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Vasodilator
Acetylcholine for Blood Vessel Function (CAP NOVA Trial)
Phase < 1
Recruiting
Research Sponsored by University of Iowa
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged 18-30 years
Be between 18 and 65 years old
Must not have
Unstable or diagnosed chronic clinical disease including cardiovascular, metabolic, renal, hepatic, autonomic, autoimmune, or dermatological disease (e.g., hypertension, heart disease, diabetes, hyperlipidemia, psoriasis)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline study visit (average of 4 hours)
Awards & highlights
No Placebo-Only Group
Summary
This trial compares two methods of assessing blood vessel function in the skin by heating it rapidly. One method heats the skin to 42°C, while the other heats it to 39°C, which is
Who is the study for?
This trial is for young adults aged 18-30 who are interested in participating in a study examining blood vessel function in the skin. The study involves local heating of the skin and filling out surveys related to lifestyle factors like sleep, physical activity, and stress.
What is being tested?
The trial is testing how well blood vessels in the skin respond to heat as a way to assess nitric oxide-dependent dilation. It compares two different temperatures (39°C and 42°C) using intradermal microdialysis—a technique that delivers drugs directly into the skin.
What are the potential side effects?
Since this study uses non-invasive techniques with localized effects, side effects may be minimal but could include mild discomfort or redness at the site of heating or drug delivery.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 30 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any unstable or chronic diseases like heart disease or diabetes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline study visit (average of 4 hours)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline study visit (average of 4 hours)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Microvascular blood flow response to acetylcholine
Microvascular blood flow response to local heat (39 degrees Celsius)
Microvascular blood flow response to local heat (42 degrees Celsius)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: assessment of microvascular endothelial functionExperimental Treatment1 Intervention
The investigators use intradermal microdialysis to deliver acetylcholine, L-NAME, and acetylcholine + L-NAME to the cutaneous microvasculature.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acetylcholine
2013
Completed Phase 2
~220
Find a Location
Who is running the clinical trial?
University of IowaLead Sponsor
471 Previous Clinical Trials
894,605 Total Patients Enrolled