NCT05797090

Brief Summary

Mitral valvuloplasty for correction of chronic mitral regurgitation carries a lower operative mortality and morbidity and improved long-term survival than does mitral valve replacement. Unfortunately, mitral valvuloplasty is not possible in all patients with chronic mitral regurgitation because of unfavorable pathology or lack of experience with this technique

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2023

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 4, 2023

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

8 months

First QC Date

February 25, 2023

Last Update Submit

May 3, 2023

Conditions

Mitral Valve Surgery

Outcome Measures

Primary Outcomes (1)

  • myocardial protection

    Number of Participants With myocardial protection through measurements of the serum levels of the cardiac enzymes just after operation

    from baseline to 24 hours after the operation

Study Arms (1)

crystalloid cardioplegia with modified del Nido cardioplegia

EXPERIMENTAL

To compare between conventional crystalloid cardioplegia with modified del Nido cardioplegia in mitral valve regurge replacement surgery.

Drug: Crystalloid Cardioplegic solution

Interventions

Crystalloid Cardioplegic solutionDRUG

To compare between conventional crystalloid cardioplegia with modified del Nido cardioplegia in mitral valve regurge replacement surgery.

Also known as: Modified Del Nido Cardioplegia
crystalloid cardioplegia with modified del Nido cardioplegia

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- Patients scheduled for elective Mitral regurge replacement Surgery with normal Coronaries

You may not qualify if:

  • Patients with chronic renal disease (previous medical diagnosis or serum creatinine greater than 1.5mg/dL)
  • Left ventricular ejection fraction less than 50%.
  • Previous cardiac surgery
  • Patient with BMI \> 30
  • Severe psychiatric illness
  • Inability or unwillingness to give informed consent for participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azhar University

Cairo, 11765, Egypt

Location

MeSH Terms

Interventions

potassium cardioplegic solution

Study Officials

  • Mohamed Abdel-Gawad, Lecturer

    Faculty of Medicine - Al-Azhar University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer of Anesthesia, intensive care and pain management Faculty of Medicine - Al-Azhar University

Study Record Dates

First Submitted

February 25, 2023

First Posted

April 4, 2023

Study Start

July 1, 2022

Primary Completion

March 1, 2023

Study Completion

March 15, 2023

Last Updated

May 6, 2023

Record last verified: 2023-05

Locations

EG(1)