Trial Outcomes & Findings for Correlation of Auscultatory Severity of Aortic Stenosis With Trans Thoracic Echocardiography (NCT NCT01605669)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

50 participants

Primary outcome timeframe

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.

Results posted on

2016-09-23

Participant Flow

Participant milestones

Participant milestones
Measure	Aortic Stenosis Patients Patients with varying degrees of aortic stenosis without significant additional valvular disease will be considered eligible for this study.
Overall Study STARTED	50
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Correlation of Auscultatory Severity of Aortic Stenosis With Trans Thoracic Echocardiography

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aortic Stenosis Patients n=50 Participants Patients with varying degrees of aortic stenosis without significant additional valvular disease will be considered eligible for this study.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	36 Participants n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Mean Pressure Gradient >=30mmHg (Positive) n=22 Participants Patients with varying degrees of aortic stenosis without significant additional valvular disease will be considered eligible for this study.	Mean Pressure Gradient <30mmHg (Negative) n=14 Participants
Aortic Stenosis Acceleration Index Compared to Aortic Stenosis Severity ASAI >= 34 (positive)	21 participants	8 participants
Aortic Stenosis Acceleration Index Compared to Aortic Stenosis Severity ASAI < 34 (negative)	1 participants	6 participants

Adverse Events

Aortic Stenosis Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

LCDR William Bennett MD FACC

Naval Medical Center San Deigo

Phone: 619-532-7400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place