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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.
 
ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
Prof. Paul Erne, Luzerner Kantonsspital

Tracking Information
First Submitted Date  ICMJE October 3, 2008
First Posted Date  ICMJE October 6, 2008
Last Update Posted Date April 17, 2013
Study Start Date  ICMJE May 2007
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 3, 2008)
Quality of cardiac imaging in computed tomography [ Time Frame: After comparison of imaging measurements ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preoperative Assessment of Aortic Valve Stenosis and Coronary Artery Disease
Official Title  ICMJE Preoperative Assessment of Aortic Valve Stenosis and Coronary Artery Disease: Dual-source Computed Tomography Compared With Invasive Coronary Angiography and Transthoracic Echocardiography
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Aortic Valve Stenosis
  • Coronary Disease
Intervention  ICMJE Other: DSCT, TTE
One assessment each
Study Arms  ICMJE Experimental: AVS, CAD
DSCT
Intervention: Other: DSCT, TTE
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 3, 2008)
65
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00767013
Other Study ID Numbers  ICMJE Cardiac imaging DSCT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Paul Erne, Luzerner Kantonsspital
Study Sponsor  ICMJE Luzerner Kantonsspital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Paul Erne, MD Luzerner Kantonsspital
PRS Account Luzerner Kantonsspital
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP