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

23. juni 2022 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

100

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

30 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Sham-komparator: Group A
50 patients with isolated rheumatic mitral valve disease (group A)
Enhed: 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
Andre navne:
  • 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
Andet: Group B
50 patients with mitral disease and myocardial ischemia (group B)
Enhed: 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
Andre navne:
  • 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Smoking index
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Seven days before surgery .
Rheumatic: distorted thickened leaflets,thickened fibrosed chordae
Seven days before surgery .
For each participant: etiological :type of mitral valve lesion
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
changes on Clinical examination
Tidsramme: 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
Tidsramme: .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
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Suez Canal University

Samarbejdspartnere

National Research Centre, Egypt

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

28. december 2016

Primær færdiggørelse (Faktiske)

1. januar 2020

Studieafslutning (Faktiske)

28. december 2021

Datoer for studieregistrering

Først indsendt

1. juni 2022

Først indsendt, der opfyldte QC-kriterier

23. juni 2022

Først opslået (Faktiske)

30. juni 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. juni 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. juni 2022

Sidst verificeret

1. juni 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2796#

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

Within 360 days

IPD-delingsadgangskriterier

h.dosoky@yahoo.com

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ja

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