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Completed

NCT Number: NCT04549974

Characterization 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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montreal Heart Institute

Montreal, Quebec, H1T1C8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Heat exposure

Other

Participants will be exposed to heat exposure via a water-perfused suit to increase internal body temperature by 1.5 degrees Celsius.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Body weight

    Time frame: Measured before and after heat exposure, estimated average = 120 minutes

    Measured with a scale

Sponsors and collaborators

Lead sponsor

Montreal Heart Institute

Other

Registry information

Official study title

Characterization of the Increase and Distribution of Myocardial Blood Flow During Heat Exposure

Acronym: PET-Heat

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Sep 16, 2020
Registry last updated
May 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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