Contrast AgentPhase 4NCT01895699
The Effect of Contrast Agent on Endothelial Function in Healthy Men
A Phase 4 study testing Contrast agent in people with Contrast Agent and Endothelial Function, run by Xiang Guang-da at 1 site in China.
Trial summary
Contrast medium is essential for diagnosis of many diseases. However, recent studies showed that contrast agents can induce renal injury and is associated with poor long-term clinical outcome, especially in diabetes. To date, no data are available on the relationship between contrast medium and endothelial function. Read more about this study
- Who is it for?
- Ages 20 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Contrast Agent, Endothelial Function, Cytokines
- What is being tested?
- Contrast agent
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jul 2013to Jul 2015
- Phase
- Phase 4
- 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 20 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy men
- 20 yr < = age < = 30 yr
- 20 < = body mass index < = 25
Who cannot join
- age < 20 yr or > 30 yr
- dysfunction for liver, renal, and heart.
- other diseases such as diabetes, hypertension, thyroid disease
Trial locations and contacts
1 site in 1 country.
About this study
Contrast medium is essential for diagnosis of many diseases. However, recent studies showed that contrast agents can induce renal injury and is associated with poor long-term clinical outcome, especially in diabetes. To date, no data are available on the relationship between contrast medium and endothelial function. Endothelial dysfunction is known to precede atherosclerosis and is considered a risk marker for future development of cardiovascular disease. Therefore, we hypothesized that contrast agents may induce endothelial dysfunction in healthy men. In addition, we hypothesized that contrast induced endothelial dysfunction via free radicals. Thus, we also test alpha-lipoic acid whether or not protect endothelial dysfunction induced by contrast agents.
- Conditions
- Contrast Agent, Endothelial Function, Cytokines, Apoptosis of Endothelial Progenitor Cell, Free Radical, Alpha-lipoic Acid
- Being tested
- Contrast agent
- Keywords
- Contrast agent, endothelium, Free radical, Alpha lipoic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast agentOther
| Study group | Role | What they receive |
|---|---|---|
| contrast group (Ioversol) | Experimental | Each individual will be given 80 ml Ioversol via intravenous injection within 5 minutes Receives: Other: Contrast agent |
| Placebo group | Placebo comparator | Not described |
| alpha-lipoic acid group | Other | Alpha-lipoic acid 600 mg in 0.9% sodium chloride 250 ml was administrated 1 hour before contrast agents via venous. and only 0.9% sodium chloride 250 ml was administrated for other 2 groups. Receives: Other: Contrast agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
The endothelial dysfunction and the protective role of alpha-lipoic acid
Measured: 6 months
Secondary outcomes (1)
The apoptosis of endothelial progenitor cell
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contrast AgentStudies 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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiang Guang-da
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiang Guang-da, Wuhan General Hospital of Guangzhou Military Command
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01895699
- Sponsor's protocol ID
- 2013Wze033
- Status last verified
- Aug 2015
- First submitted
- 4 Jul 2013
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Contrast Agent on Endothelial Function in Healthy Men
- ClinicalTrials.gov ID
- NCT01895699
- Acronym / sponsor ID
- 2013Wze033
- Conditions
- Contrast Agent, Endothelial Function, Cytokines, Apoptosis of Endothelial Progenitor Cell, Free Radical, Alpha-lipoic Acid
- Keywords
- Contrast agent, endothelium, Free radical, Alpha lipoic acid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Xiang Guang-daUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 10 Jul 2013 (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.
Contrast medium is essential for diagnosis of many diseases. However, recent studies showed that contrast agents can induce renal injury and is associated with poor long-term clinical outcome, especially in diabetes. To date, no data are available on the relationship between contrast medium and endothelial function. Endothelial dysfunction is known to precede atherosclerosis and is considered a risk marker for future development of cardiovascular disease. Therefore, we hypothesized that contrast agents may induce endothelial dysfunction in healthy men. In addition, we hypothesized that contrast induced endothelial dysfunction via free radicals. Thus, we also test alpha-lipoic acid whether or not protect endothelial dysfunction induced by contrast agents.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| contrast group (Ioversol) | Experimental | Other: Contrast agentEach individual will be given 80 ml Ioversol via intravenous injection within 5 minutes |
| Placebo group | Placebo comparator | – |
| alpha-lipoic acid group | Other | Other: Contrast agentAlpha-lipoic acid 600 mg in 0.9% sodium chloride 250 ml was administrated 1 hour before contrast agents via venous. and only 0.9% sodium chloride 250 ml was administrated for other 2 groups. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy men
- 20 yr < = age < = 30 yr
- 20 < = body mass index < = 25
Key exclusion criteria (3 listed)
- age < 20 yr or > 30 yr
- dysfunction for liver, renal, and heart.
- other diseases such as diabetes, hypertension, thyroid disease
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 |
|---|---|---|
| Contrast agent | Other | alpha-lipoic acid group, contrast group (Ioversol) |
Primary outcome
The endothelial dysfunction and the protective role of alpha-lipoic acid
Time frame: 6 months
1 secondary outcome
The apoptosis of endothelial progenitor cell
Time frame: 6 months
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 13 Aug 2015.
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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 4 study testing Contrast agent in people with Contrast Agent and Endothelial Function, run by Xiang Guang-da at 1 site in China.
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 3 inclusion and 3 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 13 Aug 2015. 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 China. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The endothelial dysfunction and the protective role of alpha-lipoic acid (time frame: 6 months). 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 13 Aug 2015.