- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04549974
Characterization of Myocardial Blood Flow During Heat Exposure (PET-Heat)
Characterization of the Increase and Distribution of Myocardial Blood Flow During Heat Exposure
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Daniel Gagnon, PhD
- Phone Number: 4205 514-374-1480
- Email: daniel.gagnon.3@umontreal.ca
Study Contact Backup
- Name: Hadiatou Barry, MSc
- Phone Number: 4265 514-374-1480
- Email: hadiatou.barry@umontreal.ca
Study Locations
-
-
Quebec
-
Montréal, Quebec, Canada, H1T1C8
- Montreal Heart Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria for Healthy Participants:
- 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
- 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
Exclusion Criteria for Healthy Participants:
- 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)
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Passive heat exposure
|
Participants will be exposed to heat exposure via a water-perfused suit to increase internal body temperature by 1.5 degrees Celsius.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Change from baseline to an increase in internal body temperature of 1.5 degrees Celsius, estimated average = 90 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Measured by PET imaging with 82rubidium
|
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
|
Measured by electrocardiogram
|
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
|
Measured by automated auscultation of the brachial artery
|
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
|
Measured with a scale
|
Measured before and after heat exposure, estimated average = 120 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Daniel Gagnon, PhD, Montreal Heart Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ICM 2020-2719
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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