Hot Weather; Adverse EffectPET-HeatNCT04549974
Characterization of Myocardial Blood Flow During Heat Exposure
A study testing Heat exposure in people with Hot Weather; Adverse Effect and Healthy, run by Montreal Heart Institute at 1 site in Canada.
Trial summary
The purpose of this study is to determine the increase in myocardial blood flow during heat exposure and how this response is affected by age and coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hot Weather; Adverse Effect, Healthy, Coronary Artery Disease
- What is being tested?
- Heat exposure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 25 Aug 2020to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18-40 years or 60-80 years
- Non-smoker (≥1 year)
- Non-diabetic
- Normal kidney function
- Body Mass Index <30 kg/m2
- Resting blood pressure <140/<90 mmHg
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- Resting heart rate <100 bpm
- Inclusion Criteria for Participants with Coronary Artery Disease:
- Age between 60-80 years old
- 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 perfusion defect during stress testing
- Stable medications (≥4 weeks) prior to enrollment
Who cannot join
- Diagnosis of heart, vascular, respiratory, neurological or metabolic disease and/or a prescription of medication for the treatment of these diseases
- Pregnancy or lactation
- Dyslipidemia not controlled by medication
- Exclusion Criteria for Participants with Coronary Artery Disease:
- Recent hospitalization (<3 months) related to coronary artery disease
- Unstable angina (<3 months)
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- Recent coronary artery bypass surgery (<3 months)
- Left branch block
- Ejection fraction <40% and/or clinical signs of heart failure
- Severe valvular heart disease
- Hypertension not controlled by medication
- Diabetes not controlled by medication and/or serious complications related to diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterization of the Increase and Distribution of Myocardial Blood Flow During Heat Exposure
The purpose of this study is to determine the increase in myocardial blood flow during heat exposure and how this response is affected by age and coronary artery disease.
Read the detailed description
As a result of climate change, heat waves are more frequent and of longer duration. These heat waves are associated with a higher risk of hospitalization and mortality in vulnerable populations such as people with cardiovascular disease or cardiovascular risk factors. It has been hypothesized that this observation may be explained by the cardiovascular demands imposed by heat exposure.
Heat exposure requires increased cardiac work that may place individuals with cardiovascular disease at risk of ischemic events if the metabolic demand is not compensated by adequate blood supply. However, the extent to which cardiac work increases during heat exposure remains unknown. The aim of this study is to test the hypothesis that heat exposure increases myocardial blood flow and that this increase is affected by age and coronary artery disease.
- Conditions
- Hot Weather; Adverse Effect, Healthy, Coronary Artery Disease, Aging
- Being tested
- Heat exposure
- Keywords
- Heat, PET imaging, Myocardial blood flow
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heat exposureOther
Participants will be exposed to heat exposure via a water-perfused suit to increase internal body temperature by 1.5 degrees Celsius.
| Study group | Role | What they receive |
|---|---|---|
| Passive heat exposure | Experimental | Not described Receives: Other: Heat exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global myocardial blood flow
Measured by PET imaging with 82rubidium
Measured: Change from baseline to an increase in internal body temperature of 1.5 degrees Celsius, estimated average = 90 minutes
Secondary outcomes (4)
Myocardial blood flow distribution
Measured by PET imaging with 82rubidium
Measured: Change from baseline to an increase in internal body temperature of 1.5 degrees Celsius, estimated average = 90 minutes
Heart rate
Measured by electrocardiogram
Measured: Change from baseline to an increase in internal body temperature of 1.5 degrees Celsius, estimated average = 90 minutes
Systolic and diastolic blood pressure
Measured by automated auscultation of the brachial artery
Measured: Change from baseline to an increase in internal body temperature of 1.5 degrees Celsius, estimated average = 90 minutes
Body weight
Measured with a scale
Measured: Measured before and after heat exposure, estimated average = 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start25 Aug 2020
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hot Weather; Adverse EffectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montreal Heart Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Gagnon, Montreal Heart Institute
- Investigators
- Daniel Gagnon, PhD, Principal investigator, Montreal Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04549974
- Sponsor's protocol ID
- ICM 2020-2719
- Acronym
- PET-Heat
- Status last verified
- May 2023
- First submitted
- 25 Aug 2020
- Last updated
- 8 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barry H, Iglesies-Grau J, Chaseling GK, Paul J, Gosselin C, D'Oliviera-Sousa C, Juneau M, Harel F, Kaiser D, Pelletier-Galarneau M, Gagnon D. The Effect of Heat Exposure on Myocardial Blood Flow and Cardiovascular Function. Ann Intern Med. 2024 Jul;177(7):901-910. doi: 10.7326/M24-3504. Epub 2024 Jun 11.
PubMed 38857500
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Increase and Distribution of Myocardial Blood Flow During Heat Exposure
- ClinicalTrials.gov ID
- NCT04549974
- Acronym / sponsor ID
- PET-Heat / ICM 2020-2719
- Conditions
- Hot Weather; Adverse Effect, Healthy, Coronary Artery Disease, Aging
- Keywords
- Heat, PET imaging, Myocardial blood flow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Montreal Heart InstituteUniversity, hospital or other
- Study start
- 25 Aug 2020 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 16 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the increase in myocardial blood flow during heat exposure and how this response is affected by age and coronary artery disease.
Detailed description
As a result of climate change, heat waves are more frequent and of longer duration. These heat waves are associated with a higher risk of hospitalization and mortality in vulnerable populations such as people with cardiovascular disease or cardiovascular risk factors. It has been hypothesized that this observation may be explained by the cardiovascular demands imposed by heat exposure.
Heat exposure requires increased cardiac work that may place individuals with cardiovascular disease at risk of ischemic events if the metabolic demand is not compensated by adequate blood supply. However, the extent to which cardiac work increases during heat exposure remains unknown. The aim of this study is to test the hypothesis that heat exposure increases myocardial blood flow and that this increase is affected by age and coronary artery disease.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Passive heat exposure | Experimental | Other: Heat exposure |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age between 18-40 years or 60-80 years
- Non-smoker (≥1 year)
- Non-diabetic
- Normal kidney function
- Body Mass Index <30 kg/m2
Key exclusion criteria (12 listed)
- Diagnosis of heart, vascular, respiratory, neurological or metabolic disease and/or a prescription of medication for the treatment of these diseases
- Pregnancy or lactation
- Dyslipidemia not controlled by medication
- Recent hospitalization (<3 months) related to coronary artery disease
- Unstable angina (<3 months)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heat exposureParticipants will be exposed to heat exposure via a water-perfused suit to increase internal body temperature by 1.5 degrees Celsius. | Other | Passive heat exposure |
Primary outcome
Global myocardial blood flow
Time frame: Change from baseline to an increase in internal body temperature of 1.5 degrees Celsius, estimated average = 90 minutes
Measured by PET imaging with 82rubidium
4 secondary outcomes
Myocardial blood flow distribution
Time frame: Change from baseline to an increase in internal body temperature of 1.5 degrees Celsius, estimated average = 90 minutes
Heart rate
Time frame: Change from baseline to an increase in internal body temperature of 1.5 degrees Celsius, estimated average = 90 minutes
Systolic and diastolic blood pressure
Time frame: Change from baseline to an increase in internal body temperature of 1.5 degrees Celsius, estimated average = 90 minutes
Body weight
Time frame: Measured before and after heat exposure, estimated average = 120 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2023.
- Derived from this study: PubMed 38857500Barry H, Iglesies-Grau J, Chaseling GK, Paul J, Gosselin C, D'Oliviera-Sousa C, Juneau M, Harel F, Kaiser D, Pelletier-Galarneau M, Gagnon D. The Effect of Heat Exposure on Myocardial Blood Flow and Cardiovascular Function. Ann Intern Med. 2024 Jul;177(7):901-910. doi: 10.7326/M24-3504. Epub 2024 Jun 11.
- Individual participant dataSharing planned: No
Related trials for Hot Weather; Adverse Effect
Recruiting
Beat the Heat Boston
Hot Weather; Adverse Effect, Heat Effect
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Gagnon, PhD principal investigator
Montreal Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heat exposure in people with Hot Weather; Adverse Effect and Healthy, run by Montreal Heart Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global myocardial blood flow (time frame: Change from baseline to an increase in internal body temperature of 1.5 degrees Celsius, estimated average = 90 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04549974, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2023.