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

• Conditions: Constrictive Pericarditis
• Interventions: Behavioral: Breathing

• Registration Number: NCT02685371
• Lead Sponsor: Université de Sherbrooke

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-13
• Study First Submitted QC: 2016-02-12
• Study First Posted: 2016-02-18
• Study Start: 2016-09
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-01
• Last Update Posted: 2018-09-05
• Primary Completion: 2020-02
• Study Completion: 2020-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Breathing effort type	Breathing	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Biventricular Index: measurement of the heart contour between inspiration and expiration as assessed by CMR.	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
Presence or absence (categorical variable) of a diastolic bounce as assessed by CMR.	Immediate	Diastolic bounce corresponds to a displacement of inter ventricular septum towards de left ventricle during the protodiastolic period.
Presence or Absence of lack of myocardial slippage in relation to the pericardium as assessed by CMR (tagging sequence)	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.
Measurement of the relative atrial volume ratio as assessed by CMR.	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.
Measurement of the variation of flow through the mitral and tricuspid valve between inspiration and expiration as assessed by CMR.	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.
Presence or absence (categorical variable) of diastolic flow reversal in inferior vein cave as assessed by cardiovascular magnetic resonance (CMR).	Immediate	Real-time cine imaging of the inferior vein cave for 10 s

Trial Locations

Locations (1)

Paul; 🇨🇦 Sherbrooke, Quebec, Canada