Identifying Strategies to Alleviate Cardiovascular Stress in Coronary Patients During Heatwaves
Identifying Optimal Cooling Strategies for Coronary Artery Disease Patients During Heatwaves
1 other identifier
interventional
27
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable coronary-artery-disease
Started Feb 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2019
CompletedFirst Posted
Study publicly available on registry
February 6, 2019
CompletedStudy Start
First participant enrolled
February 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 23, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 23, 2021
CompletedAugust 1, 2023
July 1, 2023
2.3 years
January 21, 2019
July 31, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Rate pressure product
Rate pressure product, in beats per minute per mmHg
Change from baseline to the end of the 3 hour exposure
Secondary Outcomes (1)
Body core temperature
Change from baseline to the end of the 3 hour exposure
Other Outcomes (4)
Skin temperature
Change from baseline to the end of the 3 hour exposure
Sweat loss
Change from baseline to the end of the 3 hour exposure
Local sweat rate
Measured continously during the 3 hour exposure
- +1 more other outcomes
Study Arms (6)
38°C and 60% RH + No intervention
EXPERIMENTALThe 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.
38°C and 60% RH + Fan
EXPERIMENTALThe 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.
38°C and 60% RH + Skin wetting
EXPERIMENTALThe 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.
38°C and 60% RH + Fan + Skin wetting
EXPERIMENTALTthe 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.
46°C and 10% RH + No intervention
EXPERIMENTALThe participant will enter an environmental chamber maintained at 46°C and 10% relative humidity.
46°C and 10% RH + Skin wetting
EXPERIMENTALThe 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.
Interventions
The participant will rest in a seated position.
A fan placed in front of the participant will provide an airflow of 4 m/s throughout the exposure.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
cardiovascular Prevention and rehabilitation Centre of the Montreal Heart Institute
Montreal, Quebec, H1T1N6, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 21, 2019
First Posted
February 6, 2019
Study Start
February 18, 2019
Primary Completion
June 23, 2021
Study Completion
June 23, 2021
Last Updated
August 1, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share
All individual data will be de-identified and available to the public through publications, media articles and conference presentations