Two- Dimensional Speckle Tracking Echocardiography After Primary Percutaneous Coronary Intervention

January 12, 2020 updated by: Waleed Rafat Rasmy, Assiut University

The Role of Two- Dimensional Speckle Tracking Echocardiography in Prediction of Remodeling and Major Adverse Cardiovascular Events in ST Elevation Myocardial Infarction After Primary Percutaneous Coronary Intervention

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)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

204

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability 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.

Description

Inclusion Criteria:

  • ST elevation myocardial infarction patients after primary percutaneous coronary intervention

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Incidence of major adverse cardiovascular events
Time Frame: 1 year
the rate of Acute coronary syndrome, Heart failure, Stroke and all-cause mortality
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Hatem Helmy, MD, Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2020

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

January 12, 2020

First Submitted That Met QC Criteria

January 12, 2020

First Posted (Actual)

January 14, 2020

Study Record Updates

Last Update Posted (Actual)

January 14, 2020

Last Update Submitted That Met QC Criteria

January 12, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2DSE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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