- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02685371
Septumförskjutning för diagnos av konstriktiv perikardit: Inverkan av kvantifiering av inspiratorisk ansträngning på djupandningsmanövrar (SCOPED)
Septumskifte för diagnos av konstriktiv perikardit: Inverkan av kvantifiering av inspiratorisk ansträngning på djupandningsmanövrar (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.
Studieöversikt
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
Quebec
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Sherbrooke, Quebec, Kanada, J1H 5N4
- Paul
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Population consists of healthy subjects not know for any cardiovascular disease.
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: CASE_ONLY
- Tidsperspektiv: PROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
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. |
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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Measurement of the interventricular septum position between inspiration and expiration as assessed by CMR.
Tidsram: 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. |
Immediate
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Presence or absence (categorical variable) of a diastolic bounce as assessed by CMR.
Tidsram: Immediate
|
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.
Tidsram: Immediate
|
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.
Tidsram: Immediate
|
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).
Tidsram: Immediate
|
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)
Tidsram: Immediate
|
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.
Tidsram: 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. |
Immediate.
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Beräknad)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- MP-31-2016-1083
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