Back to resultsCharacterization of Myocardial Blood Flow During Heat Exposure (PET-Heat)
Primary Purpose
Hot Weather; Adverse Effect, Healthy, Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Heat exposure
Sponsored by
About this trial
This is an interventional basic science trial for Hot Weather; Adverse Effect focused on measuring Heat, PET imaging, Myocardial blood flow
Eligibility Criteria
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
Sites / Locations
- Montreal Heart Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Passive heat exposure
Arm Description
Outcomes
Primary Outcome Measures
Global myocardial blood flow
Measured by PET imaging with 82rubidium
Secondary Outcome Measures
Myocardial blood flow distribution
Measured by PET imaging with 82rubidium
Heart rate
Measured by electrocardiogram
Systolic and diastolic blood pressure
Measured by automated auscultation of the brachial artery
Body weight
Measured with a scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04549974
Brief Title
Characterization of Myocardial Blood Flow During Heat Exposure
Acronym
PET-Heat
Official Title
Characterization of the Increase and Distribution of Myocardial Blood Flow During Heat Exposure
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
August 25, 2020 (Actual)
Primary Completion Date
March 31, 2023 (Actual)
Study Completion Date
March 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montreal Heart Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hot Weather; Adverse Effect, Healthy, Coronary Artery Disease, Aging
Keywords
Heat, PET imaging, Myocardial blood flow
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Passive heat exposure
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Heat exposure
Intervention Description
Participants will be exposed to heat exposure via a water-perfused suit to increase internal body temperature by 1.5 degrees Celsius.
Primary Outcome Measure Information:
Title
Global myocardial blood flow
Description
Measured by PET imaging with 82rubidium
Time Frame
Change from baseline to an increase in internal body temperature of 1.5 degrees Celsius, estimated average = 90 minutes
Secondary Outcome Measure Information:
Title
Myocardial blood flow distribution
Description
Measured by PET imaging with 82rubidium
Time Frame
Change from baseline to an increase in internal body temperature of 1.5 degrees Celsius, estimated average = 90 minutes
Title
Heart rate
Description
Measured by electrocardiogram
Time Frame
Change from baseline to an increase in internal body temperature of 1.5 degrees Celsius, estimated average = 90 minutes
Title
Systolic and diastolic blood pressure
Description
Measured by automated auscultation of the brachial artery
Time Frame
Change from baseline to an increase in internal body temperature of 1.5 degrees Celsius, estimated average = 90 minutes
Title
Body weight
Description
Measured with a scale
Time Frame
Measured before and after heat exposure, estimated average = 120 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Gagnon, PhD
Organizational Affiliation
Montreal Heart Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montreal Heart Institute
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T1C8
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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Characterization of Myocardial Blood Flow During Heat Exposure
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