Preoperative Assessment of Aortic Valve Stenosis and Coronary Artery Disease

NCT ID: NCT00767013

Last Updated: 2013-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Brief Summary

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We sought to determine whether the dual-source computed tomography assessment of aortic valve stenosis and coronary artery disease is equivalent to or even better than conventional invasive coronary angiography and transthoracic echocardiography.

Detailed Description

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Until now invasive coronary angiography has established itself for the assessment of symptomatic aortic valve stenosis. Literature shows a good correlation between MSCT, MRI, TTE and TEE for evaluating the severity of the aortic valve stenosis.

The dual-source computed tomography (DSCT) is capable of assessing coronary arteries with a high sensitivity and specificity in term of relevant stenosis (\>50%), due to its excellent spatial and temporal resolution. This study includes the assessment of patients with symptomatic valve stenosis. The severity of the aortic valve stenosis is being assessed by DSCT and TTE. Significant coronary artery stenosis and its localisation are assessed by DSCT and invasive coronary angiography. We examine the correlation between DSCT on one side and either TTE or invasive coronary angiography on the other.

Conditions

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Aortic Valve Stenosis Coronary Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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AVS, CAD

DSCT

Group Type EXPERIMENTAL

DSCT, TTE

Intervention Type OTHER

One assessment each

Interventions

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DSCT, TTE

One assessment each

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with aortic valve disease who were scheduled to undergo cardiac surgery

Exclusion Criteria

* Hemodynamic instability
* Renal insufficiency (serum creatinine level \> 133umol/L)
* Known allergy to iodinated contrast agents
* Non-treated hyperthyreosis
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Luzerner Kantonsspital

OTHER

Sponsor Role lead

Responsible Party

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Prof. Paul Erne

Prof. Paul Erne

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paul Erne, MD

Role: PRINCIPAL_INVESTIGATOR

Luzerner Kantonsspital

Locations

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Luzerner Kantonsspital, Department of Cardiology

Lucerne, Canton of Lucerne, Switzerland

Site Status RECRUITING

Countries

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Switzerland

Facility Contacts

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Paul Erne, MD

Role: primary

++41 41 205 51 06

Christoph Auf der Maur, MD

Role: backup

++41 41 2005 51 48

Other Identifiers

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Cardiac imaging DSCT

Identifier Type: -

Identifier Source: org_study_id

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