NCT00767013

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 6, 2008

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Last Updated

April 17, 2013

Status Verified

April 1, 2013

Enrollment Period

6.6 years

First QC Date

October 3, 2008

Last Update Submit

April 16, 2013

Conditions

Aortic Valve StenosisCoronary Disease

Keywords

DSCT, coronary artery disease, aortic valve stenosis

Outcome Measures

Primary Outcomes (1)

  • Quality of cardiac imaging in computed tomography

    After comparison of imaging measurements

Study Arms (1)

AVS, CAD

EXPERIMENTAL

DSCT

Other: DSCT, TTE

Interventions

DSCT, TTEOTHER

One assessment each

AVS, CAD

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with aortic valve disease who were scheduled to undergo cardiac surgery

You may not qualify if:

  • Hemodynamic instability
  • Renal insufficiency (serum creatinine level \> 133umol/L)
  • Known allergy to iodinated contrast agents
  • Non-treated hyperthyreosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Luzerner Kantonsspital, Department of Cardiology

Lucerne, Canton of Lucerne, 6000, Switzerland

RECRUITING

MeSH Terms

Conditions

Aortic Valve StenosisCoronary DiseaseCoronary Artery Disease

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow ObstructionMyocardial IschemiaVascular DiseasesArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Paul Erne, MD

    Luzerner Kantonsspital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Paul Erne

Study Record Dates

First Submitted

October 3, 2008

First Posted

October 6, 2008

Study Start

May 1, 2007

Primary Completion

December 1, 2013

Last Updated

April 17, 2013

Record last verified: 2013-04

Locations

CH(1)