Clinical trial NCT02685371: Septal Shift for the Diagnosis of COnstrictive Pericarditis: The Impact of Inspiratory Effort Quantification on Deep Breathing Manoeuvres
Official title: Septal Shift for the Diagnosis of COnstrictive Pericarditis: The Impact of Inspiratory Effort Quantification on Deep Breathing Manoeuvres (SCOPED)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Constrictive Pericarditis
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2016-02-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population consists of healthy subjects not know for any cardiovascular disease.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Measurement of the interventricular septum position between inspiration and expiration as assessed by CMR.
timeFrame: Immediate
Secondary outcomes:
measure: Presence or absence (categorical variable) of a diastolic bounce as assessed by CMR.
timeFrame: Immediate
measure: Measurement of the variation of flow through the mitral and tricuspid valve between inspiration and expiration as assessed by CMR.
timeFrame: Immediate
measure: Biventricular Index: measurement of the heart contour between inspiration and expiration as assessed by CMR.
timeFrame: Immediate
measure: Presence or absence (categorical variable) of diastolic flow reversal in inferior vein cave as assessed by cardiovascular magnetic resonance (CMR).
timeFrame: Immediate
measure: Presence or Absence of lack of myocardial slippage in relation to the pericardium as assessed by CMR (tagging sequence)
timeFrame: Immediate
measure: Measurement of the relative atrial volume ratio as assessed by CMR.
timeFrame: Immediate.
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Paul
state: Quebec
Study officials:
References: