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CompletedNCT03832504Updated Aug 1, 2023

Identifying Strategies to Alleviate Cardiovascular Stress in Coronary Patients During Heatwaves

An interventional study of No intervention and Fan in Coronary Artery Disease, sponsored by Montreal Heart Institute. Completed at 1 site in Canada. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-08-01.

Sponsored by Montreal Heart Institute · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
27
Allocation
Randomized
Ages
50 Years to 80 Years
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 27 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Montreal Heart Institute is the lead sponsor of 101 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
27 participants (actual)

Study arms

  • Experimental
    38°C and 60% RH + No intervention

    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.

    Other: No intervention

  • Experimental
    38°C and 60% RH + Fan

    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.

    Other: Fan

  • Experimental
    38°C and 60% RH + Skin wetting

    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.

    Other: Skin Wetting

  • Experimental
    38°C and 60% RH + Fan + Skin wetting

    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.

    Other: Fan + Skin wetting

  • Experimental
    46°C and 10% RH + No intervention

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

    Other: No intervention

  • Experimental
    46°C and 10% RH + Skin wetting

    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.

    Other: Skin Wetting

Interventions

  • OtherNo intervention

    The participant will rest in a seated position.

  • OtherFan

    A fan placed in front of the participant will provide an airflow of 4 m/s throughout the exposure.

  • OtherSkin Wetting

    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.

  • OtherFan + Skin wetting

    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.

06

What researchers measure

Primary outcomes

  1. Rate pressure product

    Rate pressure product, in beats per minute per mmHg

    Time frame: Change from baseline to the end of the 3 hour exposure

Secondary outcomes

  1. Body core temperature

    In degrees Celcius

    Time frame: Change from baseline to the end of the 3 hour exposure

Other outcomes

  1. Skin temperature

    In degrees Celcius

    Time frame: Change from baseline to the end of the 3 hour exposure

  2. Sweat loss

    In kilograms

    Time frame: Change from baseline to the end of the 3 hour exposure

  3. Local sweat rate

    In mg per minute per cm2

    Time frame: Measured continously during the 3 hour exposure

  4. Skin blood flow

    In arbitrary perfusion units

    Time frame: Measured continously during the 3 hour exposure.

07

Study locations

1 site
  • cardiovascular Prevention and rehabilitation Centre of the Montreal Heart Institute
    Montréal, Quebec H1T1N6, Canada
08

References and documents

Individual participant data

Plan to share: No — All individual data will be de-identified and available to the public through publications, media articles and conference presentations

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03832504
Lead sponsor
Montreal Heart Institute
Collaborators
National Health and Medical Research Council, Australia
Responsible party
Daniel Gagnon (Principal Investigator, Montreal Heart Institute) — Principal investigator
First posted
Feb 6, 2019
Start date
Feb 18, 2019
Primary completion
Jun 23, 2021
Completion
Jun 23, 2021
Last update
Aug 1, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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