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

March 6, 2015 updated by: Assistance Publique - Hôpitaux de Paris
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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris 18, France, 75018
        • BICHAT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Thrombus
patients with positive TEE (thrombus)
Device: computed tomography
64 slices CT with iodine injection
Placebo Comparator: No thrombus
patients with negative TEE (no thrombus)
Device: computed tomography
64 slices CT with iodine injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
diagnosis LAA thrombus
Time Frame: 24 h
evaluate the accuracy of the 64 slices CT using prospective gating for the diagnosis LAA thrombus
24 h

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
optimal acquisition time
Time Frame: 24H
the optimal acquisition time offering the best diagnostic performance
24H

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Jean Michel : Serfaty, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

June 18, 2010

First Submitted That Met QC Criteria

June 18, 2010

First Posted (Estimate)

June 22, 2010

Study Record Updates

Last Update Posted (Estimate)

March 10, 2015

Last Update Submitted That Met QC Criteria

March 6, 2015

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P080607

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe