Aortic Valve StenosisNCT00767013
Preoperative Assessment of Aortic Valve Stenosis and Coronary Artery Disease
A study testing DSCT, TTE in people with Aortic Valve Stenosis and Coronary Disease, run by Luzerner Kantonsspital at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Coronary Disease
- What is being tested?
- DSCT, TTE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2007to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with aortic valve disease who were scheduled to undergo cardiac surgery
Who cannot join
- Hemodynamic instability
- Renal insufficiency (serum creatinine level > 133umol/L)
- Known allergy to iodinated contrast agents
- Non-treated hyperthyreosis
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Luzerner Kantonsspital, Department of Cardiology
Lucerne, Canton of Lucerne, 6000
Paul Erne, MD, ++41 41 205 51 06, paul.erne@ksl.ch
Christoph Auf der Maur, MD, ++41 41 2005 51 48
About this study
Official title: Preoperative Assessment of Aortic Valve Stenosis and Coronary Artery Disease: Dual-source Computed Tomography Compared With Invasive Coronary Angiography and Transthoracic Echocardiography
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.
Read the 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.
- Conditions
- Aortic Valve Stenosis, Coronary Disease
- Being tested
- DSCT, TTE
- Keywords
- DSCT, coronary artery disease, aortic valve stenosis
- Medical subject headings
- Aortic Valve Stenosis, Coronary Disease, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DSCT, TTEOther
One assessment each
| Study group | Role | What they receive |
|---|---|---|
| AVS, CAD | Experimental | DSCT Receives: Other: DSCT, TTE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of cardiac imaging in computed tomography
Measured: After comparison of imaging measurements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2008 (estimated)
- Study startMay 2007
- Primary completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luzerner Kantonsspital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Paul Erne, Luzerner Kantonsspital
- Investigators
- Paul Erne, MD, Principal investigator, Luzerner Kantonsspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00767013
- Sponsor's protocol ID
- Cardiac imaging DSCT
- Status last verified
- Apr 2013
- First submitted
- 3 Oct 2008
- Last updated
- 17 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Assessment of Aortic Valve Stenosis and Coronary Artery Disease: Dual-source Computed Tomography Compared With Invasive Coronary Angiography and Transthoracic Echocardiography
- ClinicalTrials.gov ID
- NCT00767013
- Acronym / sponsor ID
- Cardiac imaging DSCT
- Conditions
- Aortic Valve Stenosis, Coronary Disease
- Keywords
- DSCT, coronary artery disease, aortic valve stenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Luzerner KantonsspitalUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Dec 2013 (estimated)
- First posted
- 6 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AVS, CAD | Experimental | Other: DSCT, TTEDSCT |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with aortic valve disease who were scheduled to undergo cardiac surgery
Key exclusion criteria (4 listed)
- Hemodynamic instability
- Renal insufficiency (serum creatinine level > 133umol/L)
- Known allergy to iodinated contrast agents
- Non-treated hyperthyreosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DSCT, TTEOne assessment each | Other | AVS, CAD |
Primary outcome
Quality of cardiac imaging in computed tomography
Time frame: After comparison of imaging measurements
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luzerner Kantonsspital, Department of Cardiology
Lucerne, Switzerland
Paul Erne, MD principal investigator
Luzerner Kantonsspital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DSCT, TTE in people with Aortic Valve Stenosis and Coronary Disease, run by Luzerner Kantonsspital at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of cardiac imaging in computed tomography (time frame: After comparison of imaging measurements). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2013.