to the face, neck, upper and lower arms and upper and lower legs using a spray bottle.
arm group label: 38°C and 60% RH + Skin wetting
arm group label: 46°C and 10% RH + Skin wetting
intervention type: Other
intervention name: Fan + Skin wetting
description: A fan placed in front of the participant will provide an airflow of 4 m/s throughout the exposure. In addition, tap water (~18°C) will be applied every 5 minutes to the face, neck, upper and lower arms and upper and lower legs using a spray bottle.
arm group label: 38°C and 60% RH + Fan + Skin wetting
criteria: 
gender: All
minimum age: 50 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Montreal Heart Institute
investigator full name: Daniel Gagnon
investigator title: Principal Investigator
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
sharing ipd: No
ipd description: All individual data will be de-identified and available to the public through publications, media articles and conference presentations