NCT04228510

Brief Summary

ST-segment elevation myocardial infarction (STEMI) is a major cause of morbidity and mortality worldwide. In spite of decrease in acute and long-term mortality following STEMI in parallel with more use of reperfusion therapy, such as primary percutaneous coronary intervention (PPCI), modern antithrombotic therapy, and secondary prevention, mortality remains considerable. Reduced EF is a well-known predictor of increased short and long term major adverse cardiovascular events MACE :( heart failure, stroke and death)

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
204

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 14, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

January 14, 2020

Status Verified

January 1, 2020

Enrollment Period

1.5 years

First QC Date

January 12, 2020

Last Update Submit

January 12, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • The Incidence of major adverse cardiovascular events

    the rate of Acute coronary syndrome, Heart failure, Stroke and all-cause mortality

    1 year

Study Arms (1)

Study group

ST elevation myocardial infarction (STEMI) patients after primary percutaneous coronary intervention who will be followed up in Assiut University hospital.

Procedure: 2D speckle tracking echocardiography

Interventions

Global and segmental strain and strain rate in longitudinal and circumferential directions will be detected after PPCI; before discharge. The LV circumferential strains and strain rates will be determined from the short-axis views at the basal, middle, and apical levels, and longitudinal strains and strain rates will be determined from the apical 2-, 3-, and 4-chamber views of the LV. Segmental longitudinal strains equal to -15% or closer to 0 will be considered abnormal (injured segments). The average segmental longitudinal strain and strain rate of the abnormal segments is defined as the injury longitudinal strain (InjLS) and injury longitudinal systolic strain rate (InjLSRs).

Study group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

ST elevation myocardial infarction patients after primary percutaneous coronary intervention who will be followed up for a one year in Assiut University hospital.

You may qualify if:

  • ST elevation myocardial infarction patients after primary percutaneous coronary intervention

You may not qualify if:

  • Previous myocardial infarction.
  • Sever or haemodynamically significant (associated with chamber dilation) valvular heart diseases.
  • Previous heart failure.
  • Previous cerebrovascular strokes.
  • Atrial fibrillation.
  • Severe comorbidities as severe renal impairment, hepatic or respiratory failure.
  • Bad equality views which affects accurate speckle tracking imaging.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Hatem Helmy, MD

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Aly Tohamy, MD

CONTACT

Ayman Khairy, MD

CONTACT

Study Design

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

Study Record Dates

First Submitted

January 12, 2020

First Posted

January 14, 2020

Study Start

March 1, 2020

Primary Completion

September 1, 2021

Study Completion

December 1, 2021

Last Updated

January 14, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share