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Identifying Strategies to Alleviate Cardiovascular Stress in Coronary Patients During Heatwaves

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
No intervention
Fan
Skin Wetting
Fan + Skin wetting
Sponsored by
Montreal Heart Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Coronary Artery Disease

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • History of angiographic coronary disease (≥70% arterial diameter narrowing of at least one major epicardial coronary artery) and/or prior coronary revascularization and/or documented prior acute coronary syndrome and/or stable angina and/or perfusion defect during exercise testing.
  • No CAD-related hospitalisations or changes in cardiac medications or change in pattern of angina for at least 3 months prior to enrolment

Exclusion Criteria:

  • Body mass index ≥35 kg/m2.
  • Currently undertaking estrogen therapy.
  • Evidence of current fluid and electrolyte disorders, anemia, abnormal thyroid function, arrhythmias, diabetes, renal disease, liver disease, cerebrovascular disease, significant pulmonary disease, endocrine abnormalities, significant cognitive impairment, psychiatric disorder, substance abuse, degenerative neurological condition or any other medical condition deemed to pose risk during the proposed experiments.
  • Uncontrolled hypertension (>180/110 mmHg).
  • Recent (<3 months) coronary bypass surgery.
  • Ejection fraction <40% and/or clinical evidence/history of heart failure.
  • Significant valvular heart disease
  • Resting ECG abnormalities interfering with observation of ST segment changes during testing.

Sites / Locations

  • cardiovascular Prevention and rehabilitation Centre of the Montreal Heart Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

38°C and 60% RH + No intervention

38°C and 60% RH + Fan

38°C and 60% RH + Skin wetting

38°C and 60% RH + Fan + Skin wetting

46°C and 10% RH + No intervention

46°C and 10% RH + Skin wetting

Arm 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.

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.

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.

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.

The participant will enter an environmental chamber maintained at 46°C and 10% relative humidity.

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.

Outcomes

Primary Outcome Measures

Rate pressure product
Rate pressure product, in beats per minute per mmHg

Secondary Outcome Measures

Body core temperature
In degrees Celcius

Full Information

First Posted
January 21, 2019
Last Updated
July 31, 2023
Sponsor
Montreal Heart Institute
Collaborators
National Health and Medical Research Council, Australia
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1. Study Identification

Unique Protocol Identification Number
NCT03832504
Brief Title
Identifying Strategies to Alleviate Cardiovascular Stress in Coronary Patients During Heatwaves
Official Title
Identifying Optimal Cooling Strategies for Coronary Artery Disease Patients During Heatwaves
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
February 18, 2019 (Actual)
Primary Completion Date
June 23, 2021 (Actual)
Study Completion Date
June 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montreal Heart Institute
Collaborators
National Health and Medical Research Council, Australia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
38°C and 60% RH + No intervention
Arm Type
Experimental
Arm 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 Title
38°C and 60% RH + Fan
Arm Type
Experimental
Arm 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 Title
38°C and 60% RH + Skin wetting
Arm Type
Experimental
Arm 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 Title
38°C and 60% RH + Fan + Skin wetting
Arm Type
Experimental
Arm 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 Title
46°C and 10% RH + No intervention
Arm Type
Experimental
Arm Description
The participant will enter an environmental chamber maintained at 46°C and 10% relative humidity.
Arm Title
46°C and 10% RH + Skin wetting
Arm Type
Experimental
Arm 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(s)
No intervention
Intervention Description
The participant will rest in a seated position.
Intervention Type
Other
Intervention Name(s)
Fan
Intervention Description
A fan placed in front of the participant will provide an airflow of 4 m/s throughout the exposure.
Intervention Type
Other
Intervention Name(s)
Skin Wetting
Intervention 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.
Intervention Type
Other
Intervention Name(s)
Fan + Skin wetting
Intervention 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.
Primary Outcome Measure Information:
Title
Rate pressure product
Description
Rate pressure product, in beats per minute per mmHg
Time Frame
Change from baseline to the end of the 3 hour exposure
Secondary Outcome Measure Information:
Title
Body core temperature
Description
In degrees Celcius
Time Frame
Change from baseline to the end of the 3 hour exposure
Other Pre-specified Outcome Measures:
Title
Skin temperature
Description
In degrees Celcius
Time Frame
Change from baseline to the end of the 3 hour exposure
Title
Sweat loss
Description
In kilograms
Time Frame
Change from baseline to the end of the 3 hour exposure
Title
Local sweat rate
Description
In mg per minute per cm2
Time Frame
Measured continously during the 3 hour exposure
Title
Skin blood flow
Description
In arbitrary perfusion units
Time Frame
Measured continously during the 3 hour exposure.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: History of angiographic coronary disease (≥70% arterial diameter narrowing of at least one major epicardial coronary artery) and/or prior coronary revascularization and/or documented prior acute coronary syndrome and/or stable angina and/or perfusion defect during exercise testing. No CAD-related hospitalisations or changes in cardiac medications or change in pattern of angina for at least 3 months prior to enrolment Exclusion Criteria: Body mass index ≥35 kg/m2. Currently undertaking estrogen therapy. Evidence of current fluid and electrolyte disorders, anemia, abnormal thyroid function, arrhythmias, diabetes, renal disease, liver disease, cerebrovascular disease, significant pulmonary disease, endocrine abnormalities, significant cognitive impairment, psychiatric disorder, substance abuse, degenerative neurological condition or any other medical condition deemed to pose risk during the proposed experiments. Uncontrolled hypertension (>180/110 mmHg). Recent (<3 months) coronary bypass surgery. Ejection fraction <40% and/or clinical evidence/history of heart failure. Significant valvular heart disease Resting ECG abnormalities interfering with observation of ST segment changes during testing.
Facility Information:
Facility Name
cardiovascular Prevention and rehabilitation Centre of the Montreal Heart Institute
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T1N6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
All individual data will be de-identified and available to the public through publications, media articles and conference presentations

Learn more about this trial

Identifying Strategies to Alleviate Cardiovascular Stress in Coronary Patients During Heatwaves

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