- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02860182
Mechanical Characterization of Ascending Aorta in Patients With and Without Aortic Dissection
Mechanical Characterization of Ascending Aorta in Patients With Acute Type A Dissection and in Healthy Control Group Combined to Structural and Ultrastructural Analysis of Aortic Tissue
연구 개요
상세 설명
Objectives: this study aims to characterize mechanical properties of ascending aorta (AA) in patients, with and without aortic dissection.
Materials and methods : comprised an in vivo and ex vivo studies performed in 2 groups of patients : (1) patients admitted for acute type A dissection and treated with surgical procedure ; (2) healthy control group selected among patients without any ascending aorta pathology and who underwent transoesophageal echocardiography for various indications.
In vivo study : Strain, distensibility, stiffness index and pressure strain elastic modulus (Ep) were calculated from aortic diameter variation in response to pressure variation. Aortic diameters were measured using transoesophageal echocardiography.
Ex vivo study : biaxial tensile testing were performed on aortic wall samples. Dissected aortic samples were collected from patients who underwent surgical repair and healthy samples from unused donors hearts and lungs. Mechanical characterization was combined to a histological and microstructural analysis of aortic wall. The latter was conducted using multiphoton microscopy to visualize elastin and collagen fibers.
Results :
In vivo study: 22 patients in healthy control group and 13 patients in dissection group were prospectively investigated.
In vitro study : Biaxial testing was performed on 4 samples of dissected aorta and 6 samples of non dissected aorta. Anisotropic and non linear behavior of aortic tissue was shown in the 2 types of samples. Dissected tissue were stiffer than the intimal flap which was in turn stiffer than non dissected tissue.
Histological data showed that in dissection group global elastin density was lower than in control. Microstructural analysis in dissection specimens revealed a higher collagen signal in the media mainly in circumferential plane, contrasting with a roughly similar intensity between the two planes in control. This higher signal reflects higher collagen fiber density and/or thicker fibers in this tunica.
Conclusion : Both in vivo and in vitro data revealed that dissected aorta was stiffer than healthy ascending aorta. These findings has consequences on the choice of futur devices dedicated to AA
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
-
-
-
Marseille, 프랑스, 13354
- 모병
- Assistance Publique Hopitaux de Marseille
-
연락하다:
- Mourad BOUFI
- 전화번호: +33 0491382747
- 이메일: drci@ap-hm.fr
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Patients aged 50 to 85 years
- The information given search,
- Aortic dissection evolving for less than 15 days confirmed
Exclusion Criteria:
- the acute aortic dissections against-indicated for aortic surgery (patient age, stroke or multiple organ failure)
- Iatrogenic dissections,
- Dissections related to congenital or hereditary disorder (abnormal connective tissue) or those occurring in subjects with a bicuspid aortic valve,
- Intramural hematomas type A,
- Patients under guardianship or trusteeship deprived of liberty.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
experimental
patients with acute type A dissection
|
|
|
control
patients without any pathology of the ascending aorta, but having the same characteristics as the sick patients, in terms of age and vascular risk factors including high blood pressure
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
measure the elastic properties of aortic wall
기간: one day
|
The distensibility, aortic strain will be measured as a function of changes of aortic diameter and pulse pressure.
|
one day
|
|
Measurement of aortic diameters
기간: one day
|
The measurement will be done by transesophageal echocardiography simultaneously to the cuff brachial artery pressure.
|
one day
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (예상)
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
이 연구와 관련된 용어
기타 연구 ID 번호
- 2013-08
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. .
급성 유형 A 해부에 대한 임상 시험
-
Ceric SàrlEuropean Cardiovascular Research Center모병B형 대동맥 박리 | 대동맥의 관통성 궤양 | 동맥류 대동맥 | Type A 수리 후 잔여 박리프랑스