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

Primary Purpose

Thrombus

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
computed tomography
computed tomography
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Thrombus focused on measuring Thrombus, computed tomography, Transoesophageal echocardiography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bichat

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Thrombus

No thrombus

Arm Description

patients with positive TEE (thrombus)

patients with negative TEE (no thrombus)

Outcomes

Primary Outcome Measures

diagnosis LAA thrombus
evaluate the accuracy of the 64 slices CT using prospective gating for the diagnosis LAA thrombus

Secondary Outcome Measures

optimal acquisition time
the optimal acquisition time offering the best diagnostic performance

Full Information

First Posted
June 18, 2010
Last Updated
March 6, 2015
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT01147796
Brief Title
Accuracy of the 64 Slices Computed Tomography for the Diagnosis of Left Atrial Appendage Thrombus
Acronym
THROMBI-SCAN
Official Title
Accuracy of the 64 Slices Computed Tomography for the Diagnosis of Left Atrial Appendage Thrombus
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Terminated
Why Stopped
defect of inclusion
Study Start Date
July 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombus
Keywords
Thrombus, computed tomography, Transoesophageal echocardiography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Thrombus
Arm Type
Active Comparator
Arm Description
patients with positive TEE (thrombus)
Arm Title
No thrombus
Arm Type
Placebo Comparator
Arm Description
patients with negative TEE (no thrombus)
Intervention Type
Device
Intervention Name(s)
computed tomography
Intervention Description
64 slices CT with iodine injection
Intervention Type
Device
Intervention Name(s)
computed tomography
Intervention Description
64 slices CT with iodine injection
Primary Outcome Measure Information:
Title
diagnosis LAA thrombus
Description
evaluate the accuracy of the 64 slices CT using prospective gating for the diagnosis LAA thrombus
Time Frame
24 h
Secondary Outcome Measure Information:
Title
optimal acquisition time
Description
the optimal acquisition time offering the best diagnostic performance
Time Frame
24H

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Michel : Serfaty
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bichat
City
Paris 18
ZIP/Postal Code
75018
Country
France

12. IPD Sharing Statement

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Accuracy of the 64 Slices Computed Tomography for the Diagnosis of Left Atrial Appendage Thrombus

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