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Preoperative Assessment of Aortic Valve Stenosis and Coronary Artery Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00767013
Recruitment Status : Unknown
Verified April 2013 by Prof. Paul Erne, Luzerner Kantonsspital.
Recruitment status was:  Recruiting
First Posted : October 6, 2008
Last Update Posted : April 17, 2013
Information provided by (Responsible Party):
Prof. Paul Erne, Luzerner Kantonsspital

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.

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Coronary Disease Other: DSCT, TTE Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : May 2007
Estimated Primary Completion Date : December 2013

Arm Intervention/treatment
Experimental: AVS, CAD
Other: DSCT, TTE
One assessment each

Primary Outcome Measures :
  1. Quality of cardiac imaging in computed tomography [ Time Frame: After comparison of imaging measurements ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00767013

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Luzerner Kantonsspital, Department of Cardiology Recruiting
Lucerne, Luzern, Switzerland, 6000
Contact: Paul Erne, MD    ++41 41 205 51 06   
Contact: Christoph Auf der Maur, MD    ++41 41 2005 51 48      
Principal Investigator: Paul Erne, MD         
Sub-Investigator: Christoph Auf der Maur, MD         
Sponsors and Collaborators
Luzerner Kantonsspital
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Principal Investigator: Paul Erne, MD Luzerner Kantonsspital

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Responsible Party: Prof. Paul Erne, Luzerner Kantonsspital Identifier: NCT00767013    
Other Study ID Numbers: Cardiac imaging DSCT
First Posted: October 6, 2008    Key Record Dates
Last Update Posted: April 17, 2013
Last Verified: April 2013
Keywords provided by Prof. Paul Erne, Luzerner Kantonsspital:
DSCT, coronary artery disease, aortic valve stenosis
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Aortic Valve Stenosis
Constriction, Pathologic
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Pathological Conditions, Anatomical
Heart Valve Diseases
Ventricular Outflow Obstruction