NCT01147796

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 22, 2010

Completed
9 days until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

March 10, 2015

Status Verified

September 1, 2013

Enrollment Period

2 years

First QC Date

June 18, 2010

Last Update Submit

March 6, 2015

Conditions

Thrombus

Keywords

Thrombuscomputed tomographyTransoesophageal echocardiography

Outcome Measures

Primary Outcomes (1)

  • diagnosis LAA thrombus

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

    24 h

Secondary Outcomes (1)

  • optimal acquisition time

    24H

Study Arms (2)

Thrombus

ACTIVE COMPARATOR

patients with positive TEE (thrombus)

Device: computed tomography

No thrombus

PLACEBO COMPARATOR

patients with negative TEE (no thrombus)

Device: computed tomography

Interventions

computed tomographyDEVICE

64 slices CT with iodine injection

Thrombus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients hospitalized at BICHAT hospital and referred for a TEE clinically motivated by search of a LAA thrombus
  • years old
  • signed informed consent 3 hours after TEE,
  • Have health insurance.

You may not qualify if:

  • woman into old of procreates
  • impaired renal function
  • Renal Hypoperfusion
  • drugs nephrotoxic
  • myeloma
  • over-sensitiveness with a product of iodized contrast
  • Contra-indication for CT with iodine injection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bichat

Paris, 75018, France

Location

MeSH Terms

Conditions

Thrombosis

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayTomography

Study Officials

  • Jean Michel : Serfaty

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2010

First Posted

June 22, 2010

Study Start

July 1, 2010

Primary Completion

July 1, 2012

Study Completion

October 1, 2012

Last Updated

March 10, 2015

Record last verified: 2013-09

Locations

FR(1)