ThrombusTHROMBI-SCANNCT01147796
Accuracy of the 64 Slices Computed Tomography for the Diagnosis of Left Atrial Appendage Thrombus
A study testing computed tomography in people with Thrombus, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Transoesophageal echocardiography (TEE) is considered as the gold standard method for detection of left atrial appendage (LAA) thrombus but is a semi-invasive investigation. The primary aim of the study is to evaluate the accuracy of the 64 slices CT using prospective gating for the diagnosis LAA thrombus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombus
- What is being tested?
- computed tomography
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2010to Oct 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients hospitalized at BICHAT hospital and referred for a TEE clinically motivated by search of a LAA thrombus
- 18 years old
- signed informed consent 3 hours after TEE,
- Have health insurance.
Who cannot join
- woman into old of procreates
- impaired renal function
- Renal Hypoperfusion
- drugs nephrotoxic
- myeloma
- iodine injection 48 h before the inclusion
- over-sensitiveness with a product of iodized contrast
- Contra-indication for CT with iodine injection
Trial locations and contacts
1 site in 1 country.
About this study
Transoesophageal echocardiography (TEE) is considered as the gold standard method for detection of left atrial appendage (LAA) thrombus but is a semi-invasive investigation. The primary aim of the study is to evaluate the accuracy of the 64 slices CT using prospective gating for the diagnosis LAA thrombus. The secondary objective is to defined the optimal acquisition time offering the best diagnostic performance (early, late or both).
Read the detailed description
Left atrial appendage (LAA) thrombus is a major cause of cardiogenic embolism. It is responsible of high morbidity and mortality and translates into significant modifications of patient management. Transoesophageal echocardiography (TEE) is considered as the gold standard method for detection of LAA thrombus but is a semi-invasive investigation. TEE is indeed performed using intravenous benzodiazepines sedation in order to optimize patient tolerance and quality for the operator or even under general anesthesia. To date there is no other validated method for the assessment of LAA thrombus. Multidetector computed tomography (CT) is currently widely used the assessment of cardiac function and geometry as well as coronary artery anatomy. Technologic improvement with the 64 slices CT, offering a high temporal and spatial resolution, and the new prospective gating, reducing drastically the irradiation dose, make it particularly attractive for the assessment of LAA thrombus but it has never been evaluated is this indication. Furthermore, the addition to the current arterial or "early" acquisition time, a second "late" acquisition (2 minutes later) may reduce false positive results.
Aims of the study. The primary aim of the study is to evaluate the accuracy of the 64 slices CT using prospective gating for the diagnosis LAA thrombus. The secondary objective is to defined the optimal acquisition time offering the best diagnostic performance (early, late or both).
Design of the study. The present study is a preliminary MONOCENTER study in which TEE is the reference method and the 64 slices CT with iodine injection and prospective gating the method to assess. All patients hospitalized at BICHAT hospital and referred for a TEE clinically motivated by search of a LAA thrombus are potential candidates for the present study. To insure the feasibility of the study with a rigorous methodology TEE will be performed in all patients but the prevalence of LAA thrombus will be deliberately increased and patients with negative TEE (no thrombus) to whom the CT will be performed will be randomized. Both TEE and CT will be performed within 18 hours. All CT analysis will be centralized and performed blinded of any clinical of echocardiographic information at the end of the inclusion period of the study. We planned to enroll 135 patients under a two years period.
Clinical implications. Validation of the 64 slices computed tomography with prospective gating may reduce TEE indications and improve patients' comfort.
- Conditions
- Thrombus
- Being tested
- computed tomography
- Keywords
- Thrombus, computed tomography, Transoesophageal echocardiography
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computed tomographyDevice
64 slices CT with iodine injection
computed tomographyDevice
64 slices CT with iodine injection
| Study group | Role | What they receive |
|---|---|---|
| Thrombus | Active comparator | patients with positive TEE (thrombus) Receives: Device: computed tomography |
| No thrombus | Placebo comparator | patients with negative TEE (no thrombus) Receives: Device: computed tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnosis LAA thrombus
evaluate the accuracy of the 64 slices CT using prospective gating for the diagnosis LAA thrombus
Measured: 24 h
Secondary outcomes (1)
optimal acquisition time
the optimal acquisition time offering the best diagnostic performance
Measured: 24H
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2012
- Study completionOct 2012
Why it stopped: defect of inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombusStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Michel : Serfaty, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01147796
- Sponsor's protocol ID
- P080607
- Acronym
- THROMBI-SCAN
- Status last verified
- Sep 2013
- First submitted
- 18 Jun 2010
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of the 64 Slices Computed Tomography for the Diagnosis of Left Atrial Appendage Thrombus
- ClinicalTrials.gov ID
- NCT01147796
- Acronym / sponsor ID
- THROMBI-SCAN / P080607
- Conditions
- Thrombus
- Keywords
- Thrombus, computed tomography, Transoesophageal echocardiography
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: defect of inclusion
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 22 Jun 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.
Transoesophageal echocardiography (TEE) is considered as the gold standard method for detection of left atrial appendage (LAA) thrombus but is a semi-invasive investigation. The primary aim of the study is to evaluate the accuracy of the 64 slices CT using prospective gating for the diagnosis LAA thrombus. The secondary objective is to defined the optimal acquisition time offering the best diagnostic performance (early, late or both).
Detailed description
Left atrial appendage (LAA) thrombus is a major cause of cardiogenic embolism. It is responsible of high morbidity and mortality and translates into significant modifications of patient management. Transoesophageal echocardiography (TEE) is considered as the gold standard method for detection of LAA thrombus but is a semi-invasive investigation. TEE is indeed performed using intravenous benzodiazepines sedation in order to optimize patient tolerance and quality for the operator or even under general anesthesia. To date there is no other validated method for the assessment of LAA thrombus. Multidetector computed tomography (CT) is currently widely used the assessment of cardiac function and geometry as well as coronary artery anatomy. Technologic improvement with the 64 slices CT, offering a high temporal and spatial resolution, and the new prospective gating, reducing drastically the irradiation dose, make it particularly attractive for the assessment of LAA thrombus but it has never been evaluated is this indication. Furthermore, the addition to the current arterial or "early" acquisition time, a second "late" acquisition (2 minutes later) may reduce false positive results.
Aims of the study. The primary aim of the study is to evaluate the accuracy of the 64 slices CT using prospective gating for the diagnosis LAA thrombus. The secondary objective is to defined the optimal acquisition time offering the best diagnostic performance (early, late or both).
Design of the study. The present study is a preliminary MONOCENTER study in which TEE is the reference method and the 64 slices CT with iodine injection and prospective gating the method to assess. All patients hospitalized at BICHAT hospital and referred for a TEE clinically motivated by search of a LAA thrombus are potential candidates for the present study. To insure the feasibility of the study with a rigorous methodology TEE will be performed in all patients but the prevalence of LAA thrombus will be deliberately increased and patients with negative TEE (no thrombus) to whom the CT will be performed will be randomized. Both TEE and CT will be performed within 18 hours. All CT analysis will be centralized and performed blinded of any clinical of echocardiographic information at the end of the inclusion period of the study. We planned to enroll 135 patients under a two years period.
Clinical implications. Validation of the 64 slices computed tomography with prospective gating may reduce TEE indications and improve patients' comfort.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thrombus | Active comparator | Device: computed tomographypatients with positive TEE (thrombus) |
| No thrombus | Placebo comparator | Device: computed tomographypatients with negative TEE (no thrombus) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All patients hospitalized at BICHAT hospital and referred for a TEE clinically motivated by search of a LAA thrombus
- 18 years old
- signed informed consent 3 hours after TEE,
- Have health insurance.
Key exclusion criteria (8 listed)
- woman into old of procreates
- impaired renal function
- Renal Hypoperfusion
- drugs nephrotoxic
- myeloma
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 |
|---|---|---|
| computed tomography64 slices CT with iodine injection | Device | Thrombus |
| computed tomography64 slices CT with iodine injection | Device | No thrombus |
Primary outcome
diagnosis LAA thrombus
Time frame: 24 h
evaluate the accuracy of the 64 slices CT using prospective gating for the diagnosis LAA thrombus
1 secondary outcome
optimal acquisition time
Time frame: 24H
Results and safety
The study was stopped early (reason given: defect of inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 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.
Jean Michel : Serfaty principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing computed tomography in people with Thrombus, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 8 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 10 Mar 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 France. 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.
Are results available for this study?
The study was stopped early (reason given: defect of inclusion). 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?
diagnosis LAA thrombus (time frame: 24 h). 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 10 Mar 2015.