Aortic StenosisCassetteNCT01605669

Correlation of Auscultatory Severity of Aortic Stenosis With Trans Thoracic Echocardiography

An observational study of Aortic Stenosis, run by United States Naval Medical Center, San Diego at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Aortic Stenosis
What is being tested?: Tranthoracic Echocardiogram and Cardiac Ascultation Recordings with Electronic stethoscope
Type of treatment: Medical device
How many people: 50 participants
Where: 1 siteUnited States
Study dates: May 2012to Jun 2013
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Study population: Patients with Aortic Stenosis seen in the internal medicine clinic at NMCSD

Who may be able to join

Male and female subjects 18 years of age and older.
Subjects must have asymptomatic Aortic Stenosis documented by prior echocardiographic examination.
Subjects must be able to sit for auscultation examination.
Subject must be able to complete a TTE .
Subjects must voluntarily agree to participate in the study and sign the informed consent and healthcare information authorization forms.

Who cannot join

Subjects with significant additional valvular heart disease.
Subjects with unrecordable heart sounds.
Subjects with known or who may have been previously diagnosed with congenital heart disease.
Subjects with atrial fibrillation.
Subjects with history of cardiac surgery.
Subjects who have conditions which the researcher feels may limit the recordability of the heart sounds or the accuracy of the echocardiogram.

Trial locations and contacts

1 site in 1 country.

United States1 site

Naval Medical Center San Diego
San Diego, California, 92134

Other trials in United States

About this study

According to the 2006 ACC/AHA practice guidelines for valvular heart disease, patients with asymptomatic aortic stenosis(AS) should have screening transthoracic echocardiograms (TTE) performed annually for severe disease, every 1-2 years for moderate disease and every 3-5 years for mild disease. This results in a multitude of screening studies in the investigators patient population. 3M has developed a new stethoscope and phonocardiography software capable of identifying the peak intensity of the AS murmur and tracking it as it moves towards the second heart sound potentially indicating increasing severity of disease. Currently there exists no data to demonstrate that the aortic stenosis acceleration index (ASAI) correlates to disease severity or progression of disease. The ASAI measures the timing of the peak intensity of the systolic murmur and compares it to the total time in systole (S2-x/s2-s1) where s1 is the first heart sound; S2 is the second heart sound and x with the time between S1 and the peak intensity of the murmur. In this study the investigators propose to correlate the ASAI to standard TTE measurements of aortic stenosis severity.

Conditions: Aortic Stenosis
Being tested: Tranthoracic Echocardiogram, Cardiac Ascultation Recordings with Electronic stethoscope
Keywords: Auscultation, Aortic stenosis, computer assisted auscultation, Aortic Stenosis Acceleration Index
Medical subject headings: Aortic Valve Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tranthoracic EchocardiogramOther
standard measurement
Cardiac Ascultation Recordings with Electronic stethoscopeDevice
3M device

Study groups in NCT01605669
Study group	Role	What they receive
Aortic stenosis patients		Patients with varying degrees of aortic stenosis without significant additional valvular disease will be considered eligible for this study. All participants will recieve a transthoracic echocardiogram and recorded cardiac auscultation. Receives: Other: Tranthoracic Echocardiogram; Device: Cardiac Ascultation Recordings with Electronic stethoscope

What is being measured

The primary outcome is the main question the study is designed to answer.

Aortic Stenosis Acceleration Index Compared to Aortic Stenosis Severity
The ASAI measures the timing of the peak intensity of the systolic murmur and compares it to the total time in systole (S2-x/s2-s1) where s1 is the first heart sound; S2 is the second heart sound and x with the time between S1 and the peak intensity of the murmur. Aortic Stenosis severity will be measured by peak and mean aortic valve gradients as well as aortic valve area derived from the continuity equation. ASAI was averaged and compared to the mean aortic gradient. ROC curve was calculated for ASAI predicting a mean gradient of >30mmHg. ASAI of 34 was determined to provide the optimal combination of specificity and sensitivity and therefore set as the cut off point for significant Aortic Stenosis.
Measured: There is a single measurement taken on the day of enrollment. The ascultatory recording and echocardiogram will occur at the same visit. There will be no additional visits or study followup.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2012Jun 2013

First posted25 May 2012 (estimated)
Study startMay 2012
Primary completionJun 2013
Study completionJun 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01605669
Sponsor's protocol ID: NMCSD.2011.0123
Acronym: Cassette
Status last verified: Aug 2016
First submitted: 17 May 2012
Last updated: 23 Sep 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

BRAUNWALD E, GOLDBLATT A, AYGEN MM, ROCKOFF SD, MORROW AG. Congenital aortic stenosis. I. Clinical and hemodynamic findings in 100 patients. II. Surgical treatment and the results of operation. Circulation. 1963 Mar;27:426-62. doi: 10.1161/01.cir.27.3.426. No abstract available.
PubMed 14015087
Bonner AJ Jr, Sacks HN, Tavel ME. Assessing the severity of aortic stenosis by phonocardiography and external carotid pulse recordings. Circulation. 1973 Aug;48(2):247-52. doi: 10.1161/01.cir.48.2.247. No abstract available.
PubMed 4726205
Bonow RO, Carabello BA, Chatterjee K, de Leon AC Jr, Faxon DP, Freed MD, Gaasch WH, Lytle BW, Nishimura RA, O'Gara PT, O'Rourke RA, Otto CM, Shah PM, Shanewise JS; 2006 Writing Committee Members; American College of Cardiology/American Heart Association Task Force. 2008 Focused update incorporated into the ACC/AHA 2006 guidelines for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 1998 Guidelines for the Management of Patients With Valvular Heart Disease): endorsed by the Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. Circulation. 2008 Oct 7;118(15):e523-661. doi: 10.1161/CIRCULATIONAHA.108.190748. Epub 2008 Sep 26. No abstract available.
PubMed 18820172
Stewart BF, Siscovick D, Lind BK, Gardin JM, Gottdiener JS, Smith VE, Kitzman DW, Otto CM. Clinical factors associated with calcific aortic valve disease. Cardiovascular Health Study. J Am Coll Cardiol. 1997 Mar 1;29(3):630-4. doi: 10.1016/s0735-1097(96)00563-3.
PubMed 9060903

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
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Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic

All Aortic Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Correlation of Auscultatory Severity of Aortic Stenosis With Trans Thoracic Echocardiography
ClinicalTrials.gov ID: NCT01605669
Acronym / sponsor ID: Cassette / NMCSD.2011.0123
Conditions: Aortic Stenosis
Keywords: Auscultation, Aortic stenosis, computer assisted auscultation, Aortic Stenosis Acceleration Index
Study type: Observational
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: United States Naval Medical Center, San DiegoUS federal agency
Collaborators: 3M, The Geneva Foundation
Study start: May 2012
Primary completion: Jun 2013 (actual)
Study completion: Jun 2013 (actual)
First posted: 25 May 2012 (estimated)
Results: Posted 5 Nov 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Aortic stenosis patients	–	Other: Tranthoracic Echocardiogram, Device: Cardiac Ascultation Recordings with Electronic stethoscopePatients with varying degrees of aortic stenosis without significant additional valvular disease will be considered eligible for this study. All participants will recieve a transthoracic echocardiogram and recorded cardiac auscultation.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with Aortic Stenosis seen in the internal medicine clinic at NMCSD

Key inclusion criteria (5 listed)

Male and female subjects 18 years of age and older.
Subjects must have asymptomatic Aortic Stenosis documented by prior echocardiographic examination.
Subjects must be able to sit for auscultation examination.
Subject must be able to complete a TTE .
Subjects must voluntarily agree to participate in the study and sign the informed consent and healthcare information authorization forms.

Key exclusion criteria (6 listed)

Subjects with significant additional valvular heart disease.
Subjects with unrecordable heart sounds.
Subjects with known or who may have been previously diagnosed with congenital heart disease.
Subjects with atrial fibrillation.
Subjects with history of cardiac surgery.

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
Tranthoracic Echocardiogramstandard measurement	Other	Aortic stenosis patients
Cardiac Ascultation Recordings with Electronic stethoscope3M device	Device	Aortic stenosis patients

Primary outcome

Aortic Stenosis Acceleration Index Compared to Aortic Stenosis Severity
Time frame: There is a single measurement taken on the day of enrollment. The ascultatory recording and echocardiogram will occur at the same visit. There will be no additional visits or study followup.
The ASAI measures the timing of the peak intensity of the systolic murmur and compares it to the total time in systole (S2-x/s2-s1) where s1 is the first heart sound; S2 is the second heart sound and x with the time between S1 and the peak intensity of the murmur. Aortic Stenosis severity will be measured by peak and mean aortic valve gradients as well as aortic valve area derived from the continuity equation. ASAI was averaged and compared to the mean aortic gradient. ROC curve was calculated for ASAI predicting a mean gradient of >30mmHg. ASAI of 34 was determined to provide the optimal combination of specificity and sensitivity and therefore set as the cut off point for significant Aortic Stenosis.

Results and safety

Results posted to the registry on 5 Nov 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Aortic Stenosis Patients	50	50

Primary outcome: Aortic Stenosis Acceleration Index Compared to Aortic Stenosis Severity

Time frame: There is a single measurement taken on the day of enrollment. The ascultatory recording and echocardiogram will occur at the same visit. There will be no additional visits or study followup.. Number. Unit: participants

Measure	Mean Pressure Gradient >=30mmHg (Positive) n = 22	Mean Pressure Gradient <30mmHg (Negative) n = 14
ASAI >= 34 (positive)	21	8
ASAI < 34 (negative)	1	6

Mean Pressure Gradient >=30mmHg (Positive): Percentage Sensitivity: 85.7
Mean Pressure Gradient <30mmHg (Negative): Percent Specificity: 72.4
Mean Pressure Gradient >=30mmHg (Positive) vs Mean Pressure Gradient <30mmHg (Negative): Percent Error Rate: 25

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aortic Stenosis Patients	0 of 50 (0%)	0 of 50 (0%)	Not reported

Limitations and caveats (from the sponsor): Patients with significant concomitant valvular disease were not evaluated. The software does not provide immediate feedback on the severity of the stenosis. Multiple early recordings had artifact noise rquiring modificaiton of recording techniques.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 14015087BRAUNWALD E, GOLDBLATT A, AYGEN MM, ROCKOFF SD, MORROW AG. Congenital aortic stenosis. I. Clinical and hemodynamic findings in 100 patients. II. Surgical treatment and the results of operation. Circulation. 1963 Mar;27:426-62. doi: 10.1161/01.cir.27.3.426. No abstract available.
Background: PubMed 4726205Bonner AJ Jr, Sacks HN, Tavel ME. Assessing the severity of aortic stenosis by phonocardiography and external carotid pulse recordings. Circulation. 1973 Aug;48(2):247-52. doi: 10.1161/01.cir.48.2.247. No abstract available.
Background: PubMed 18820172Bonow RO, Carabello BA, Chatterjee K, de Leon AC Jr, Faxon DP, Freed MD, Gaasch WH, Lytle BW, Nishimura RA, O'Gara PT, O'Rourke RA, Otto CM, Shah PM, Shanewise JS; 2006 Writing Committee Members; American College of Cardiology/American Heart Association Task Force. 2008 Focused update incorporated into the ACC/AHA 2006 guidelines for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 1998 Guidelines for the Management of Patients With Valvular Heart Disease): endorsed by the Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. Circulation. 2008 Oct 7;118(15):e523-661. doi: 10.1161/CIRCULATIONAHA.108.190748. Epub 2008 Sep 26. No abstract available.
Background: PubMed 9060903Stewart BF, Siscovick D, Lind BK, Gardin JM, Gottdiener JS, Smith VE, Kitzman DW, Otto CM. Clinical factors associated with calcific aortic valve disease. Cardiovascular Health Study. J Am Coll Cardiol. 1997 Mar 1;29(3):630-4. doi: 10.1016/s0735-1097(96)00563-3.
Individual participant dataSharing planned: No

Related trials for Aortic Stenosis

Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic

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.

William E Bennett, MD principal investigator

United States Naval Medical Center, San Diego

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 United States Naval Medical Center, San Diego 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 23 Sep 2016. 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?

Yes. Results are posted in the registry (first posted 5 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Aortic Stenosis Acceleration Index Compared to Aortic Stenosis Severity (time frame: There is a single measurement taken on the day of enrollment. The ascultatory recording and echocardiogram will occur at the same visit. There will be no additional visits or study followup.). 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 NCT01605669, 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 23 Sep 2016.