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Outcome of Preserved Mitral Valve Apparatus During Mitral Valve Replacement (EarlyOutcome)

23. Juni 2022 aktualisiert von: Hamdy Dosoky Ibraheem Elayouty, Suez Canal University

Outcome of Preservation of Mitral Valve Leaflets During Mitral Replacement

Are there differences in outcome of mitral valve replacement with preservation of mitral apparatus among rheumatic and/or ischemic mitral lesions?.

Mitral valve replacement with preservation of leaflets, and added coronary artery-bypass surgery, when indicated, is it a feasible and reproducible procedure?.

The study was designed to compare outcome after prosthetic mitral replacement with preservation of mitral apparatus for rheumatic valve disease with outcome of replacement for ischemic myocardium and mitral valve disease, The outcomes will be guided by clinical assessment. and echo-cardiograph.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Objectives: The aim is to compare outcome of modified preservation of mitral valve apparatus during prosthetic mitral replacement for rheumatic versus myocardial ischemia &mitral valve disease.

Methods ;This prospective cross-sectional comparative study will include 50 patients with isolated rheumatic mitral valve disease (group A) and 50 patients with mitral disease and myocardial ischemia (group B), surgery is expected to be performed between 2017 and 2020 at one center. All patients will have modified preservation of mitral apparatus during prosthetic mitral replacement. Additionally, group B patients will have bypass grafts to left anterior descending and/or posterior descending / right coronary artery. Data will be collected and analyzed.

The Institutional Review Board (IRB), Ethics Committee (EC)-approval and consent of each patient were obtained.

Criteria for inclusion of patients and exclusion of others were determined according to the guide lines.

Statistical analysis::

Qualitative variables and their association among both groups were studied by applying Chi-square test and Fisher Exact test. Quantitative variables among both groups were compared by applying independent samples t-test. P < 0.05 values mean statistically-significant results.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

100

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Ägypten
      • Ismailia, Ägypten, +064
        • Suez Canal University
      • Ismailia, Ägypten, 002-064
        • Suez Canal University

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

30 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria::

Mitral stenosis (MS)

  • symptoms are severely limiting and cannot be managed with diuresis and heart rate control.

Mitral regurgitation(MR):

* acute severe MR require surgical correction for hemo-dynamics and relief of symptoms .

Chronic primary mitral regurgitation:

* rheumatic heart disease: replacement before irreversible changes occur can be curative.

Mixed Mitral Stenosis and Mitral Regurgitation:

  • If beta blockers and diuretics do not relieve symptoms, replacement should be performed only in patients who have severe limiting symptoms.
  • Myocardial ischemia associating or complicated with miral valve disease.

Exclusion criteria

  • Patients showing good response to medical therapy, and Cases complicated by:
  • ineffective endocarditis,
  • previous myocardial re-vascularization
  • ischemic ventricular septal defect,
  • left ventricular aneurysm,
  • Ruptured papillary muscles of mitral apparatus.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Schein-Komparator: Group A
50 patients with isolated rheumatic mitral valve disease (group A)
Gerät: St.Jude bi leaflet prosthetic mitral valve to replace the diseased valve with preservation of both leaflets
St.Jude prosthetic(FDA approved) mitral valve replacement with or without coronary artery bypass grafts
Andere Namen:
  • St.Jude bi leaflet prosthesis to replace diseased valve with preservation of leaflets with Myocardial re-vascularization
  • St.Jude prosthetic mitral replacement with preservation of valve apparatus and bypass grafts for associated coronary artery disease
Sonstiges: Group B
50 patients with mitral disease and myocardial ischemia (group B)
Gerät: St.Jude bi leaflet prosthetic mitral valve to replace the diseased valve with preservation of both leaflets
St.Jude prosthetic(FDA approved) mitral valve replacement with or without coronary artery bypass grafts
Andere Namen:
  • St.Jude bi leaflet prosthesis to replace diseased valve with preservation of leaflets with Myocardial re-vascularization
  • St.Jude prosthetic mitral replacement with preservation of valve apparatus and bypass grafts for associated coronary artery disease

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Smoking index
Zeitfenster: One week before surgery(or during first clinical visit) .
Number of Packs every day X number of years of smoking= Pack.year,
One week before surgery(or during first clinical visit) .
Age and gender for each participant
Zeitfenster: One week before surgery .
Males above 40 years and Females above 45 years need pre-operative coronary angio-graph
One week before surgery .
For each participant: pathological:type of mitral valve lesion
Zeitfenster: Seven days before surgery .
severe stenosis with mitral area < 1 cm square, severe regurgitation, or mixed lesions
Seven days before surgery .
For each participant: etiological :type of mitral valve lesion
Zeitfenster: Seven days before surgery .
Rheumatic: distorted thickened leaflets,thickened fibrosed chordae
Seven days before surgery .
For each participant: etiological :type of mitral valve lesion
Zeitfenster: Seven days before surgery- echo-cardiograph.
Rheumatic: distorted thickened leaflets,thickened fibrosed chordae or ischemic incompetence
Seven days before surgery- echo-cardiograph.
For each participant:, assessing sub-valvular apparatus
Zeitfenster: One week before surgery. with Echo-cardiograph.
Thickened chordae, ruptured chordae, ischemia of papillary muscles or lateral ventricular wall.
One week before surgery. with Echo-cardiograph.
Abascal echo-cardiographic mitral valve score (Wilkins score)
Zeitfenster: One week before surgery.with Echo-cardiograph
:if score is 8 or less it is good for balloon valvo-plasty, if > 8 surgery is recommended ( leaflet mobility, thickness and calcification. Fourthly, sub-valvular thickening., higher scores = more deterioration
One week before surgery.with Echo-cardiograph
left ventricular wall motion abnormality
Zeitfenster: one week before surgery - with an echo-cardiograph
hypokinesia, Akinesia, Dyskinesia of certain segment(s)
one week before surgery - with an echo-cardiograph
Number of participants with Signs of left ventricular dysfunction
Zeitfenster: seven days before surgery echo-cardiograph examination
low ejection fraction <52%, low stroke volume< 70 ml, low cardiac output <5 litres per minute
seven days before surgery echo-cardiograph examination
Number of participants with pre-operative coronary artery disease
Zeitfenster: seven days before surgery, coronary angio-graph
Expected on clinical bases and .proved by Echo-cardiograph-findings
seven days before surgery, coronary angio-graph
Number of participants with pre-operative ischemic complications
Zeitfenster: seven days before surgery echo-cardiograph examination
left ventricular thrombi, septal and left ventricular wall thickness in mm .
seven days before surgery echo-cardiograph examination
Assessment of any evolving new prosthetic valve dysfunction
Zeitfenster: intra-operative trans-esophageal echo-cardiograph examination
Left atrioventricular outflow stenosis, prosthetic dysfunction due to preservation of valve apparatus
intra-operative trans-esophageal echo-cardiograph examination
Change in post-operative left ventricular functions
Zeitfenster: 5 days post-operatively and end of 6th and 12 months after surgery with Echo-Cardiograph
: Low Fractional Shortening < 28% , Ejection fraction < 40%,, increased left ventricular dimensions and volume
5 days post-operatively and end of 6th and 12 months after surgery with Echo-Cardiograph
Change of Prosthetic mitral valve functions
Zeitfenster: Monthly through study completion up to 12 months after surgery..... with Echo-cardiograph
Development of para-valvular leak or central jet of regurgitation or stuck valve by a thrombus
Monthly through study completion up to 12 months after surgery..... with Echo-cardiograph

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
changes on Clinical examination
Zeitfenster: Monthly up to 12 months after surgery)
local and general Examination,: a new murmur, evolving heart failure
Monthly up to 12 months after surgery)
Changes in Results of Prothrombin time, concentration and.International normalized ratio
Zeitfenster: .Monthly through study completion up to 12 months.
Adjust dose of oral anticoagulant.( between double and half to three times the control) Dose usually ranges between 1 and 11 mg warfarin tablet daily.
.Monthly through study completion up to 12 months.
Mortality and Morbidity
Zeitfenster: Monthly through study completion up to 12 months.
cause of mortality, type of morbidity: wound infection, hypertrophied scar, Kiloid Formation
Monthly through study completion up to 12 months.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Suez Canal University

Mitarbeiter

National Research Centre, Egypt

Ermittler

  • Studienleiter: Mohamed A. allaban, PhD, Suez Canal University, FOM- Research Ethics Committee

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

28. Dezember 2016

Primärer Abschluss (Tatsächlich)

1. Januar 2020

Studienabschluss (Tatsächlich)

28. Dezember 2021

Studienanmeldedaten

Zuerst eingereicht

1. Juni 2022

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

23. Juni 2022

Zuerst gepostet (Tatsächlich)

30. Juni 2022

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

30. Juni 2022

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

23. Juni 2022

Zuletzt verifiziert

1. Juni 2022

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2796#

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by H. D. Elayouty, H. S. Hassan and S.A. Elhafeez. The first draft of the manuscript was written by A. H.Elayouty and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

IPD-Sharing-Zeitrahmen

Within 360 days

IPD-Sharing-Zugriffskriterien

h.dosoky@yahoo.com

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ICF
  • CSR

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Ja

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Ja

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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