NCT04549974

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

August 25, 2020

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 16, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

May 8, 2023

Status Verified

May 1, 2023

Enrollment Period

2.6 years

First QC Date

August 25, 2020

Last Update Submit

May 5, 2023

Conditions

Hot Weather; Adverse EffectHealthyCoronary Artery DiseaseAging

Keywords

HeatPET imagingMyocardial blood flow

Outcome Measures

Primary Outcomes (1)

  • Global myocardial blood flow

    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 Outcomes (4)

  • Myocardial blood flow distribution

    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

  • Systolic and diastolic blood pressure

    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

Study Arms (1)

Passive heat exposure

EXPERIMENTAL
Other: Heat exposure

Interventions

Heat exposureOTHER

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

Passive heat exposure

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montreal Heart Institute

Montreal, Quebec, H1T1C8, Canada

Location

Related Publications (1)

  • 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.

    PMID: 38857500DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Daniel Gagnon, PhD

    Montreal Heart Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 25, 2020

First Posted

September 16, 2020

Study Start

August 25, 2020

Primary Completion

March 31, 2023

Study Completion

March 31, 2023

Last Updated

May 8, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)