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

23 juni 2022 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

100

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

30 jaar tot 65 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Sham-vergelijker: Group A
50 patients with isolated rheumatic mitral valve disease (group A)
Apparaat: 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
Ander: Group B
50 patients with mitral disease and myocardial ischemia (group B)
Apparaat: 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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Smoking index
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Seven days before surgery .
Rheumatic: distorted thickened leaflets,thickened fibrosed chordae
Seven days before surgery .
For each participant: etiological :type of mitral valve lesion
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
changes on Clinical examination
Tijdsspanne: 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
Tijdsspanne: .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
Tijdsspanne: 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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Suez Canal University

Medewerkers

National Research Centre, Egypt

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

28 december 2016

Primaire voltooiing (Werkelijk)

1 januari 2020

Studie voltooiing (Werkelijk)

28 december 2021

Studieregistratiedata

Eerst ingediend

1 juni 2022

Eerst ingediend dat voldeed aan de QC-criteria

23 juni 2022

Eerst geplaatst (Werkelijk)

30 juni 2022

Updates van studierecords

Laatste update geplaatst (Werkelijk)

30 juni 2022

Laatste update ingediend die voldeed aan QC-criteria

23 juni 2022

Laatst geverifieerd

1 juni 2022

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2796#

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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-tijdsbestek voor delen

Within 360 days

IPD-toegangscriteria voor delen

h.dosoky@yahoo.com

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF
  • MVO

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

product vervaardigd in en geëxporteerd uit de V.S.

Ja

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