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Preoperative Assessment of Aortic Valve Stenosis and Coronary Artery Disease

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2013 by Prof. Paul Erne, Luzerner Kantonsspital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00767013
First Posted: October 6, 2008
Last Update Posted: April 17, 2013
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.
Information provided by (Responsible Party):
Prof. Paul Erne, Luzerner Kantonsspital
  Purpose
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 Intervention
Aortic Valve Stenosis Coronary Disease Other: DSCT, TTE

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Prof. Paul Erne, Luzerner Kantonsspital:

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

Estimated Enrollment: 65
Study Start Date: May 2007
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AVS, CAD
DSCT
Other: DSCT, TTE
One assessment each

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00767013


Locations
Switzerland
Luzerner Kantonsspital, Department of Cardiology Recruiting
Lucerne, Luzern, Switzerland, 6000
Contact: Paul Erne, MD    ++41 41 205 51 06    paul.erne@ksl.ch   
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
Investigators
Principal Investigator: Paul Erne, MD Luzerner Kantonsspital
  More Information

Responsible Party: Prof. Paul Erne, Luzerner Kantonsspital
ClinicalTrials.gov Identifier: NCT00767013     History of Changes
Other Study ID Numbers: Cardiac imaging DSCT
First Submitted: October 3, 2008
First Posted: October 6, 2008
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:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Constriction, Pathologic
Aortic Valve Stenosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathological Conditions, Anatomical
Heart Valve Diseases
Ventricular Outflow Obstruction