Preoperative Assessment of Aortic Valve Stenosis and Coronary Artery Disease

April 16, 2013 updated by: Prof. Paul Erne, Luzerner Kantonsspital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Luzern
      • Lucerne, Luzern, Switzerland, 6000
        • Recruiting
        • Luzerner Kantonsspital, Department of Cardiology
        • Contact:
        • Contact:
          • Christoph Auf der Maur, MD
          • Phone Number: ++41 41 2005 51 48
        • Principal Investigator:
          • Paul Erne, MD
        • Sub-Investigator:
          • Christoph Auf der Maur, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: AVS, CAD
DSCT
Other: DSCT, TTE
One assessment each

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quality of cardiac imaging in computed tomography
Time Frame: After comparison of imaging measurements
After comparison of imaging measurements

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Luzerner Kantonsspital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (ANTICIPATED)

December 1, 2013

Study Registration Dates

First Submitted

October 3, 2008

First Submitted That Met QC Criteria

October 3, 2008

First Posted (ESTIMATE)

October 6, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

April 17, 2013

Last Update Submitted That Met QC Criteria

April 16, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cardiac imaging DSCT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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