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
  Purpose

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 Intervention
Thrombus
Device: computed tomography

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Accuracy of the 64 Slices Computed Tomography for the Diagnosis of Left Atrial Appendage Thrombus

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • optimal acquisition time [ Time Frame: 24H ] [ Designated as safety issue: No ]
    the optimal acquisition time offering the best diagnostic performance


Enrollment: 52
Study Start Date: July 2010
Study Completion Date: October 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Thrombus
patients with positive TEE (thrombus)
Device: computed tomography
64 slices CT with iodine injection
Other Name: computed tomography
Placebo Comparator: No thrombus
patients with negative TEE (no thrombus)
Device: computed tomography
64 slices CT with iodine injection
Other Name: computed tomography

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01147796

Locations
France
Bichat
Paris 18, France, 75018
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Jean Michel : Serfaty Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01147796     History of Changes
Other Study ID Numbers: P080607
Study First Received: June 18, 2010
Last Updated: April 7, 2014
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Thrombus
computed tomography
Transoesophageal echocardiography

ClinicalTrials.gov processed this record on September 16, 2014