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

Constrictive Pericarditis Clinical Trial

— SCOPED  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02685371
• Other study ID #: MP-31-2016-1083
• Status: Recruiting
• Start date: September 2016
• Est. completion date: February 2020

Study information

• Verified date: September 2018
• Source: Université de Sherbrooke
• Contact: Farand Paul, M.D.
• Phone: 819-346-1110
• Email: paul.farand[@]usherbrooke.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Constrictive Pericarditis
• Pericarditis

Intervention

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.

Locations

Country	Name	City	State
Canada	Paul	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.