Aortic StenosisSPArKLE-ASNCT00535899
Speckle Tracking Imaging in Patients With Low Ejection Fraction Aortic Stenosis (SPArKLE-AS)
An observational study of Aortic Stenosis, run by The Cleveland Clinic at 1 site in United States.
Trial summary
In patients with aortic stenosis and low ejection fraction, how can we predict who will recover their ejection fraction after aortic valve replacement? We plan to observe 50 patients with Low EF aortic stenosis and perform serial echocardiograms pre and post-aortic valve replacement and analyze regional wall motion… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to not given
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severe aortic stenosis with ejection fraction less than 40% that is schedule to undergo aortic valve replacement
Who cannot join
- Creatinine > 2
- More than moderate mitral, tricuspid, or aortic regurgitation.
- Endocarditis
- Emergent surgery
- Prior sternotimy
Trial locations and contacts
1 site in 1 country.
About this study
In patients with aortic stenosis and low ejection fraction, how can we predict who will recover their ejection fraction after aortic valve replacement? We plan to observe 50 patients with Low EF aortic stenosis and perform serial echocardiograms pre and post-aortic valve replacement and analyze regional wall motion contractility with a new software application called speckle tracking imaging.
Read the detailed description
In patients with severe aortic stenosis and LV dysfunction, 76% of patients have an improvement of ventricular function and NYHA class, after aortic valve replacement. The prognostic indicators of which patients will recover EF post-operatively, has not been fully established, but has been linked to a history of prior MI and pre-operative aortic valve area. Furthermore it is hypothesized that those ventricles that do not recover are fibrosed, either from prior MI or long standing LVH (hypertrophy).
Currently systolic and diastolic function will be measured pre-operatively with standard 2D echo and Doppler. 2D Strain and Strain rate imaging with speckle tracking is a novel method of assessing regional as well as global "contractility". This method overcomes many limitations inherent in assessing myocardial functioning with current methodology, mainly it is reproducible, objective, and is independent of myocardial translation, tethering and furthermore as speckle tracking is derived from B mode images is independent of Doppler angle.The applicability of this technology to patients with aortic valve stenosis and systolic dysfunction and its clinical significance has not been evaluated. We hypothesize that patients with reduced peak systolic strain rate and diastolic strain rates at baseline adjusted for LVEF will have poorer recovery of LVEF than those with relatively preserved strain or strain rate. As this is a pilot study, we plan to prospectively analyze 50 consecutive patients who have severe aortic stenosis and left ventricular systolic dysfunction, EF under 40% with Speckle imaging derived strain rate imaging pre and post-operatively for aortic valve replacement. This would be done as part of routine pre-operative and post-operative transthoracic echocardiography using standard views, with the exception that all studies would need to be done on the GE Vivid 7 digital ultrasound system. Speckle derived imaging data is derived from standard B mode (Grey scale images), with a frame rate of 50 f/s. 3 D images will also be obtained. Post-operative TTE's will be performed before discharge and 4-12 months+/- 30 days after discharge. Baseline characteristics will be taken from the standard pre-operative baseline study including basic 2 D valve area, EF, wall thickness and geometry, and Doppler flow data. Exclusion criteria: Patients with prior cardiac surgery including CABG or other valve replacement, more than mild mitral valve or aortic regurgitation and chronic kidney disease (Cr 1.5), emergent aortic valve replacement, or endocarditis, or CAD on LHC > 50%. Informed consent will be obtain on all patients, and they will only be included if they consent. No surgery will be delayed for purpose of the study if the proper hardware/GE VIVID system is not available.
- Conditions
- Aortic Stenosis
- Keywords
- Aortic stenosis, Speckle tracking imaging, Low ejection fraction, Aortic valve replacement, Strain
- Medical subject headings
- Aortic Valve Stenosis, Sprains and Strains
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
- Study startSep 2007
Why it stopped: unable to find subjects meeting inclusion criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Ryan P Daly, MD, Principal investigator, CCF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00535899
- Sponsor's protocol ID
- 07-578
- Acronym
- SPArKLE-AS
- Status last verified
- May 2008
- First submitted
- 25 Sep 2007
- Last updated
- 26 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Speckle Tracking Imaging in Patients With Low Ejection Fraction Aortic Stenosis (SPArKLE-AS)
- ClinicalTrials.gov ID
- NCT00535899
- Acronym / sponsor ID
- SPArKLE-AS / 07-578
- Conditions
- Aortic Stenosis
- Keywords
- Aortic stenosis, Speckle tracking imaging, Low ejection fraction, Aortic valve replacement, Strain
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: unable to find subjects meeting inclusion criteria
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Sep 2007
- First posted
- 26 Sep 2007 (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.
In patients with aortic stenosis and low ejection fraction, how can we predict who will recover their ejection fraction after aortic valve replacement? We plan to observe 50 patients with Low EF aortic stenosis and perform serial echocardiograms pre and post-aortic valve replacement and analyze regional wall motion contractility with a new software application called speckle tracking imaging.
Detailed description
In patients with severe aortic stenosis and LV dysfunction, 76% of patients have an improvement of ventricular function and NYHA class, after aortic valve replacement. The prognostic indicators of which patients will recover EF post-operatively, has not been fully established, but has been linked to a history of prior MI and pre-operative aortic valve area. Furthermore it is hypothesized that those ventricles that do not recover are fibrosed, either from prior MI or long standing LVH (hypertrophy).
Currently systolic and diastolic function will be measured pre-operatively with standard 2D echo and Doppler. 2D Strain and Strain rate imaging with speckle tracking is a novel method of assessing regional as well as global "contractility". This method overcomes many limitations inherent in assessing myocardial functioning with current methodology, mainly it is reproducible, objective, and is independent of myocardial translation, tethering and furthermore as speckle tracking is derived from B mode images is independent of Doppler angle.The applicability of this technology to patients with aortic valve stenosis and systolic dysfunction and its clinical significance has not been evaluated. We hypothesize that patients with reduced peak systolic strain rate and diastolic strain rates at baseline adjusted for LVEF will have poorer recovery of LVEF than those with relatively preserved strain or strain rate. As this is a pilot study, we plan to prospectively analyze 50 consecutive patients who have severe aortic stenosis and left ventricular systolic dysfunction, EF under 40% with Speckle imaging derived strain rate imaging pre and post-operatively for aortic valve replacement. This would be done as part of routine pre-operative and post-operative transthoracic echocardiography using standard views, with the exception that all studies would need to be done on the GE Vivid 7 digital ultrasound system. Speckle derived imaging data is derived from standard B mode (Grey scale images), with a frame rate of 50 f/s. 3 D images will also be obtained. Post-operative TTE's will be performed before discharge and 4-12 months+/- 30 days after discharge. Baseline characteristics will be taken from the standard pre-operative baseline study including basic 2 D valve area, EF, wall thickness and geometry, and Doppler flow data. Exclusion criteria: Patients with prior cardiac surgery including CABG or other valve replacement, more than mild mitral valve or aortic regurgitation and chronic kidney disease (Cr 1.5), emergent aortic valve replacement, or endocarditis, or CAD on LHC > 50%. Informed consent will be obtain on all patients, and they will only be included if they consent. No surgery will be delayed for purpose of the study if the proper hardware/GE VIVID system is not available.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Severe aortic stenosis with ejection fraction less than 40% that is schedule to undergo aortic valve replacement
Key exclusion criteria (5 listed)
- Creatinine > 2
- More than moderate mitral, tricuspid, or aortic regurgitation.
- Endocarditis
- Emergent surgery
- Prior sternotimy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: unable to find subjects meeting inclusion criteria). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2008.
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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.
Ryan P Daly, MD principal investigator
CCF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis, run by The Cleveland Clinic at 1 site in United States.
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 5 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: stopped early, as of the sponsor's last update on 26 May 2008. 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 United States. 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?
The study was stopped early (reason given: unable to find subjects meeting inclusion criteria). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 26 May 2008.