NCT04439162

Brief Summary

During coronary artery bypass surgery, myocardial protection, especially of the right ventricle, may be inadequate in the presence of severe coronary lesions that obstruct the antegrade delivery of cold cardioplegia

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2020

Status
unknown

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

First Submitted

Initial submission to the registry

June 11, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 19, 2020

Completed
12 days until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

June 19, 2020

Status Verified

June 1, 2020

Enrollment Period

11 months

First QC Date

June 11, 2020

Last Update Submit

June 17, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • myocardial function

    compare simultaneous antegrade-retrograde cardioplegia with antegrade cardioplegia in coronary artery surgeries in preservation of myocardial function by using transthoracic echocardiography examination postoperatively

    two years

Study Arms (1)

group A

EXPERIMENTAL

antegrade cardioplegia

Procedure: retrograde cardioplegia protection

Interventions

antegrade-retrograde cardioplegia

group A

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 and 60 years
  • LV ejection fraction between 30 and 50%
  • left main stem CAD
  • mitral or aortic valve disease associated with ischemic heart disease

You may not qualify if:

  • Double valve disease or other valve disease
  • mitral or aortic valve disease associated with congenital heart disease
  • patients subjected to prior heart surgery
  • emergency operation
  • poorly controlled diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Elhussein M abdelmottaleb, Ph.D

CONTACT

ahmed m abdelmottaleb, lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: RCT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate lecteuer

Study Record Dates

First Submitted

June 11, 2020

First Posted

June 19, 2020

Study Start

July 1, 2020

Primary Completion

June 1, 2021

Study Completion

April 1, 2022

Last Updated

June 19, 2020

Record last verified: 2020-06