- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00767013
Preoperative Assessment of Aortic Valve Stenosis and Coronary Artery Disease
Preoperative Assessment of Aortic Valve Stenosis and Coronary Artery Disease: Dual-source Computed Tomography Compared With Invasive Coronary Angiography and Transthoracic Echocardiography
Study Overview
Status
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Luzern
-
Lucerne, Luzern, Switzerland, 6000
- Recruiting
- Luzerner Kantonsspital, Department of Cardiology
-
Contact:
- Paul Erne, MD
- Phone Number: ++41 41 205 51 06
- Email: paul.erne@ksl.ch
-
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
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
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Pathological Conditions, Anatomical
- Aortic Valve Disease
- Heart Valve Diseases
- Ventricular Outflow Obstruction
- Coronary Artery Disease
- Myocardial Ischemia
- Coronary Disease
- Aortic Valve Stenosis
- Constriction, Pathologic
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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