- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02037178
Screening for Arteriopathy in General Medicine: a Preliminary Feasibility Study (DAG)
연구 개요
상태
상세 설명
The secondary objectives of this study are:
A. To assess the prevalence of Abdominal Aortic Aneurysm (AAA) detected by ultrasound measurement of the anterior and posterior longitudinal outer diameter of the sub-renal abdominal aorta in a high cardiovascular risk population consulting with general practitioners (defined according to recommendations stated by the French Society of Vascular Medicine).
B. To assess the prevalence of Peripheral Obliterative Arteriopathy of the Legs (POAL) by measuring the Systolic Pressure Index (SPI) at the toe (ratio of arterial pressure in upper limbs versus lower limbs). Measures are made by a general practitioner in the same population.
C. To assess the quality and interpretability of ultrasound recordings and ultrasound acquistion failure rate. These second measures are made by an expert in vascular medecine. This evaluation with use a 3-level scale:
- appropriate image was not obtained or not recognized expert - uninterpretable
- poor image quality - interpretable
- image of good or very good quality - interpretable
D. To calculate the impact of risk cofactors such as hypertension , smoking, age and family history among patients diagnosed with AAA.
E. Evaluation of general practitioner training from a qualitative and quantitative point of view after 4 h of training organized by Dr. Bobbià .
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Nîmes Cedex 9, 프랑스, 30029
- CHRU de Nîmes - Hôpital Universitaire Carémeau
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Nîmes cedex 2, 프랑스, 30908
- Centre Médico Sportif
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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:
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient falls into one of the following 4 groups as defined by the French Society of Vascular Medecin (2006):
- (1) Men and women 60-75 years of age who are active smokers or ex-smokers
- (2) Men over 75 years of age
- (3) Women over 75 years of age who smoke and who have known hypertension
- (4) Men and women over 50 years of age with a family history of aneurysm of the abdominal aorta
Exclusion Criteria:
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
- The subject has an allergy to the gel used for ultrasound examination.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
---|---|
The study population
See inclusion/exclusion criteria. Intervention: First ultrasound reading Intervention: Second ultrasound interpretation |
First ultrasound reading of the sub-renal abdominal aorta by a general practitioner.
The untrasound images recorded by general practitioners will be interpreted a second time by an expert in vascular medecine, and evaluated for their image quality.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Largest external antero-posterior diameter of the sub-renal abdominal aorta (mm)
기간: Baseline (day 0)
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Measures made using both cross-sectional and longitudinal ultrasounds.
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Baseline (day 0)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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SPI at the toe (mmHg)
기간: baseline (Day 0)
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baseline (Day 0)
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Largest external antero-posterior diameter of the sub-renal abdominal aorta (mm) : second interpretation of echographic material by a second expert
기간: maximum of three months
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Measures made using both cross-sectional and longitudinal ultrasounds.
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maximum of three months
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Ultrasound quality as assessed by the second expert
기간: maximum of three months
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This evaluation with use a 3-level scale:
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maximum of three months
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기타 결과 측정
결과 측정 |
기간 |
---|---|
나이
기간: 기준선(0일)
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기준선(0일)
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Smoker? yes/no
기간: baseline (day 0)
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baseline (day 0)
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Hypertension? yes/no
기간: baseline (day 0)
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baseline (day 0)
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- LOCAL/2013/JLLD-01
- 2013-A01583-42 (기타 식별자: RCB number)
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Peripheral Obliterative Arteriopathy에 대한 임상 시험
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C. R. Bard완전한
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Mayo Clinic초대로 등록
First ultrasound reading에 대한 임상 시험
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Academisch Medisch Centrum - Universiteit van Amsterdam...완전한
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Ajou University School of Medicine종료됨
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Children's Hospital Medical Center, Cincinnati모집하지 않고 적극적으로
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