NCT04106648

Brief Summary

The goal of the study is to correlate the effect of ischemic mitral regurgitation on the outcome of STEMI patients treated with successful primary PCI using clinical data and echocardiography on presentation and during short term follow up after 3 months

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
134

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2020

Typical duration for all trials

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

September 25, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2019

Completed
1.1 years until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2023

Completed
Last Updated

January 22, 2020

Status Verified

January 1, 2020

Enrollment Period

1.9 years

First QC Date

September 25, 2019

Last Update Submit

January 17, 2020

Conditions

Ischemic Mitral Regurgitation

Keywords

Ischemic Mitral Regurgitationprimary percutaneous coronary interventionSTEMI

Outcome Measures

Primary Outcomes (1)

  • effect of ischemic mitral regurgitation on the outcome of STEMI patients treated with successful primary PCI

    clinical data and echocardiography

    3 months

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with STEMI undergoing PPCI

You may qualify if:

  • Subjects with first presentation
  • Subjects with Acute STEMI
  • Subjects undergoing Primary PCI with Successful reperfusion
  • Subjects with significant IMR Grade (III/IV) to (IV/IV)
  • Subjects with acute STEMI with no or non-significant MR undergoing Primary PCI undergoing primary PCI with successful reperfusion (as control)

You may not qualify if:

  • Rheumatic mitral regurge
  • Valvular mitral regurge
  • IMR Grade (II/IV)
  • Cardiomyopathies
  • Associated other valvular heart diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Fady Usama Kostandy, Msc

    Assiut University

    PRINCIPAL INVESTIGATOR

  • Hatem Abd El Rahman, Professor

    Assiut University

    STUDY DIRECTOR

  • Magdy Ibrahim Eldesowky, Lecturer

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Fady Usama Kostandy, Msc

CONTACT

1277895809f.usama.kostandy@gmail.com

Study Design

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

Study Record Dates

First Submitted

September 25, 2019

First Posted

September 27, 2019

Study Start

November 1, 2020

Primary Completion

September 20, 2022

Study Completion

September 20, 2023

Last Updated

January 22, 2020

Record last verified: 2020-01