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

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

Study Overview

• Status: Unknown
• Conditions: Constrictive Pericarditis
• Intervention / Treatment: Behavioral: Breathing

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Recruiting
      • Paul
      • Contact: Paul Farand, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Population consists of healthy subjects not know for any cardiovascular disease.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Behavioral: Breathing; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of the interventricular septum position between inspiration and expiration as assessed by CMR.	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence or absence (categorical variable) of a diastolic bounce as assessed by CMR.	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.	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.	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).	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)	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.	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.

Collaborators and Investigators

• Sponsor: Université de Sherbrooke

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): February 1, 2020
• Study Completion: February 1, 2020

Study Registration Dates

• First Submitted: January 13, 2016
• First Submitted That Met QC Criteria: February 12, 2016
• First Posted (Estimate): February 18, 2016

Study Record Updates

• Last Update Posted (Actual): September 5, 2018
• Last Update Submitted That Met QC Criteria: September 1, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pericarditis; Pericarditis, Constrictive
• Other Study ID Numbers: MP-31-2016-1083

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No