Accuracy of the 64 Slices Computed Tomography for the Diagnosis of Left Atrial Appendage Thrombus (THROMBI-SCAN)

This study has been terminated.
(defect of inclusion)
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01147796
First received: June 18, 2010
Last updated: April 7, 2014
Last verified: September 2013

June 18, 2010
April 7, 2014
July 2010
July 2012   (final data collection date for primary outcome measure)
diagnosis LAA thrombus [ Time Frame: 24 h ] [ Designated as safety issue: No ]
evaluate the accuracy of the 64 slices CT using prospective gating for the diagnosis LAA thrombus
Same as current
Complete list of historical versions of study NCT01147796 on ClinicalTrials.gov Archive Site
optimal acquisition time [ Time Frame: 24H ] [ Designated as safety issue: No ]
the optimal acquisition time offering the best diagnostic performance
Same as current
Not Provided
Not Provided
 
Accuracy of the 64 Slices Computed Tomography for the Diagnosis of Left Atrial Appendage Thrombus
Accuracy of the 64 Slices Computed Tomography for the Diagnosis of Left Atrial Appendage Thrombus

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).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Thrombus
Device: computed tomography
64 slices CT with iodine injection
Other Name: computed tomography
  • Active Comparator: Thrombus
    patients with positive TEE (thrombus)
    Intervention: Device: computed tomography
  • Placebo Comparator: No thrombus
    patients with negative TEE (no thrombus)
    Intervention: Device: computed tomography
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
52
October 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01147796
P080607
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Jean Michel : Serfaty Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP