Outcome of Preserved Mitral Valve Apparatus During Mitral Valve Replacement (EarlyOutcome)
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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Ismailia, 이집트, +064
- Suez Canal University
-
Ismailia, 이집트, 002-064
- Suez Canal University
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
가짜 비교기: Group A
50 patients with isolated rheumatic mitral valve disease (group A)
|
St.Jude prosthetic(FDA approved) mitral valve replacement with or without coronary artery bypass grafts
다른 이름들:
|
|
다른: Group B
50 patients with mitral disease and myocardial ischemia (group B)
|
St.Jude prosthetic(FDA approved) mitral valve replacement with or without coronary artery bypass grafts
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Smoking index
기간: 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
기간: 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
기간: 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
기간: Seven days before surgery .
|
Rheumatic: distorted thickened leaflets,thickened fibrosed chordae
|
Seven days before surgery .
|
|
For each participant: etiological :type of mitral valve lesion
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
changes on Clinical examination
기간: 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
기간: .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
기간: 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.
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Mohamed A. allaban, PhD, Suez Canal University, FOM- Research Ethics Committee
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2796#
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .