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Preoperative Assessment of Aortic Valve Stenosis and Coronary Artery Disease

Primary Purpose

Aortic Valve Stenosis, Coronary Disease

Status

Unknown status

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

DSCT, TTE

About this trial

This is an interventional diagnostic trial for Aortic Valve Stenosis focused on measuring DSCT, coronary artery disease, aortic valve stenosis

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Luzerner Kantonsspital, Department of CardiologyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AVS, CAD

Arm Description

DSCT

Outcomes

Primary Outcome Measures

Quality of cardiac imaging in computed tomography

Secondary Outcome Measures

Full Information

NCT ID

NCT00767013

First Posted

October 3, 2008

Last Updated

April 16, 2013

Sponsor

Luzerner Kantonsspital

1. Study Identification

Unique Protocol Identification Number

NCT00767013

Brief Title

Preoperative Assessment of Aortic Valve Stenosis and Coronary Artery Disease

Official Title

Preoperative Assessment of Aortic Valve Stenosis and Coronary Artery Disease: Dual-source Computed Tomography Compared With Invasive Coronary Angiography and Transthoracic Echocardiography

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Unknown status

Study Start Date

May 2007 (undefined)

Primary Completion Date

December 2013 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Luzerner Kantonsspital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aortic Valve Stenosis, Coronary Disease

Keywords

DSCT, coronary artery disease, aortic valve stenosis

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

65 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

AVS, CAD

Arm Type

Experimental

Arm Description

DSCT

Intervention Type

Other

Intervention Name(s)

DSCT, TTE

Intervention Description

One assessment each

Primary Outcome Measure Information:

Title

Quality of cardiac imaging in computed tomography

Time Frame

After comparison of imaging measurements

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul Erne, MD

Organizational Affiliation

Luzerner Kantonsspital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Luzerner Kantonsspital, Department of Cardiology

City

Lucerne

State/Province

Luzern

ZIP/Postal Code

6000

Country

Switzerland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Paul Erne, MD

Phone

++41 41 205 51 06

paul.erne@ksl.ch

First Name & Middle Initial & Last Name & Degree

Christoph Auf der Maur, MD

Phone

++41 41 2005 51 48

First Name & Middle Initial & Last Name & Degree

Paul Erne, MD

First Name & Middle Initial & Last Name & Degree

Christoph Auf der Maur, MD

12. IPD Sharing Statement

Learn more about this trial

Preoperative Assessment of Aortic Valve Stenosis and Coronary Artery Disease

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