- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02685371
폐쇄성 심낭염 진단을 위한 중격 이동: 흡기 노력 정량화가 심호흡 조작에 미치는 영향 (SCOPED)
폐쇄성 심낭염 진단을 위한 중격 이동: 흡기 노력 정량화가 심호흡 조작에 미치는 영향(SCOPED)
This study will evaluate the effect of deep breathing manoeuvres on inter ventricular interdependency physiology. By providing further insight in this basic physiology we want to add more comprehensive data in favor or not of constrictive pericarditis diagnostic criteria currently used in cardiovascular magnetic resonance.
연구 개요
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
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Quebec
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Sherbrooke, Quebec, 캐나다, J1H 5N4
- Paul
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Population consists of healthy subjects not know for any cardiovascular disease.
설명
Inclusion Criteria:
- Men and women between 18 and 80 years old
- Normal transthoracic echocardiogram if older than 41 years old
- Normal standardized history and physical examination
- Normal blood pressure (<130/80)
- Normal 12-lead ECG at rest.
Exclusion Criteria:
- No prior pulmonary or cardiac diseases
- Unexplained symptoms that could be related to a heart or pulmonary problems.
- Symptoms of or active cardiovascular or pulmonary problems
- Hepatic or kidney dysfunction
- Blood cell dyscrasia
- Cardiovascular risk factor (smoking, hypertension, dyslipidemia, diabetes)
- Obesity (BMI > 30)
- Pregnancy or pregnancy in the last year
- Cardiac congenital anomalies discovered during the cardiovascular magnetic resonance
- Current medication with cardiovascular side effects known (diuretics, beta-blockers, calcium channel blockers)
- Contraindication to cardiovascular magnetic resonance
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: CASE_ONLY
- 시간 관점: PROSPECTIVE
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Breathing effort type
Current known criteria for constrictive pericarditis will be test under: 1- spontaneous breathing 2- Breathing with a negative pressure of -15 to - 30 cm of water 3- Breathing with a negative pressure of more than - 30 cm of water. |
Subjects will have to breath 1- Spontaneously 2- to produce a negative pressure of -15 to -30 cm of water and 3- to produce a negative pressure more than -30 cm of water. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Measurement of the interventricular septum position between inspiration and expiration as assessed by CMR.
기간: Immediate
|
Analysis of respiratory-related septal excursion. The relative position of the septum can be obtained by dividing the distance between RV free wall and septum by the biventricular distance. If done during inspiration and expiration, at early ventricular filling, the respiratory-related septal excursion can be quantified. |
Immediate
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Presence or absence (categorical variable) of a diastolic bounce as assessed by CMR.
기간: Immediate
|
Diastolic bounce corresponds to a displacement of inter ventricular septum towards de left ventricle during the protodiastolic period. |
Immediate
|
|
Measurement of the variation of flow through the mitral and tricuspid valve between inspiration and expiration as assessed by CMR.
기간: Immediate
|
Real-Time Phase-Contrast acquisition using a custom-made sequence with through-plane velocity encoding to simultaneously measure MV and TV inflow velocities by prescribing a slice position across both atrioventricular valves from a horizontal long-axis view. |
Immediate
|
|
Biventricular Index: measurement of the heart contour between inspiration and expiration as assessed by CMR.
기간: Immediate
|
Short axis cross section through the mid ventricle. The epicardial tracings is performed in end expiration and end inspiration. The end inspiratory epicardial tracing is divided by the end expiratory epicardial tracing to obtain the biventricular index |
Immediate
|
|
Presence or absence (categorical variable) of diastolic flow reversal in inferior vein cave as assessed by cardiovascular magnetic resonance (CMR).
기간: Immediate
|
Real-time cine imaging of the inferior vein cave for 10 s |
Immediate
|
|
Presence or Absence of lack of myocardial slippage in relation to the pericardium as assessed by CMR (tagging sequence)
기간: Immediate
|
Four-chamber tagged cardiac magnetic resonance image showing lack of slippage between parietal and visceral pericardia. The tag lines break between parietal and visceral pericardia during the cardiac cycle in a normal heart. In constrictive pericarditis, the tag lines do not break. |
Immediate
|
|
Measurement of the relative atrial volume ratio as assessed by CMR.
기간: Immediate.
|
The relative atrial volume ratio (RAR) is defined as the left auricular (LA) volume divided by right auricular (RA) volume. For the LA volume, the biplane area- length method will be used. For the RA volume, the monoplane area-length formula will be used. |
Immediate.
|
공동 작업자 및 조사자
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 (추정된)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- MP-31-2016-1083
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