Aortic StenosisNCT00774657
Ventricular Remodeling In Patients With Aortic Stenosis Assessed Echocardiography
An observational study of Aortic Stenosis, run by Lahey Clinic at 1 site in United States.
Trial summary
This preliminary study will compare the effectiveness of two-dimensional and three-dimensional echocardiographic measurements of wall thickness and left ventricular mass in patients with Aortic Stenosis Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Aortic Stenosis
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Feb 2012
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Lahey Clinic patients who have been referred to the echocardiography lab for clinical indications, found to have a aortic stenosis
Who may be able to join
- Subjects more than 18 yrs of age through 90 yrs of age
- Both male and female
- Patients with moderate or severe isolated Aortic Stenosis
- Patients who have been referred for both two-dimensional and three- dimensional echocardiographies.
Who cannot join
- Poor acoustic windows
- h/o CAD and wall motion abnormality
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patterns Of Left Ventricular Remodeling In Patients With Aortic Stenosis Assessed By Two-Dimensional And Three-Dimensional Echocardiography
This preliminary study will compare the effectiveness of two-dimensional and three-dimensional echocardiographic measurements of wall thickness and left ventricular mass in patients with Aortic Stenosis
Read the detailed description
This study will evaluate left ventricular patterns of remodeling and hypertrophy in patients with aortic stenosis, and compare two-dimensional echocardiography measurements (wall thickness) with three-dimensional echocardiography data(left ventricular mass). Along with a second objective to assess Doppler diastolic filling indices associated with the various patterns of left ventricular remodeling.
Previous studies(see reference list) were primarily derived from two-dimensional echo data set(based on wall thickness). Various patterns of left ventricular remodeling have been described in response to increased pressure overload.
Three-dimensional echocardiography is a relatively new technique that is being increasingly used in the Echocardiography Lab in selected patients. This technique holds promise of being more accurate for volume-related measurements than the standard 2-dimensional echocardiography techniques.
- Conditions
- Aortic Stenosis
- Keywords
- Aortic Stenosis, Valvular heart disease, Heart disease, Cardiovascular disease, Two dimensional echocardiography, Three dimensional echocardiography
- Medical subject headings
- Aortic Valve Stenosis, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate 2-dimensional and 3-dimensional echocardiography for LV patterns of remodeling and hypertrophy
Measured: 1 hour
Secondary outcomes (1)
Assess doppler diastolic filling indices for patterns of LV remodeling
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionFeb 2012
- Study completionFeb 2012
Why it stopped: Unable to identify and recruit suitable study subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Aortic 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lahey Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Tufts Medical Center
- Responsible party
- Sponsor
- Investigators
- Sherif B. Labib, M.D., Principal investigator, Lahey Clinic, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00774657
- Sponsor's protocol ID
- 2008-090
- Status last verified
- Feb 2012
- First submitted
- 16 Oct 2008
- Last updated
- 17 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Faggiano P, Rusconi C, Ghizzoni G, Sabatini T. Left ventricular remodeling and function in adult aortic stenosis. Angiology. 1994 Dec;45(12):1033-8. doi: 10.1177/000331979404501206.
PubMed 7985830Kupari M, Turto H, Lommi J. Left ventricular hypertrophy in aortic valve stenosis: preventive or promotive of systolic dysfunction and heart failure? Eur Heart J. 2005 Sep;26(17):1790-6. doi: 10.1093/eurheartj/ehi290. Epub 2005 Apr 28.
PubMed 15860517Salcedo EE, Korzick DH, Currie PJ, Stewart WJ, Lever HM, Goormastic M. Determinants of left ventricular hypertrophy in patients with aortic stenosis. Cleve Clin J Med. 1989 Sep;56(6):590-6. doi: 10.3949/ccjm.56.6.590.
PubMed 2530009Jenkins C, Bricknell K, Hanekom L, Marwick TH. Reproducibility and accuracy of echocardiographic measurements of left ventricular parameters using real-time three-dimensional echocardiography. J Am Coll Cardiol. 2004 Aug 18;44(4):878-86. doi: 10.1016/j.jacc.2004.05.050.
PubMed 15312875
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patterns Of Left Ventricular Remodeling In Patients With Aortic Stenosis Assessed By Two-Dimensional And Three-Dimensional Echocardiography
- ClinicalTrials.gov ID
- NCT00774657
- Acronym / sponsor ID
- 2008-090
- Conditions
- Aortic Stenosis
- Keywords
- Aortic Stenosis, Valvular heart disease, Heart disease, Cardiovascular disease, Two dimensional echocardiography, Three dimensional echocardiography
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Unable to identify and recruit suitable study subjects
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Lahey ClinicUniversity, hospital or other
- Collaborators
- Tufts Medical Center
- Study start
- Sep 2008
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 17 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.
This preliminary study will compare the effectiveness of two-dimensional and three-dimensional echocardiographic measurements of wall thickness and left ventricular mass in patients with Aortic Stenosis
Detailed description
This study will evaluate left ventricular patterns of remodeling and hypertrophy in patients with aortic stenosis, and compare two-dimensional echocardiography measurements (wall thickness) with three-dimensional echocardiography data(left ventricular mass). Along with a second objective to assess Doppler diastolic filling indices associated with the various patterns of left ventricular remodeling.
Previous studies(see reference list) were primarily derived from two-dimensional echo data set(based on wall thickness). Various patterns of left ventricular remodeling have been described in response to increased pressure overload.
Three-dimensional echocardiography is a relatively new technique that is being increasingly used in the Echocardiography Lab in selected patients. This technique holds promise of being more accurate for volume-related measurements than the standard 2-dimensional echocardiography techniques.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lahey Clinic patients who have been referred to the echocardiography lab for clinical indications, found to have a aortic stenosis
Key inclusion criteria (4 listed)
- Subjects more than 18 yrs of age through 90 yrs of age
- Both male and female
- Patients with moderate or severe isolated Aortic Stenosis
- Patients who have been referred for both two-dimensional and three- dimensional echocardiographies.
Key exclusion criteria (2 listed)
- Poor acoustic windows
- h/o CAD and wall motion abnormality
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
Evaluate 2-dimensional and 3-dimensional echocardiography for LV patterns of remodeling and hypertrophy
Time frame: 1 hour
1 secondary outcome
Assess doppler diastolic filling indices for patterns of LV remodeling
Time frame: 1 hour
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2012.
- Background: PubMed 7985830Faggiano P, Rusconi C, Ghizzoni G, Sabatini T. Left ventricular remodeling and function in adult aortic stenosis. Angiology. 1994 Dec;45(12):1033-8. doi: 10.1177/000331979404501206.
- Background: PubMed 15860517Kupari M, Turto H, Lommi J. Left ventricular hypertrophy in aortic valve stenosis: preventive or promotive of systolic dysfunction and heart failure? Eur Heart J. 2005 Sep;26(17):1790-6. doi: 10.1093/eurheartj/ehi290. Epub 2005 Apr 28.
- Background: PubMed 2530009Salcedo EE, Korzick DH, Currie PJ, Stewart WJ, Lever HM, Goormastic M. Determinants of left ventricular hypertrophy in patients with aortic stenosis. Cleve Clin J Med. 1989 Sep;56(6):590-6. doi: 10.3949/ccjm.56.6.590.
- Background: PubMed 15312875Jenkins C, Bricknell K, Hanekom L, Marwick TH. Reproducibility and accuracy of echocardiographic measurements of left ventricular parameters using real-time three-dimensional echocardiography. J Am Coll Cardiol. 2004 Aug 18;44(4):878-86. doi: 10.1016/j.jacc.2004.05.050.
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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.
Sherif B. Labib, M.D. principal investigator
Lahey Clinic, Inc.
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 Lahey 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 4 inclusion and 2 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: withdrawn, as of the sponsor's last update on 17 Feb 2012. 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 withdrawn before enrolling participants, so there are no results.
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.
What does the primary outcome measure?
Evaluate 2-dimensional and 3-dimensional echocardiography for LV patterns of remodeling and hypertrophy (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00774657, which also lists 4 linked publications.
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 Feb 2012.