Correlation of Auscultatory Severity of Aortic Stenosis With Trans Thoracic Echocardiography (CASSETTE) (Cassette)
| Tracking Information | |||||
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| First Received Date ICMJE | May 17, 2012 | ||||
| Last Updated Date | April 30, 2013 | ||||
| Start Date ICMJE | May 2012 | ||||
| Primary Completion Date | November 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. ] [ Designated as safety issue: No ] 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. |
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| Original Primary Outcome Measures ICMJE |
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. ] [ Designated as safety issue: No ] 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 arotic valve area derived from the continuity equation. |
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| Change History | Complete list of historical versions of study NCT01605669 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Correlation of Auscultatory Severity of Aortic Stenosis With Trans Thoracic Echocardiography (CASSETTE) | ||||
| Official Title ICMJE | Correlation of Auscultatory Severity of Aortic Stenosis With Trans Thoracic Echocardiography | ||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients with Aortic Stenosis seen in the internal medicine clinic at NMCSD |
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| Condition ICMJE | Aortic Stenosis | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Aortic stenosis patients
Patients with varying degrees of aortic stenosis without significant additional valvular disease will be considered eligible for this study. |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 50 | ||||
| Completion Date | November 2012 | ||||
| Primary Completion Date | November 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01605669 | ||||
| Other Study ID Numbers ICMJE | NMCSD.2011.0123 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | William, United States Naval Medical Center, San Diego | ||||
| Study Sponsor ICMJE | United States Naval Medical Center, San Diego | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | United States Naval Medical Center, San Diego | ||||
| Verification Date | April 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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