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

• Sponsor: Assistance Publique - Hôpitaux de Paris (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01147796
• Collaborator: (none)
• Enrollment: 52
• Location: 1
• Arms: 2
• Duration (Months): 27
• Patients Per Site Per Month: 1.9

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Thrombus	Device: computed tomography; Device: computed tomography	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Accuracy of the 64 Slices Computed Tomography for the Diagnosis of Left Atrial Appendage Thrombus
• Study Start Date: Jul 1, 2010
• Actual Primary Completion Date: Jul 1, 2012
• Actual Study Completion Date: Oct 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. diagnosis LAA thrombus [24 h]

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

Secondary Outcome Measures

1. optimal acquisition time [24H]

   the optimal acquisition time offering the best diagnostic performance

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bichat	Paris 18		France	75018

Sponsors and Collaborators

• Assistance Publique - Hôpitaux de Paris

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT01147796
• Other Study ID Numbers: P080607
• First Posted: Jun 22, 2010
• Last Update Posted: Mar 10, 2015
• Last Verified: Sep 1, 2013

• Keywords provided by Assistance Publique - Hôpitaux de Paris: Thrombus; computed tomography; Transoesophageal echocardiography
• Additional relevant MeSH terms: Thrombosis

Study Results

No Results Posted as of Mar 10, 2015