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

NCT ID: NCT01147796

Last Updated: 2015-03-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2012-10-31

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.

Conditions

Thrombus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Thrombus

patients with positive TEE (thrombus)

Group Type: ACTIVE_COMPARATOR

computed tomography

Intervention Type: DEVICE

64 slices CT with iodine injection

No thrombus

patients with negative TEE (no thrombus)

Group Type: PLACEBO_COMPARATOR

computed tomography

Intervention Type: DEVICE

64 slices CT with iodine injection

Interventions

computed tomography

64 slices CT with iodine injection

Intervention Type: DEVICE

computed tomography

64 slices CT with iodine injection

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean Michel : Serfaty

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Bichat

Paris, , France

Countries

France

Other Identifiers

P080607

Identifier Type: -

Identifier Source: org_study_id