NCT05455788

Brief Summary

Follow-up of patients undergoing cardiac valve replacements with prosthetic valve after injection of sewing ring of prosthetic valve with aminoglycoside for prevention of infective endocarditis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

December 1, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 13, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
Last Updated

July 13, 2022

Status Verified

July 1, 2022

Enrollment Period

2 years

First QC Date

July 1, 2022

Last Update Submit

July 9, 2022

Conditions

Prosthetic Valve Endocarditis

Outcome Measures

Primary Outcomes (1)

  • number of patients diagnosed with Infective endocarditis post valve replacement

    percentage of post operative clinical and echocardiographic diagnosis of infective endocarditis on prosthetic valve

    6 months post operative

Study Arms (1)

Patients undergoing Cardiac valve replacement

Drug: Aminoglycoside

Interventions

AminoglycosideDRUG

injection of sewing ring of prosthetic valve with aminoglycoside

Patients undergoing Cardiac valve replacement

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients diagnosed with heart valve disease and indicated for valve replacement.

You may qualify if:

  • patients who need cardiac valve replacement for rheumatic or degenerative causes

You may not qualify if:

  • Patients undergoing open heart surgery for any cause other than valve replacement
  • patients who are younger than 20 years old.
  • Patients undergoing valve repair.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 21557, Egypt

RECRUITING

MeSH Terms

Interventions

Aminoglycosides

Intervention Hierarchy (Ancestors)

GlycosidesCarbohydrates

Central Study Contacts

Kareem A Hosny

CONTACT

01000401994kojakkemo@gmail.com

Amr I Osman

CONTACT

01000433878dr.amr-osman@outlook.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

July 1, 2022

First Posted

July 13, 2022

Study Start

December 1, 2021

Primary Completion

December 1, 2023

Study Completion

December 15, 2023

Last Updated

July 13, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)