NCT04103008

Brief Summary

Recovery of the left ventricular function is variable from one patient to another, thus assessment of cardiac function by measuring left ventricular ejection fraction using echocardiography is the most common in the daily clinical practice. However, this technique has limitation related with its intra- and interobserver variability. A recent technique, 2D speckle tracking for assessing global longitudinal strain, has been introduced to reduce the variability and potentially has a higher accuracy. Speckle tracking is a method which uses two dimensions recording for measuring quantity of movement of myocardium in several segments. Speckle-tracking echocardiography is a current noninvasive ultrasound imaging technique that allows for an objective and quantitative evaluation of global and regional myocardial function independently from the angle of insonation and from cardiac translational movements,

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2019

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

First Submitted

Initial submission to the registry

September 21, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

September 25, 2019

Status Verified

September 1, 2019

Enrollment Period

10 months

First QC Date

September 21, 2019

Last Update Submit

September 23, 2019

Conditions

Myocardial InfarctionEchocardiography 2DLeft Ventricular Dysfunction

Keywords

Speckle tracking2D echocardiographyLeft ventricle residual functionPCI, percutaneous coronary interventionsingle coronary arterymultiple coronary arteries

Outcome Measures

Primary Outcomes (1)

  • Assessing change of left ventricular function

    measure ejection fraction

    baseline and after 40 days of PCI

Secondary Outcomes (1)

  • Major adverse cardiovascular events

    40 days

Study Arms (2)

Group A

single coronary artery lesion

Diagnostic Test: Speckle tracking echocardiography

Group B

multiple coronary artery lesions

Diagnostic Test: Speckle tracking echocardiography

Interventions

Speckle tracking echocardiographyDIAGNOSTIC_TEST

assess left ventricular function on admission and after 40 days

Also known as: 2 D echocardiography
Group AGroup B

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with acute myocardial infarction with single or multiple coronary artery lesions seen after PCI on admission and after 40 days

You may qualify if:

  • Patients with acute myocardial infarction eligible for PCI seen on admission and after 40 days

You may not qualify if:

  • cardiomyopathy
  • cancer
  • on cytostatic treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospitals

Asyut, 71515, Egypt

Location

Related Publications (1)

  • Abdelhafez MA, Aly KME, Youssef AAA. Effect of residual myocardial ischemia on recovery of left ventricular function after primary percutaneous coronary intervention. BMC Cardiovasc Disord. 2024 Mar 19;24(1):164. doi: 10.1186/s12872-024-03777-3.

    PMID: 38504186DERIVED

MeSH Terms

Conditions

Myocardial InfarctionVentricular Dysfunction, Left

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisVentricular Dysfunction

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Officials

  • Amr A Youssef, MD

    Professor of Cardiology

    STUDY CHAIR

  • Mohamed A Abdel Hafez, MD

    Associate Professor

    STUDY DIRECTOR

Central Study Contacts

Karim ME Aly

CONTACT

01068545195karimeltaher294@gmail.com

Aliae AR Mohamed-Hussein, MD

CONTACT

01222302352aliaehussein@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of Cardiology

Study Record Dates

First Submitted

September 21, 2019

First Posted

September 25, 2019

Study Start

November 1, 2019

Primary Completion

September 1, 2020

Study Completion

December 1, 2020

Last Updated

September 25, 2019

Record last verified: 2019-09

Locations

EG(1)