AngiocardiographyTRUSTNCT01206257
The Safety and toleRability of UltraviSt in Patients Undergoing Cardiac CaTheterization (TRUST)
An observational study of Angiocardiography, run by Bayer at 1 site in China.
Trial summary
This study is to collect the information of Ultravist® in the patients indicated for the coronary angiography or PCI, like rate of ADR in patients, the dose for different indications, image quality to prove Ultravist the good safety and effectivity Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Angiocardiography
- What is being tested?
- Iopromide (Ultravist, BAY86-4877)
- Type of treatment
- Injection or infusion
- How many people
- 17,513 participants
- Where
- 1 siteChina
- Study dates
- Aug 2010to Sep 2011
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who plan to undergo coronary angiography or PCI procedure with ultravist will be enrolled
Who may be able to join
- Female and male patients who receive Ultravist® for coronary angiography or PCI can be included in the study
Who cannot join
- Patients who are or are suspected in pregnancy or nursery
- Patients with the contraindications for Ultravist
- Patients with the contraindications for cardiac catheterization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: This is an International, Prospective, Non-interventional Study, Company Sponsored, Multi-center Study. Patients Undergo Coronary Angiography or PCI Procedure With Ultravist. The Primary Objective is to Evaluate the Safety and Tolerability.
This study is to collect the information of Ultravist® in the patients indicated for the coronary angiography or PCI, like rate of ADR in patients, the dose for different indications, image quality to prove Ultravist the good safety and effectivity
- Conditions
- Angiocardiography
- Being tested
- Iopromide (Ultravist, BAY86-4877)
- Keywords
- Survey, Angiography, ADR, Image quality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iopromide (Ultravist, BAY86-4877)Drug
Intravenous/intraarterial digital subtraction angiography (DSA); Generally doses of up to 1.5 g iodine per kg body weight are well tolerated.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Iopromide (Ultravist, BAY86-4877) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the safety and tolerability of Ultravist® in patients Undergoing cardiac catheterization.
Measured: 12 months
Secondary outcomes (1)
Estimation of the image quality of Ultravist®
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2010 (estimated)
- Study startAug 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AngiocardiographyStudies of the same condition, open and under way.
- More trials run by BayerThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17,513 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01206257
- Sponsor's protocol ID
- 15454
- Other IDs
- UV1010CN
- Acronym
- TRUST
- Status last verified
- Jun 2013
- First submitted
- 20 Sep 2010
- Last updated
- 11 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- This is an International, Prospective, Non-interventional Study, Company Sponsored, Multi-center Study. Patients Undergo Coronary Angiography or PCI Procedure With Ultravist. The Primary Objective is to Evaluate the Safety and Tolerability.
- ClinicalTrials.gov ID
- NCT01206257
- Acronym / sponsor ID
- TRUST / 15454
- Conditions
- Angiocardiography
- Keywords
- Survey, Angiography, ADR, Image quality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17,513 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 21 Sep 2010 (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.
This study is to collect the information of Ultravist® in the patients indicated for the coronary angiography or PCI, like rate of ADR in patients, the dose for different indications, image quality to prove Ultravist the good safety and effectivity
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Iopromide (Ultravist, BAY86-4877) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who plan to undergo coronary angiography or PCI procedure with ultravist will be enrolled
Key inclusion criteria (1 listed)
- Female and male patients who receive Ultravist® for coronary angiography or PCI can be included in the study
Key exclusion criteria (3 listed)
- Patients who are or are suspected in pregnancy or nursery
- Patients with the contraindications for Ultravist
- Patients with the contraindications for cardiac catheterization
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 |
|---|---|---|
| Iopromide (Ultravist, BAY86-4877)Intravenous/intraarterial digital subtraction angiography (DSA); Generally doses of up to 1.5 g iodine per kg body weight are well tolerated. | Drug | Group 1 |
Primary outcome
Evaluation of the safety and tolerability of Ultravist® in patients Undergoing cardiac catheterization.
Time frame: 12 months
1 secondary outcome
Estimation of the image quality of Ultravist®
Time frame: 12 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 11 Jun 2013.
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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.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Angiocardiography, run by Bayer 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 1 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 11 Jun 2013. 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. 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?
Evaluation of the safety and tolerability of Ultravist® in patients Undergoing cardiac catheterization. (time frame: 12 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 11 Jun 2013.