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Status unknownNCT02685371SCOPEDUpdated Sep 5, 2018

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

An observational study in Constrictive Pericarditis, sponsored by Université de Sherbrooke. Status unknown at 1 site in Canada. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-05.

Sponsored by Université de Sherbrooke · Observational

The sponsor has not verified this record recently (last verified Sep 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Constrictive Pericarditis

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03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

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

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
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Immediate

Secondary outcomes

  1. 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.

    Time frame: Immediate

  2. 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.

    Time frame: Immediate

  3. 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

    Time frame: Immediate

  4. 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

    Time frame: Immediate

  5. 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.

    Time frame: Immediate

  6. 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.

    Time frame: Immediate.

06

Study locations

1 of 1 sites recruiting
  • Paul
    Sherbrooke, Quebec J1H 5N4, Canada
    • Paul Farand, MD · Contact
    Recruiting
07

Registry details

Key details

Study ID
NCT02685371
Lead sponsor
Université de Sherbrooke
Responsible party
Paul Farand (M.D., Université de Sherbrooke) — Principal investigator
First posted
Feb 18, 2016
Start date
Sep 2016
Primary completion
Feb 2020 (estimated)
Completion
Feb 2020
Last update
Sep 5, 2018

Study contacts

Farand Paul, M.D.
Contact
paul.farand@usherbrooke.ca
819-346-1110 ext. 70324
Etienne L Couture, M.D.
Contact
etienne.couture@usherbrooke.ca
819-346-1110 ext. 70324
View the source record on ClinicalTrials.gov ↗

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