Pulmonary EmbolismPhase 4NCT00351754
Detection of Pulmonary Embolism With CECT
A Phase 4 study testing Isovue in people with Pulmonary Embolism, run by Bracco Diagnostics, Inc at 1 site in United States.
Trial summary
To compare the vascular enhancement of the two contrast agents in pulmonary Multi-detector CTA Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Isovue
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Nov 2006
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 yrs or older
- With suspected PE
- Referred for MDCTA of pulmonary arteries
- Signed informed consent
Who cannot join
- Pregnant and lactating females
- History of hypersensitivity to iodinated contrast agents
- Hyperthyroidism or pheochromocytoma
- Severe CHF
- Renal impairment
- Weight greater than 300 lbs
Show all 10Show fewer
- Pacemaker
- Swan Ganz catheter
- Defibrillator or other intrathoracic metallic vascular device
- Received an investigational compound within 30 days of being in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Bracco Diagnostics, Inc.
Princeton, New Jersey, 08540
About this study
Official title: Detection of Pulmonary Embolism Comparing Isovue-370 and Visipaque 320 Using 64-Slice Multi-Detector Computed Tomographic Angiography
To compare the vascular enhancement of the two contrast agents in pulmonary Multi-detector CTA
- Conditions
- Pulmonary Embolism
- Being tested
- Isovue
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsovueDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Hounsfield Units (HU) measured at various levels of pulmonary arteries
Secondary outcomes (1)
Presence of artifacts; global enhancement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2006 (estimated)
- Study startJul 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- Bracco Diagnostics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Steve Sireci, M.D., Study director, Bracco Diagnostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00351754
- Sponsor's protocol ID
- IOP 106
- Status last verified
- Jan 2008
- First submitted
- 30 Jun 2006
- Last updated
- 7 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Pulmonary Embolism Comparing Isovue-370 and Visipaque 320 Using 64-Slice Multi-Detector Computed Tomographic Angiography
- ClinicalTrials.gov ID
- NCT00351754
- Acronym / sponsor ID
- IOP 106
- Conditions
- Pulmonary Embolism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- Bracco Diagnostics, IncIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Study completion
- Nov 2006 (actual)
- First posted
- 13 Jul 2006 (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.
To compare the vascular enhancement of the two contrast agents in pulmonary Multi-detector CTA
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients 18 yrs or older
- With suspected PE
- Referred for MDCTA of pulmonary arteries
- Signed informed consent
Key exclusion criteria (10 listed)
- Pregnant and lactating females
- History of hypersensitivity to iodinated contrast agents
- Hyperthyroidism or pheochromocytoma
- Severe CHF
- Renal impairment
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 |
|---|---|---|
| Isovue | Drug | – |
Primary outcome
Hounsfield Units (HU) measured at various levels of pulmonary arteries
1 secondary outcome
Presence of artifacts; global enhancement
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 7 Jan 2008.
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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.
Steve Sireci, M.D. study director
Bracco Diagnostics
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 Isovue in people with Pulmonary Embolism, run by Bracco Diagnostics, Inc 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 10 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 7 Jan 2008. 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 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?
Hounsfield Units (HU) measured at various levels of pulmonary arteries. 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 7 Jan 2008.