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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02685371
Acronym
SCOPED
Enrollment
60
Registered
2016-02-18
Start date
2016-09-30
Completion date
2020-02-29
Last updated
2018-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constrictive Pericarditis

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.

Interventions

BEHAVIORALBreathing

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.

Sponsors

Université de Sherbrooke
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

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

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

Countries

Canada

Contacts

Primary ContactFarand Paul, M.D.
paul.farand@usherbrooke.ca819-346-1110
Backup ContactEtienne L Couture, M.D.
etienne.couture@usherbrooke.ca819-346-1110

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026