Preoperative Assessment of Aortic Valve Stenosis and Coronary Artery Disease - Full Text View

Sponsored by:	Kantonsspital Luzern
Information provided by:	Kantonsspital Luzern
ClinicalTrials.gov Identifier:	NCT00767013

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

MedlinePlus related topics: CT Scans Coronary Artery Disease

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Single Group Assignment
Official Title:	Preoperative Assessment of Aortic Valve Stenosis and Coronary Artery Disease: Dual-Source Computed Tomography Compared With Invasive Coronary Angiography and Transthoracic Echocardiography

Further study details as provided by Kantonsspital Luzern:

Primary Outcome Measures:

Quality of cardiac imaging in computed tomography [ Time Frame: After comparison of imaging measurements ] [ Designated as safety issue: No ]

Estimated Enrollment:	65
Study Start Date:	May 2007

Arms	Assigned Interventions
AVS, CAD: Experimental 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

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00767013

Locations

Switzerland, Luzern
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

Kantonsspital Luzern

Investigators

Principal Investigator:

Paul Erne, MD

Luzerner Kantonsspital

More Information

Responsible Party:	Luzerner Kantonsspital ( Paul Erne )
Study ID Numbers:	Cardiac imaging DSCT
Study First Received:	October 3, 2008
Last Updated:	October 3, 2008
ClinicalTrials.gov Identifier:	NCT00767013
Health Authority:	Switzerland: Ethikkommission

Keywords provided by Kantonsspital Luzern:

DSCT, coronary artery disease, aortic valve stenosis

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Arterial Occlusive Diseases
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Constriction, Pathologic
Ischemia

Arteriosclerosis
Aortic valve stenosis
Heart Valve Diseases
Coronary Disease
Aortic Valve Stenosis
Coronary Artery Disease

Additional relevant MeSH terms:

Cardiovascular Diseases
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on January 16, 2009