- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02141269
Comparitive Effectiveness of PME Versus Transthoracic Echocardiogram (TTE)
Comparative Effectiveness of Pocket, Mobile, Hand-held Echocardiography and Conventional Transthoracic Echocardiography in an Inpatient and Outpatient Clinical Setting
A new hand held pocket echo device (GE Vscan) has now become available to clinicians, with limited data available comparing the effectiveness of this device as a screening tool when compared to traditional transthoracic echocardiography (TTE).
The investigators are evaluating the effectiveness of this hand-held echo (HHE) device in detecting cardiac pathology in a both an inpatient and outpatient clinical setting as compared to a comprehensive TTE evaluation.
연구 개요
상태
정황
상세 설명
A new hand held pocket echo device (GE Vscan) has now become available to clinicians, with limited data available comparing the effectiveness of this device as a screening tool when compared to TTE.
We are evaluating the effectiveness of this HHE device in detecting cardiac pathology in a both an inpatient and outpatient clinical setting as compared to a comprehensive TTE evaluation.
This study compares the images from the two modalities with regards to multiple parameters typically evaluated by traditional TTE. This would include the following:
- Ejection fraction: estimates how well the heart is squeezing/functioning.
- Segmental wall motion abnormalities: if one wall of the heart is not moving well, this suggests that part of the heart is not getting enough blood supply and could represent a blockage in a blood vessel supplying the heart or in other terms a heart attack.
- Left ventricular end-diastolic dimension: allows us to see if the heart is dilated
- Inferior vena cava size: the size of this great vein can help estimate if patient has too much fluid in their vascular bed.
- Aortic valve pathology: whether or not there is thickening of the valve or impairment of it's opening.
- Mitral valve pathology: whether or not the valve is significantly thickened or with impaired closing and opening.
- Pericardial effusion: excessive fluid in the sack around the heart.
The images obtained on the HHE will be evaluated by two experienced echocardiographers as well as two cardiology fellows who have obtained training in image acquisition and interpretation. The readers of the HHE images are blinded to the TTE results, and vice versa.
A comparison of these individual parameters on HHE and TTE allows us to validate this new, convenient screening tool in detecting cardiac pathology.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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California
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La Jolla, California, 미국, 92037
- Scripps Green Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- All subjects with an order for a routine transthoracic echocardiogram based on clinical indications.
- Vscan images will be obtained to evaluate multiple parameters (noted on research summary).
- Immediately after Vscan imaging, a complete transthoracic echocardiogram will be performed.
- Images will be compared between the Vscan device and the traditional transthoracic echocardiogram.
Exclusion Criteria:
- Subjects who had a limited transthoracic echocardiography (i.e limited views)
- Vscan imaging not attempted for a certain parameter
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Comparison of HHE and TTE results
기간: 1 time
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Comparison of the two modalities includes accuracy, sensitivity, specificity, proportion visualized, and inter-observer variability.
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1 time
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Eric Topol, MD, Scripps Health
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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