Preoperative Assessment of Aortic Valve Stenosis and Coronary Artery Disease

Coronary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00767013
• Other study ID #: Cardiac imaging DSCT
• Status: Recruiting
• Phase: N/A
• First received: October 3, 2008
• Last updated: April 16, 2013
• Start date: May 2007

Study information

• Verified date: April 2013
• Source: Luzerner Kantonsspital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Other:
• DSCT, TTE
One assessment each

Locations

Country	Name	City	State
Switzerland	Luzerner Kantonsspital, Department of Cardiology	Lucerne	Luzern

Sponsors (1)

Lead Sponsor	Collaborator
Luzerner Kantonsspital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of cardiac imaging in computed tomography		After comparison of imaging measurements	No