- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06842784
Impact of Extreme Heat on Myocardial Blood Flow and Flow Reserve in Young and Older Adults
February 18, 2025 updated by: James MacNamara, University of Texas Southwestern Medical Center
Extreme heat causes a disproportionate number of hospitalizations and deaths in older adults relative to any other age group.
Importantly, many hospitalizations and deaths are primarily due to cardiovascular events such as myocardial infarction.
Previous data indicate that older adults have attenuated skin blood flow and sweating responses when exposed to heat, resulting greater increase in core body temperature.
Despite these observations, relatively little is known about the risk for myocardial ischemia potentially contributing to the aforementioned higher morbidity and mortality in older adults during heat waves.
The broad objective of this work is to determine the impact of ambient heat exposure on myocardial blood flow and flow reserve in young and older adults.
Aim 1 will test the hypothesis that older adults exhibit attenuated myocardial flow reserve compared to young adults during heat stress.
Aim 2 will determine if the percent of maximal myocardial flow reserve (assess via vasodilator stress) during heat exposure is higher in older adults compared to young adults.
The expected outcome from this body of work will improve our understanding of the consequences of aging on cardiovascular responses to ambient heat stress.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
24
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zachary McKenna, PhD
- Phone Number: 214-345-6557
- Email: ZacharyMckenna@texashealth.org
Study Contact Backup
- Name: Taysom Wallace, MS
- Phone Number: 214-345-5022
- Email: taysomwallace@texashealth.org
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75231
- Recruiting
- Texas Health Presbyterian Hospital Dallas
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
The study population will be healthy younger and older individuals identified from the general population.
Description
Inclusion Criteria:
- Healthy male and female individuals
- 18-35 years or 65+ years of age
- Free of any underlying moderate to serious medical conditions
Exclusion Criteria:
- Known heart disease; other chronic medical conditions requiring regular medical therapy including cancer, diabetes, neurological diseases, uncontrolled hypertension, and uncontrolled hypercholesterolemia.
- Taking of any medications (such as beta blockers and non-dihydropyridine calcium channel blockers) that have known influences on either cardiac function or sweating responses.
- Abnormalities detected on routine screening.
- Current smokers, as well as individuals who regularly smoked within the past 3 years.
- Body mass index of greater than 30 kg/m^2
- Pregnant individuals
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Older participants
Individuals aged 65 years or older
|
3-hour ambient heating in 44°C and 20% relative humidity
|
|
Young participants
Individuals aged 18-39 years
|
3-hour ambient heating in 44°C and 20% relative humidity
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Myocardial flow reserve
Time Frame: The difference in the change from baseline to a vasodilator stress test and the change from baseline to after 3-hours of heat stress.
|
Measured via myocardial contrast echocardiography.
|
The difference in the change from baseline to a vasodilator stress test and the change from baseline to after 3-hours of heat stress.
|
|
Myocardial blood flow
Time Frame: The change from baseline to after 3 hours of heat stress.
|
Measured via myocardial contrast echocardiography.
|
The change from baseline to after 3 hours of heat stress.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Core temperature
Time Frame: The change from baseline to after 3 hours of heat stress..
|
Measured via ingestible telemetric pill.
|
The change from baseline to after 3 hours of heat stress..
|
|
Indices of left and right ventricular function
Time Frame: At baseline and after 3 hours of heat stress.
|
Measured via echocardiography.
|
At baseline and after 3 hours of heat stress.
|
|
Heart rate
Time Frame: At baseline, during exercise- after 20 minutes and 2 hours in the heat, and at rest after 3 hours of heat stress.
|
Measured via electrocardiogram.
|
At baseline, during exercise- after 20 minutes and 2 hours in the heat, and at rest after 3 hours of heat stress.
|
|
Blood pressure
Time Frame: At baseline, during exercise- after 20 minutes and 2 hours in the heat, and at rest after 3 hours of heat stress.
|
Measured via automated auscultation of the brachial artery.
|
At baseline, during exercise- after 20 minutes and 2 hours in the heat, and at rest after 3 hours of heat stress.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 3, 2025
Primary Completion (Estimated)
February 1, 2026
Study Completion (Estimated)
February 1, 2027
Study Registration Dates
First Submitted
February 18, 2025
First Submitted That Met QC Criteria
February 18, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 18, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU_2019_1759_MCE
- 1R01AG069005 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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