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临床试验/NCT04549974
NCT04549974已完成不适用

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

Montreal Heart Institute2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年8月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
2
主要终点
Global myocardial blood flow

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Global myocardial blood flow

时间窗: 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

次要结局

  • Myocardial blood flow distribution(Change from baseline to an increase in internal body temperature of 1.5 degrees Celsius, estimated average = 90 minutes)
  • Systolic and diastolic blood pressure(Change from baseline to an increase in internal body temperature of 1.5 degrees Celsius, estimated average = 90 minutes)
  • Heart rate(Change from baseline to an increase in internal body temperature of 1.5 degrees Celsius, estimated average = 90 minutes)
  • Body weight(Measured before and after heat exposure, estimated average = 120 minutes)

研究者

发起方
Montreal Heart Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel Gagnon

Principal Investigator

Montreal Heart Institute

研究点 (2)

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