Constrictive PericarditisSCOPEDNCT02685371
Septal Shift for the Diagnosis of COnstrictive Pericarditis: The Impact of Inspiratory Effort Quantification on Deep Breathing Manoeuvres
An observational study of Constrictive Pericarditis, run by Université de Sherbrooke at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Constrictive Pericarditis
- What is being tested?
- Breathing
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2016to Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Population consists of healthy subjects not know for any cardiovascular disease.
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Paul
Sherbrooke, Quebec, J1H 5N4
Paul Farand, MD
About this study
Official title: 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.
- Conditions
- Constrictive Pericarditis
- Being tested
- Breathing
- Medical subject headings
- Pericarditis, Constrictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BreathingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediate
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Immediate.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2016 (estimated)
- Study startSep 2016
- Primary completionFeb 2020 (estimated)
- Study completionFeb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Constrictive PericarditisStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Farand, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02685371
- Sponsor's protocol ID
- MP-31-2016-1083
- Acronym
- SCOPED
- Status last verified
- Sep 2018
- First submitted
- 13 Jan 2016
- Last updated
- 5 Sep 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Septal Shift for the Diagnosis of COnstrictive Pericarditis: The Impact of Inspiratory Effort Quantification on Deep Breathing Manoeuvres (SCOPED)
- ClinicalTrials.gov ID
- NCT02685371
- Acronym / sponsor ID
- SCOPED / MP-31-2016-1083
- Conditions
- Constrictive Pericarditis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Feb 2020
- First posted
- 18 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breathing effort type | – | Behavioral: BreathingCurrent 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Population consists of healthy subjects not know for any cardiovascular disease.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BreathingSubjects 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. | Behavioural | Breathing effort type |
Primary outcome
Measurement of the interventricular septum position between inspiration and expiration as assessed by CMR.
Time frame: 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.
6 secondary outcomes
Presence or absence (categorical variable) of a diastolic bounce as assessed by CMR.
Time frame: Immediate
Measurement of the variation of flow through the mitral and tricuspid valve between inspiration and expiration as assessed by CMR.
Time frame: Immediate
Biventricular Index: measurement of the heart contour between inspiration and expiration as assessed by CMR.
Time frame: Immediate
Presence or absence (categorical variable) of diastolic flow reversal in inferior vein cave as assessed by cardiovascular magnetic resonance (CMR).
Time frame: Immediate
Presence or Absence of lack of myocardial slippage in relation to the pericardium as assessed by CMR (tagging sequence)
Time frame: Immediate
Measurement of the relative atrial volume ratio as assessed by CMR.
Time frame: Immediate.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Constrictive Pericarditis, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Farand Paul, M.D. (819-346-1110 ext. 70324, paul.farand@usherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of the interventricular septum position between inspiration and expiration as assessed by CMR. (time frame: Immediate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2018; AzTrials last refreshed its copy on 7 Nov 2026.