EndocarditisNCT00995384
Cardiac Computed Tomography (CT) Scan Compared to Transesophageal Echocardiogram (TEE) in Endocarditis
A study testing CT Scan in people with Endocarditis, run by Corewell Health East at 1 site in United States.
Trial summary
The purpose of this study is to assess the effectiveness of cardiac CT versus TEE in endocarditis patients. Read more about this study
- Who is it for?
- Ages 18 to 98 years
- Conditions the study is for
- Endocarditis
- What is being tested?
- CT Scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Oct 2010
- 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 98 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute endocarditis with positive TEE
Who cannot join
- Renal failure
- Contrast dye allergy
- Beta-blocker allergy
Trial locations and contacts
1 site in 1 country.
United States1 site
William Beaumont Hosptial
Royal Oak, Michigan, 48073
About this study
Official title: A Novel Modality of Cardiac CT in Characterization of Acute Infective Endocarditis
The purpose of this study is to assess the effectiveness of cardiac CT versus TEE in endocarditis patients.
- Conditions
- Endocarditis
- Being tested
- CT Scan
- Medical subject headings
- Endocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT ScanProcedure or surgery
Cardiac CT with special attention to valves in Endocarditis patients.
| Study group | Role | What they receive |
|---|---|---|
| CT scan | Other | CT Scan for endocarditis patients. All patients receive intervention. Receives: Procedure: CT Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Difference in CT versus TEE images in Endocarditis
Measured: Upon CT Scan
Secondary outcomes (1)
Morbidity
Measured: 4 weeks & 6 months post CT scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionOct 2010
- Study completionOct 2010
Why it stopped: Difficult recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Phillip Kadaj, MD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00995384
- Sponsor's protocol ID
- HIC 2009-148
- Other IDs
- R/C# 98699, RI-09-17
- Status last verified
- Mar 2012
- First submitted
- 14 Oct 2009
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Modality of Cardiac CT in Characterization of Acute Infective Endocarditis
- ClinicalTrials.gov ID
- NCT00995384
- Acronym / sponsor ID
- HIC 2009-148
- Conditions
- Endocarditis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficult recruitment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 15 Oct 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 purpose of this study is to assess the effectiveness of cardiac CT versus TEE in endocarditis patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT scan | Other | Procedure: CT ScanCT Scan for endocarditis patients. All patients receive intervention. |
Who may qualify
- Ages
- 18 to 98 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Acute endocarditis with positive TEE
Key exclusion criteria (3 listed)
- Renal failure
- Contrast dye allergy
- Beta-blocker allergy
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 |
|---|---|---|
| CT ScanCardiac CT with special attention to valves in Endocarditis patients. | Procedure or surgery | CT scan |
Primary outcome
Visual Difference in CT versus TEE images in Endocarditis
Time frame: Upon CT Scan
1 secondary outcome
Morbidity
Time frame: 4 weeks & 6 months post CT scan
Results and safety
The study was stopped early (reason given: Difficult recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
Related trials for Endocarditis
Not yet recruiting
Metabolic Profiling Among Patients Suspected of Infective Endocarditis - PPSIE Comparing Metabolomes of Bloodstream Infections Versus Infective Endocarditis
Infective Endocarditis (IE)
Recruiting
CBCT vs OPT on the Oral Health Status at 12 Months of Patients Hospitalized for Infective Endocarditis.
Infective Endocarditis
RecruitingPhase 2
Combination Cefazolin With Ertapenem for Methicillin-susceptible Staphylococcus Aureus Bacteremia
Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Septicemia
RecruitingObservational study
Impact of Preoperative Dental Screening in Reducing Infective Endocarditis Risk in Transcatheter Aortic Valve Implantation Patients
Transcatheter Aortic Valve Implantation, Dental
Not yet recruitingObservational study
REVIVE-FR Registry
Bioprosthetic Valve Failure, Prosthetic Heart Valve Dysfunction
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.
Phillip Kadaj, MD principal investigator
Corewell Health East
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT Scan in people with Endocarditis, run by Corewell Health East 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 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: stopped early, as of the sponsor's last update on 28 Mar 2023. 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.
Are results available for this study?
The study was stopped early (reason given: Difficult recruitment). 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?
Visual Difference in CT versus TEE images in Endocarditis (time frame: Upon CT Scan). 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 28 Mar 2023.