Cardiovascular DiseasesPhase 1NCT03684213
Local Antioxidant Therapy Vasoconstriction Effects in Different Races
A Phase 1 study testing Norepinephrine + Ascorbic Acid, Norepinephrine + L-NAME and Norepinephrine + L-NAME + Ascorbic Acid in people with Cardiovascular Diseases and Cardiovascular Risk Factor, run by The University of Texas at Arlington at 1 site in United States.
Trial summary
Cardiovascular disease (CVD) afflicts nearly one-third of the adult population with all races and ethnicities represented in CVD prevalence. Unfortunately, a disparity exists such that the black population (BL) is disproportionately affected compared to other groups, including the white population (WH). Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Cardiovascular Risk Factor, Vasoconstriction
- What is being tested?
- Norepinephrine + Ascorbic Acid, Norepinephrine + L-NAME and Norepinephrine + L-NAME + Ascorbic Acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2018to 8 Jun 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Individuals (ages 18-35, both genders) will be recruited from the greater Arlington area to participate in the study.
- Must self-report both parents as either African American or Caucasian American.
Who cannot join
- Individuals who have donated more than 550 ml of blood within the past 8 weeks will not have blood drawn from them in this protocol. However, if they remain interested in the study, and otherwise meet the inclusion criteria, than we may still opt to proceed with data collection.
- Individuals with cardiovascular, neurological, and/or metabolic illnesses will be excluded from participating as well as individuals with a history of various diseases of the microvasculature including Reynaud's disease, cold-induced urticaria, cryoglobulinemia, etc.
- Subjects currently taking any prescription medications and individuals with a body mass index about 30 kg/m2) will be excluded.
- Pregnant subjects and children (i.e. younger than 18) will not be recruited for the study. Eligible females will be scheduled for days 2-7 of their menstrual cycle to account for hormonal effects on blood flow. A regular menstrual cycle is required to identify and schedule the study for the low hormone period, therefore females who lack a regular cycle will be excluded from the study. Females currently taking birth control are eligible, as long as they can be scheduled during a low-hormone "placebo" week. If their hormone do not contain a placebo week than these individuals will not be eligible for data collection. Females who are breast-feeding will also be eligible as there are no systemic or lasting effects of the proposed vasoactive agents.
- Given that smoking can affect the peripheral vasculature, current smokers and individuals who regularly smoked (>1 pack per two weeks) within the prior 2 years will be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
Science and Engineering Research and Innovation Building
Arlington, Texas, 76019
About this study
Official title: The Effect of Local Antioxidant Therapy on Racial Differences in Vasoconstriction
Cardiovascular disease (CVD) afflicts nearly one-third of the adult population with all races and ethnicities represented in CVD prevalence. Unfortunately, a disparity exists such that the black population (BL) is disproportionately affected compared to other groups, including the white population (WH). While the underlying cause of this disparity is multifactorial, vascular dysfunction (i.e., impaired vasodilation and/or augmented vasoconstriction) is a key contributor. As has been previously observed, BL exhibit a heightened vasoconstrictor response to both pharmacological (e.g., alpha-adrenergic receptor agonists) and environmental (e.g., cold pressor test) stimuli compared to their WH counterparts. Additionally, reactive oxygen species (ROS) and the subsequent reduction in nitric oxide (NO) bioavailability may partially mediate this response. Our laboratory has recently observed (UTA IRB 2016-0268) that the small blood vessels in the skin (cutaneous microvasculature) in BL, but otherwise healthy individuals, produce an impaired blood flow response to local heating when compared to age-, body mass index (BMI)-, and gender-matched WH. However, pre-treatment of the cutaneous microvasculature with various antioxidants abolishes this skin blood flow difference. These antioxidant drugs inhibit possible sources of ROS, which, as mentioned, maybe mediating the heightened vasoconstrictor response in BL. However, this has not been investigated in this population and thus remains unknown. Therefore, the purpose of this study proposal is to test the following hypotheses: 1) BL will have a greater reduction in cutaneous blood flow in response to local administration of Norepinephrine (alpha1-adrenergic and alpha 2-adrenergic receptor agonist) relative to WH. 2) This greater reduction in the BL population will be related to elevated oxidative stress and subsequent reduction in bioavailability of the potent vasodilator Nitric oxide.
Read the detailed description
Collectively, these studies will provide novel data and insight into the impact of heightened vasoconstrictor responses in BL on vascular function. Interested participants will be asked to come in the fasted state (a minimum of 3 hr since the last meal) and to have refrained from alcohol, caffeine, and physical activity for 24 hr. We will first review the inclusion/exclusion criteria and discuss the informed consent form including an oral explanation of the study purpose, experimental procedures and measurements, and potential risks and benefits associated with participation. Prior to any screening/testing, all subjects will provide written, informed consent. A medical health history questionnaire will then be completed by the subject and subsequently reviewed by the research team to determine eligibility. For the qualified participants, to test the aforementioned hypotheses, we will use laser Doppler to assess the skin blood flow response to local administration of the sympathomimetic drug-norepinephrine which is an alpha-1 and alpha-2 -adrenergic receptor agonist. Each participant will be instrumented with four cutaneous microdialysis fibers in the skin of the non-dominant forearm. Each of the following conditions will be randomly assigned to an individual microdialysis site. Experimental sites will then be infused with their respective vasoactive agents at a rate of 2 μl/min for a 30 min wash-in period. Site 1: This site will serve as the control site and will receive lactated Ringer's (saline solution). Site2: This site will receive 20 mM L-NAME (Nω-Nitro-L-arginine methyl ester hydrochloride, Sigma Aldrich) to inhibit nitric oxide production by nitric oxide synthase. This site will then be infused with no more than 10mM of norepinephrine to elicit vasoconstriction. Site 3: This site will receive 10 mM Ascorbic Acid which serves as a non-selective antioxidant. Ascorbic acid is commonly known as Vitamin C. This site will then be infused with no more than 10mM of norepinephrine to elicit vasoconstriction. Site 4: This site will receive a combination of 20mM L-NAME + 10 mM ascorbic acid. This site will then be infused with incremental doses of 10-8M - 10-2M of norepinephrine to elicit vasoconstriction. This dose and approach is commonly utilized in these types of studies. After the 30-min wash-in period, 15-min of baseline data will be collected with local heaters set to 33°C(91.4°F). After 15 min of baseline data collection, the perfusate at each site will be switched to various concentrations of norepinephrine combined with the respective vasoactive agent for each site-incremental doses of 10-8M - 10-2M (no more than 10mM(10-2M) at a rate of 2 μl/min for a brief period (no more than 6-min each dose) to quantify the level of vasoconstriction at each site. The order of the procedure will be as follows: 1. Instrumentation with membranes. 2. Wash-in perfusion with vasoactive agent at respective site (each site will receive its respective vasoactive agent simultaneously). Temperature set at 33°C(91.4°F). 3. Baseline data collection. Temperature set at 33 degree C(91.4°F). 4. Switch to Norepinephrine + combined vasoactive agent (for each respective site) infusion. Temperature set at 33 degree C(91.4°F). 5. Repeat step 4 for each concentration of norepinephrine used. As commonly done in these types of studies there will not be any flushes of Ringer's solution between doses of NE. In addition we will also measure blood flow in the brachial artery using Doppler ultrasound during resting conditions as well as during a standard flow mediated dilation (FMD) protocol. This includes inflating a blood pressure cuff to suprasystolic pressures (pressure slightly above the participant's systolic blood pressure) for 5 min and making continuous blood flow measures before and after release of the cuff. This will be performed on the upper arm in the brachial artery. This is a standard procedure used in numerous clinical investigations to estimate endothelial function with no reports of injury or adverse events. Subject Participation: During the course of the study, a subject may decide not to participate in a particular experimental measurement or procedure and therefore, this portion of the protocol will not be completed. However, all other measurements and procedures will be performed. This will not affect the scientific value of the subject's participation as each experimental measurement and procedure provides important and in most cases independent information.
- Being tested
- Control (Norepinephrine), Norepinephrine + Ascorbic Acid, Norepinephrine + L-NAME, Norepinephrine + L-NAME + Ascorbic Acid
- Keywords
- Racial Differences, Oxidative Stress, Antioxidant, Microvasculature
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control (Norepinephrine)Drug
This intervention is aimed at assessing the vascular responsiveness to norepinephrine, an alpha 1-agonist, in white and black men and women across a series of ascending dose concentrations.
Norepinephrine + Ascorbic AcidDrug
This intervention is meant to globally assess the impact of oxidative stress on vasoconstrictor responses by scavenging numerous oxidative molecules.
Norepinephrine + L-NAMEDrug
This intervention is meant to assess the impact of endothelium-derived nitric oxide on vasoconstrictor responses by inhibiting production of this source of nitric oxide.
Norepinephrine + L-NAME + Ascorbic AcidDrug
This intervention is meant to assess the combined impact of scavenging oxidative stress and inhibiting endothelium-derived nitric oxide on vasoconstrictor responses.
| Study group | Role | What they receive |
|---|---|---|
| Control (Norepinephrine) | Active comparator | Subjects will be administered norepinephrine at varying concentrations (10^-2 to 10^-8 M phenylephrine) at a rate of 2 microliters/minute for 10 minutes at each dose to construct a dose-response curve. Receives: Drug: Control (Norepinephrine) |
| Norepinephrine + Ascorbic Acid | Experimental | Subjects will be coinfused with the same norepinephrine concentrations as the control arm and ascorbic acid (Vitamin C; 10 mM) at the same rate and for the same time as the control arm. Receives: Drug: Norepinephrine + Ascorbic Acid |
| Norepinephrine + L-NAME | Experimental | Subjects will be coinfused with the same norepinephrine concentrations as the control arm and L-NAME (Nω-Nitro-L-arginine methyl ester hydrochloride; 20 mM) at the same rate and for the same time as the control arm. Receives: Drug: Norepinephrine + L-NAME |
| Norepinephrine + L-NAME + Ascorbic Acid | Experimental | Subjects will be coinfused with the same norepinephrine concentrations as the control arm and combined L-NAME (Nω-Nitro-L-arginine methyl ester hydrochloride; 20 mM) and ascorbic acid (Vitamin C; 10 mM) at the same rate and for the same time as the control arm. Receives: Drug: Norepinephrine + L-NAME + Ascorbic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vasoconstrictor Responsiveness to Norepinephrine using Laser Doppler Fluxmetry
Establish heightened vasoconstriction to norepinephrine stimulation in black men and women with a focus on black women. Following the local infusion of norepinephrine, the changes in blood flux will be quantified using laser Doppler fluxmetry. All changes in flux will be normalized and reported as a percentage of baseline flux.
Measured: Through study completion, an average of 1 Year
Role of Oxidative Stress in Heightened Vasoconstriction using Laser Doppler Fluxmetry
Determine to what degree global oxidative stress and differences in endothelial nitric oxide play a role in heightened vasoconstriction. Following the local infusion of norepinephrine combined with either Ascorbic Acid, L-NAME, or L-NAME with Ascorbic Acid, the changes in blood flux will be quantified using laser Doppler fluxmetry. All changes in flux will be normalized and reported as a percentage of baseline flux.
Measured: Through study completion, an average of 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start15 Oct 2018
- Primary completion15 May 2024
- Study completion8 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Each subject has one control site and three experimental sites concurrently tested within the same study using intradermal microdialysis on the dorsal forearm.
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas at Arlington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Brothers, The University of Texas at Arlington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03684213
- Sponsor's protocol ID
- 2018-0647
- Status last verified
- Jun 2024
- First submitted
- 17 Sep 2018
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Local Antioxidant Therapy on Racial Differences in Vasoconstriction
- ClinicalTrials.gov ID
- NCT03684213
- Acronym / sponsor ID
- 2018-0647
- Keywords
- Racial Differences, Oxidative Stress, Antioxidant, Microvasculature
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- The University of Texas at ArlingtonUniversity, hospital or other
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 8 Jun 2024 (actual)
- First posted
- 25 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cardiovascular disease (CVD) afflicts nearly one-third of the adult population with all races and ethnicities represented in CVD prevalence. Unfortunately, a disparity exists such that the black population (BL) is disproportionately affected compared to other groups, including the white population (WH). While the underlying cause of this disparity is multifactorial, vascular dysfunction (i.e., impaired vasodilation and/or augmented vasoconstriction) is a key contributor. As has been previously observed, BL exhibit a heightened vasoconstrictor response to both pharmacological (e.g., alpha-adrenergic receptor agonists) and environmental (e.g., cold pressor test) stimuli compared to their WH counterparts. Additionally, reactive oxygen species (ROS) and the subsequent reduction in nitric oxide (NO) bioavailability may partially mediate this response. Our laboratory has recently observed (UTA IRB 2016-0268) that the small blood vessels in the skin (cutaneous microvasculature) in BL, but otherwise healthy individuals, produce an impaired blood flow response to local heating when compared to age-, body mass index (BMI)-, and gender-matched WH. However, pre-treatment of the cutaneous microvasculature with various antioxidants abolishes this skin blood flow difference. These antioxidant drugs inhibit possible sources of ROS, which, as mentioned, maybe mediating the heightened vasoconstrictor response in BL. However, this has not been investigated in this population and thus remains unknown. Therefore, the purpose of this study proposal is to test the following hypotheses: 1) BL will have a greater reduction in cutaneous blood flow in response to local administration of Norepinephrine (alpha1-adrenergic and alpha 2-adrenergic receptor agonist) relative to WH. 2) This greater reduction in the BL population will be related to elevated oxidative stress and subsequent reduction in bioavailability of the potent vasodilator Nitric oxide.
Detailed description
Collectively, these studies will provide novel data and insight into the impact of heightened vasoconstrictor responses in BL on vascular function. Interested participants will be asked to come in the fasted state (a minimum of 3 hr since the last meal) and to have refrained from alcohol, caffeine, and physical activity for 24 hr. We will first review the inclusion/exclusion criteria and discuss the informed consent form including an oral explanation of the study purpose, experimental procedures and measurements, and potential risks and benefits associated with participation. Prior to any screening/testing, all subjects will provide written, informed consent. A medical health history questionnaire will then be completed by the subject and subsequently reviewed by the research team to determine eligibility. For the qualified participants, to test the aforementioned hypotheses, we will use laser Doppler to assess the skin blood flow response to local administration of the sympathomimetic drug-norepinephrine which is an alpha-1 and alpha-2 -adrenergic receptor agonist. Each participant will be instrumented with four cutaneous microdialysis fibers in the skin of the non-dominant forearm. Each of the following conditions will be randomly assigned to an individual microdialysis site. Experimental sites will then be infused with their respective vasoactive agents at a rate of 2 μl/min for a 30 min wash-in period. Site 1: This site will serve as the control site and will receive lactated Ringer's (saline solution). Site2: This site will receive 20 mM L-NAME (Nω-Nitro-L-arginine methyl ester hydrochloride, Sigma Aldrich) to inhibit nitric oxide production by nitric oxide synthase. This site will then be infused with no more than 10mM of norepinephrine to elicit vasoconstriction. Site 3: This site will receive 10 mM Ascorbic Acid which serves as a non-selective antioxidant. Ascorbic acid is commonly known as Vitamin C. This site will then be infused with no more than 10mM of norepinephrine to elicit vasoconstriction. Site 4: This site will receive a combination of 20mM L-NAME + 10 mM ascorbic acid. This site will then be infused with incremental doses of 10-8M - 10-2M of norepinephrine to elicit vasoconstriction. This dose and approach is commonly utilized in these types of studies. After the 30-min wash-in period, 15-min of baseline data will be collected with local heaters set to 33°C(91.4°F). After 15 min of baseline data collection, the perfusate at each site will be switched to various concentrations of norepinephrine combined with the respective vasoactive agent for each site-incremental doses of 10-8M - 10-2M (no more than 10mM(10-2M) at a rate of 2 μl/min for a brief period (no more than 6-min each dose) to quantify the level of vasoconstriction at each site. The order of the procedure will be as follows: 1. Instrumentation with membranes. 2. Wash-in perfusion with vasoactive agent at respective site (each site will receive its respective vasoactive agent simultaneously). Temperature set at 33°C(91.4°F). 3. Baseline data collection. Temperature set at 33 degree C(91.4°F). 4. Switch to Norepinephrine + combined vasoactive agent (for each respective site) infusion. Temperature set at 33 degree C(91.4°F). 5. Repeat step 4 for each concentration of norepinephrine used. As commonly done in these types of studies there will not be any flushes of Ringer's solution between doses of NE. In addition we will also measure blood flow in the brachial artery using Doppler ultrasound during resting conditions as well as during a standard flow mediated dilation (FMD) protocol. This includes inflating a blood pressure cuff to suprasystolic pressures (pressure slightly above the participant's systolic blood pressure) for 5 min and making continuous blood flow measures before and after release of the cuff. This will be performed on the upper arm in the brachial artery. This is a standard procedure used in numerous clinical investigations to estimate endothelial function with no reports of injury or adverse events. Subject Participation: During the course of the study, a subject may decide not to participate in a particular experimental measurement or procedure and therefore, this portion of the protocol will not be completed. However, all other measurements and procedures will be performed. This will not affect the scientific value of the subject's participation as each experimental measurement and procedure provides important and in most cases independent information.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Each subject has one control site and three experimental sites concurrently tested within the same study using intradermal microdialysis on the dorsal forearm.
| Arm | Type | Receives |
|---|---|---|
| Control (Norepinephrine) | Active comparator | Drug: Control (Norepinephrine)Subjects will be administered norepinephrine at varying concentrations (10^-2 to 10^-8 M phenylephrine) at a rate of 2 microliters/minute for 10 minutes at each dose to construct a dose-response curve. |
| Norepinephrine + Ascorbic Acid | Experimental | Drug: Norepinephrine + Ascorbic AcidSubjects will be coinfused with the same norepinephrine concentrations as the control arm and ascorbic acid (Vitamin C; 10 mM) at the same rate and for the same time as the control arm. |
| Norepinephrine + L-NAME | Experimental | Drug: Norepinephrine + L-NAMESubjects will be coinfused with the same norepinephrine concentrations as the control arm and L-NAME (Nω-Nitro-L-arginine methyl ester hydrochloride; 20 mM) at the same rate and for the same time as the control arm. |
| Norepinephrine + L-NAME + Ascorbic Acid | Experimental | Drug: Norepinephrine + L-NAME + Ascorbic AcidSubjects will be coinfused with the same norepinephrine concentrations as the control arm and combined L-NAME (Nω-Nitro-L-arginine methyl ester hydrochloride; 20 mM) and ascorbic acid (Vitamin C; 10 mM) at the same rate and for the same time as the control arm. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Individuals (ages 18-35, both genders) will be recruited from the greater Arlington area to participate in the study.
- Must self-report both parents as either African American or Caucasian American.
Key exclusion criteria (5 listed)
- Individuals who have donated more than 550 ml of blood within the past 8 weeks will not have blood drawn from them in this protocol. However, if they remain interested in the study, and otherwise meet the inclusion criteria, than we may still opt to proceed with data collection.
- Individuals with cardiovascular, neurological, and/or metabolic illnesses will be excluded from participating as well as individuals with a history of various diseases of the microvasculature including Reynaud's disease, cold-induced urticaria, cryoglobulinemia, etc.
- Subjects currently taking any prescription medications and individuals with a body mass index about 30 kg/m2) will be excluded.
- Pregnant subjects and children (i.e. younger than 18) will not be recruited for the study. Eligible females will be scheduled for days 2-7 of their menstrual cycle to account for hormonal effects on blood flow. A regular menstrual cycle is required to identify and schedule the study for the low hormone period, therefore females who lack a regular cycle will be excluded from the study. Females currently taking birth control are eligible, as long as they can be scheduled during a low-hormone "placebo" week. If their hormone do not contain a placebo week than these individuals will not be eligible for data collection. Females who are breast-feeding will also be eligible as there are no systemic or lasting effects of the proposed vasoactive agents.
- Given that smoking can affect the peripheral vasculature, current smokers and individuals who regularly smoked (>1 pack per two weeks) within the prior 2 years will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control (Norepinephrine)This intervention is aimed at assessing the vascular responsiveness to norepinephrine, an alpha 1-agonist, in white and black men and women across a series of ascending dose concentrations. | Drug | Control (Norepinephrine) |
| Norepinephrine + Ascorbic AcidThis intervention is meant to globally assess the impact of oxidative stress on vasoconstrictor responses by scavenging numerous oxidative molecules. | Drug | Norepinephrine + Ascorbic Acid |
| Norepinephrine + L-NAMEThis intervention is meant to assess the impact of endothelium-derived nitric oxide on vasoconstrictor responses by inhibiting production of this source of nitric oxide. | Drug | Norepinephrine + L-NAME |
| Norepinephrine + L-NAME + Ascorbic AcidThis intervention is meant to assess the combined impact of scavenging oxidative stress and inhibiting endothelium-derived nitric oxide on vasoconstrictor responses. | Drug | Norepinephrine + L-NAME + Ascorbic Acid |
Primary outcome
Vasoconstrictor Responsiveness to Norepinephrine using Laser Doppler Fluxmetry
Time frame: Through study completion, an average of 1 Year
Establish heightened vasoconstriction to norepinephrine stimulation in black men and women with a focus on black women. Following the local infusion of norepinephrine, the changes in blood flux will be quantified using laser Doppler fluxmetry. All changes in flux will be normalized and reported as a percentage of baseline flux.
Role of Oxidative Stress in Heightened Vasoconstriction using Laser Doppler Fluxmetry
Time frame: Through study completion, an average of 1 Year
Determine to what degree global oxidative stress and differences in endothelial nitric oxide play a role in heightened vasoconstriction. Following the local infusion of norepinephrine combined with either Ascorbic Acid, L-NAME, or L-NAME with Ascorbic Acid, the changes in blood flux will be quantified using laser Doppler fluxmetry. All changes in flux will be normalized and reported as a percentage of baseline flux.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Norepinephrine + Ascorbic Acid, Norepinephrine + L-NAME and Norepinephrine + L-NAME + Ascorbic Acid in people with Cardiovascular Diseases and Cardiovascular Risk Factor, run by The University of Texas at Arlington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vasoconstrictor Responsiveness to Norepinephrine using Laser Doppler Fluxmetry (time frame: Through study completion, an average of 1 Year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.