- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02685371
Septumverschiebung zur Diagnose einer konstriktiven Perikarditis: Der Einfluss der Quantifizierung der Inspirationsanstrengung auf tiefe Atemmanöver (SCOPED)
Septumverschiebung zur Diagnose einer konstriktiven Perikarditis: Der Einfluss der Quantifizierung der Inspirationsanstrengung auf tiefe Atemmanöver (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.
Studienübersicht
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Quebec
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Sherbrooke, Quebec, Kanada, J1H 5N4
- Paul
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-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Population consists of healthy subjects not know for any cardiovascular disease.
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: CASE_ONLY
- Zeitperspektiven: PROSPECTIVE
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Measurement of the interventricular septum position between inspiration and expiration as assessed by CMR.
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Presence or absence (categorical variable) of a diastolic bounce as assessed by CMR.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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).
Zeitfenster: 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)
Zeitfenster: 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.
Zeitfenster: 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.
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Geschätzt)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- MP-31-2016-1083
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