Cardiovascular DiseaseNCT01037465
ROS Signaling in Endothelial Function
A study testing N-acetylcysteine in people with Cardiovascular Disease, run by Boston University at 1 site in United States.
Trial summary
The vascular endothelium (inner lining of cells in blood vessels) normally prevents vasospasm and thrombosis by producing nitric oxide and other regulatory substances. In patients with atherosclerosis, endothelial function is impaired. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- N-acetylcysteine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to 26 Mar 2016
- Phase
- Interventional
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sex: Male and Female subjects.
- Age range: 21-65 years old.
- Disease status: No acute, chronic, or debilitating medical condition or use of prescribed medications.
- Willingness and ability to provide written informed consent and the ability to understand, to participate and to comply with the study requirements.
Who cannot join
- Women with a positive urine beta HCG pregnancy test and lactating women.
- Blood pressure greater than 140/90 mmHg; serum LDL cholesterol greater than 160 mg/dl; fasting blood sugar greater than 110 mg/dl.
- History of any cigarette smoking within one year of the study.
- Clinical history of any acute, chronic, or debilitating medical condition, including liver disease and peptic ulcer disease.
- Treatment with an investigational new drug within the last 30 days.
- History of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study.
Trial locations and contacts
1 site in 1 country.
About this study
The vascular endothelium (inner lining of cells in blood vessels) normally prevents vasospasm and thrombosis by producing nitric oxide and other regulatory substances. In patients with atherosclerosis, endothelial function is impaired. Excess production of reactive oxygen species (free radicals) contribute to endothelial dysfunction in atherosclerosis, and some prior studies have shown a beneficial effect of antioxidant treatment on endothelial function in patients with coronary artery disease. On the other hand, reactive oxygen species may be required for normal endothelial function and antioxidant supplements failed to show a benefit in large clinical trials. The effect of antioxidant treatment on endothelial function in healthy subjects is unknown. The present study will test the hypothesis that scavenging reactive species might reduce endothelium-dependent vasodilation in healthy subjects.
The study is a randomized, double-blind, placebo-controlled crossover study. Participants will receive 2.4 grams of oral NAC or similar-appearing placebo during the first visit, and then will cross over to the alternative treatment (NAC or placebo) for the second and final visit. We will examine endothelial function before and after treatment on each visit.
- Conditions
- Cardiovascular Disease
- Being tested
- N-acetylcysteine, Placebo
- Keywords
- endothelium, cell signaling, N-acetylcysteine, reactive oxygen species
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetylcysteineDrug
N-acetylcysteine
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| N-acetylcysteine | Active comparator | N-acetylcysteine Receives: Drug: N-acetylcysteine |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brachial artery flow-mediated dilation
Measured: 4 hours
Secondary outcomes (1)
Blood markers of antioxidant capacity
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2009 (estimated)
- Study startSep 2008
- Primary completionDec 2015
- Study completion26 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naomi M Hamburg, Boston University
- Investigators
- Naomi Hamburg, MD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01037465
- Sponsor's protocol ID
- H-26547
- Status last verified
- Mar 2017
- First submitted
- 19 Dec 2009
- Last updated
- 10 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROS Signaling in Endothelial Function
- ClinicalTrials.gov ID
- NCT01037465
- Acronym / sponsor ID
- H-26547
- Conditions
- Cardiovascular Disease
- Keywords
- endothelium, cell signaling, N-acetylcysteine, reactive oxygen species
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Dec 2015 (actual)
- Study completion
- 26 Mar 2016 (actual)
- First posted
- 23 Dec 2009 (estimated)
- 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.
The vascular endothelium (inner lining of cells in blood vessels) normally prevents vasospasm and thrombosis by producing nitric oxide and other regulatory substances. In patients with atherosclerosis, endothelial function is impaired. Excess production of reactive oxygen species (free radicals) contribute to endothelial dysfunction in atherosclerosis, and some prior studies have shown a beneficial effect of antioxidant treatment on endothelial function in patients with coronary artery disease. On the other hand, reactive oxygen species may be required for normal endothelial function and antioxidant supplements failed to show a benefit in large clinical trials. The effect of antioxidant treatment on endothelial function in healthy subjects is unknown. The present study will test the hypothesis that scavenging reactive species might reduce endothelium-dependent vasodilation in healthy subjects.
The study is a randomized, double-blind, placebo-controlled crossover study. Participants will receive 2.4 grams of oral NAC or similar-appearing placebo during the first visit, and then will cross over to the alternative treatment (NAC or placebo) for the second and final visit. We will examine endothelial function before and after treatment on each visit.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N-acetylcysteine | Active comparator | Drug: N-acetylcysteineN-acetylcysteine |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Sex: Male and Female subjects.
- Age range: 21-65 years old.
- Disease status: No acute, chronic, or debilitating medical condition or use of prescribed medications.
- Willingness and ability to provide written informed consent and the ability to understand, to participate and to comply with the study requirements.
Key exclusion criteria (6 listed)
- Women with a positive urine beta HCG pregnancy test and lactating women.
- Blood pressure greater than 140/90 mmHg; serum LDL cholesterol greater than 160 mg/dl; fasting blood sugar greater than 110 mg/dl.
- History of any cigarette smoking within one year of the study.
- Clinical history of any acute, chronic, or debilitating medical condition, including liver disease and peptic ulcer disease.
- Treatment with an investigational new drug within the last 30 days.
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 |
|---|---|---|
| N-acetylcysteineN-acetylcysteine | Drug | N-acetylcysteine |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Brachial artery flow-mediated dilation
Time frame: 4 hours
1 secondary outcome
Blood markers of antioxidant capacity
Time frame: 4 hours
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 10 Mar 2017.
- 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.
Naomi Hamburg, MD principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing N-acetylcysteine in people with Cardiovascular Disease, run by Boston University 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 4 inclusion and 6 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 10 Mar 2017. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Brachial artery flow-mediated dilation (time frame: 4 hours). 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 10 Mar 2017; AzTrials last refreshed its copy on 2 Nov 2026.