Autonomic Control of the Circulation and VDR (NCT03513770) | Clinical Trial Compass
RecruitingEarly Phase 1
Autonomic Control of the Circulation and VDR
United States18 participantsStarted 2019-08-14
Plain-language summary
The study objective of this project is to examine the mechanisms of the venous distension reflex (VDR) in humans. We hypothesize that COX blockade with ketorolac tromethamine, an intravenous NSAID, will attenuate the muscle sympathetic nerve activity (MSNA) response to limb venous distension. To gain further insight into whether the COX byproducts directly stimulate chemically-sensitive afferents, or enable venodilation and indirectly evoke afferent stimulation, we will measure vein size using 3T MRI during venous distention with and without ketorolac infusions.
Who can participate
Age range
21 Years – 35 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* Are capable of giving informed consent
* Are any race or ethnicity
* Are fluent in written and spoken English
* Have a satisfactory history and physical exam to meet inclusion/exclusion criteria
* Are free of acute or chronic medical conditions
* Are 21 - 35 years of age (inclusive)
* Weigh over 50 kg
Exclusion Criteria
* Are less than 21 or over 35 years of age
* Are Pregnant or nursing women
* Are prisoners or institutionalized individuals or unable to consent
* Any chronic diseases (hypertension, heart, lung, neuromuscular disease, kidney disease, diabetes or cancer).
* Are taking medications that may affect their cardiovascular or nervous system
* Has taken an NSAID within 48 hours of any visit (visit will need to be rescheduled)
* Has never taken NSAIDs and therefore would not know if they are allergic to it
* Have a supine BP \>140/90 mmHg
* Have known allergy to ibuprofen-like drugs (NSAIDS) or aspirin
* Have history of asthma or nasal polyps
* Have history of GI bleeding or ulcers
* Subjects with ferromagnetic metal implants
* Subjects who are claustrophobic
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Microneurography (MSNA)
Timeframe: Recorded continuously during the 3-4 hour study visit
2
Vein size with MRI
Timeframe: Recorded continuously during the 3-4 hour study visit