Infective Endocarditiscardiac CTNCT00550823
Cardiac Computarized Tomography in Infective Endocarditis
A study testing Cardiac CT 0BRILLIANT 64 in people with Infective Endocarditis, run by Tel-Aviv Sourasky Medical Center.
Trial summary
The diagnosis of infective endocarditis is based on the results of blood culture and findings on transeosophageal echocardiography. Cardiac computarized tomography is a new modality, mainly used for the imaging of coronary arteries. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Infective Endocarditis
- What is being tested?
- Cardiac CT 0BRILLIANT 64
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to Nov 2008
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with infective endocarditis
Who cannot join
- Allergy to contrast agent
About this study
Official title: The Use of Cardiac Computarized Tomography in Infective Endocarditis
The diagnosis of infective endocarditis is based on the results of blood culture and findings on transeosophageal echocardiography. Cardiac computarized tomography is a new modality, mainly used for the imaging of coronary arteries. Its use in the diagnosis of infective endocarditis is not well known.The purpose of this study is to establish the use of cardiac CT in infective endocarditis.
- Conditions
- Infective Endocarditis
- Being tested
- Cardiac CT 0BRILLIANT 64
- Medical subject headings
- Endocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac CT 0BRILLIANT 64Device
Cardiac CT
| Study group | Role | What they receive |
|---|---|---|
| A,1 | Experimental | Not described Receives: Device: Cardiac CT 0BRILLIANT 64 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The diagnostic capacity of cardiac CT in comparison with TEE in the diagnosis of infective endocarditis
Measured: 1 year
Secondary outcomes (1)
Assessment of cardiac function in patients with infective endocarditis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2007 (estimated)
- Study startNov 2007
- Study completionNov 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infective EndocarditisStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Investigators
- Ori Elkayam, M.D, Principal investigator, Tel Aviv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00550823
- Sponsor's protocol ID
- 362-07
- Acronym
- cardiac CT
- Status last verified
- Oct 2007
- First submitted
- 27 Oct 2007
- Last updated
- 30 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Cardiac Computarized Tomography in Infective Endocarditis
- ClinicalTrials.gov ID
- NCT00550823
- Acronym / sponsor ID
- cardiac CT / 362-07
- Conditions
- Infective Endocarditis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Nov 2007
- Study completion
- Nov 2008 (estimated)
- First posted
- 30 Oct 2007 (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 diagnosis of infective endocarditis is based on the results of blood culture and findings on transeosophageal echocardiography. Cardiac computarized tomography is a new modality, mainly used for the imaging of coronary arteries. Its use in the diagnosis of infective endocarditis is not well known.The purpose of this study is to establish the use of cardiac CT in infective endocarditis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A,1 | Experimental | Device: Cardiac CT 0BRILLIANT 64 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with infective endocarditis
Key exclusion criteria (1 listed)
- Allergy to contrast agent
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 |
|---|---|---|
| Cardiac CT 0BRILLIANT 64Cardiac CT | Device | A,1 |
Primary outcome
The diagnostic capacity of cardiac CT in comparison with TEE in the diagnosis of infective endocarditis
Time frame: 1 year
1 secondary outcome
Assessment of cardiac function in patients with infective endocarditis
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2007.
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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.
Ori Elkayam, M.D principal investigator
Tel Aviv Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac CT 0BRILLIANT 64 in people with Infective Endocarditis, run by Tel-Aviv Sourasky Medical Center.
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 1 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: status not confirmed, as of the sponsor's last update on 30 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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 diagnostic capacity of cardiac CT in comparison with TEE in the diagnosis of infective endocarditis (time frame: 1 year). 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 30 Oct 2007.