Thrombus Clinical Trial
— THROMBI-SCANOfficial title:
Accuracy of the 64 Slices Computed Tomography for the Diagnosis of Left Atrial Appendage Thrombus
Verified date | September 2013 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | France: Ministry of Health |
Study type | Interventional |
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).
Status | Terminated |
Enrollment | 52 |
Est. completion date | October 2012 |
Est. primary completion date | July 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
France | Bichat | Paris 18 |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | diagnosis LAA thrombus | evaluate the accuracy of the 64 slices CT using prospective gating for the diagnosis LAA thrombus | 24 h | No |
Secondary | optimal acquisition time | the optimal acquisition time offering the best diagnostic performance | 24H | No |
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