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临床试验/NCT02685371
NCT02685371Unknown不适用

Septal Shift for the Diagnosis of COnstrictive Pericarditis: The Impact of Inspiratory Effort Quantification on Deep Breathing Manoeuvres (SCOPED)

Université de Sherbrooke1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Measurement of the interventricular septum position between inspiration and expiration as assessed by CMR.

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Measurement of the interventricular septum position between inspiration and expiration as assessed by CMR.

时间窗: 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.

次要结局

  • Biventricular Index: measurement of the heart contour between inspiration and expiration as assessed by CMR.(Immediate)
  • Presence or absence (categorical variable) of a diastolic bounce as assessed by CMR.(Immediate)
  • Presence or Absence of lack of myocardial slippage in relation to the pericardium as assessed by CMR (tagging sequence)(Immediate)
  • Measurement of the relative atrial volume ratio as assessed by CMR.(Immediate.)
  • Measurement of the variation of flow through the mitral and tricuspid valve between inspiration and expiration as assessed by CMR.(Immediate)
  • Presence or absence (categorical variable) of diastolic flow reversal in inferior vein cave as assessed by cardiovascular magnetic resonance (CMR).(Immediate)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Paul Farand

M.D.

Université de Sherbrooke

研究点 (1)

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