Identifying Strategies to Alleviate Cardiovascular Stress in Coronary Patients During Heatwaves

July 31, 2023 updated by: Daniel Gagnon, Montreal Heart Institute

Identifying Optimal Cooling Strategies for Coronary Artery Disease Patients During Heatwaves

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H1T1N6
        • Cardiovascular Prevention and Rehabilitation Centre of the Montreal Heart Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
The participant will rest in a seated position.
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
A fan placed in front of the participant will provide an airflow of 4 m/s throughout the exposure.
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
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.
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
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.
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
The participant will rest in a seated position.
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate pressure product
Time Frame: Change from baseline to the end of the 3 hour exposure
Rate pressure product, in beats per minute per mmHg
Change from baseline to the end of the 3 hour exposure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body core temperature
Time Frame: Change from baseline to the end of the 3 hour exposure
In degrees Celcius
Change from baseline to the end of the 3 hour exposure

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Skin temperature
Time Frame: Change from baseline to the end of the 3 hour exposure
In degrees Celcius
Change from baseline to the end of the 3 hour exposure
Sweat loss
Time Frame: Change from baseline to the end of the 3 hour exposure
In kilograms
Change from baseline to the end of the 3 hour exposure
Local sweat rate
Time Frame: Measured continously during the 3 hour exposure
In mg per minute per cm2
Measured continously during the 3 hour exposure
Skin blood flow
Time Frame: Measured continously during the 3 hour exposure.
In arbitrary perfusion units
Measured continously during the 3 hour exposure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Montreal Heart Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Health and Medical Research Council, Australia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 18, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 23, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 23, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 21, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 6, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 1, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ICM 2019-2425

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

All individual data will be de-identified and available to the public through publications, media articles and conference presentations

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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