Myocardial Work for Prediction of Left Ventricular Remodeling in Patients With STEMI

October 24, 2021 updated by: RenJi Hospital

Value of Myocardial Work for Prediction of Left Ventricular Remodeling in Patients With ST-Elevation Myocardial Infarction Treated by Primary Percutaneous Intervention

The study intends to investigate the alteration of regional myocardial work in patients with acute anterior myocardial infarction underwent primary percutaneous coronary intervention (PCI), and compare the distribution of regional myocardial work in patients with/without early remodeling at acute phase and 3-month follow-up.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

98

Contacts and Locations

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

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200125
        • Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with anterior STEMI who underwent primary PCI <12 hours after symptom onset were consecutive enrolled in our center.

Description

Inclusion Criteria:

  • Anterior myocardial infarct (anterior myocardial infarct is defined as persistent chest pain for 30 mins at least, with ST-segment elevation of at least 0.2 mV in two or more contiguous precordial leads) within 12 hours after onsets of symptom;
  • Left anterior descending (LAD) as culprit vessel, with TIMI 0-1 grade.

Exclusion Criteria:

  • significant valvular disease;
  • cardiomyopathy; l
  • left bundle branch block;
  • atrial fibrillation;
  • previous myocardial infarction (MI);
  • history of cardiac surgery;
  • pacemaker implantation.

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
patients with LVR(left ventricular remodeling)
patients without LVR(left ventricular remodeling)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delta-work efficiency by echocardiography
Time Frame: 24-72 hours after PCI
A novel tool for non-invasive myocardial work(MW) assessment has been introduced to evaluate myocardial performance.MW was calculated as a function of time through a combination of LV global longitudinal strain(GLS) data and an estimated LV pressure curves. Work efficiency (WE) was calculated from the ratio of the constructive work to the sum of constructive and wasted work, expressed as a percentage.The values of culprit regional WE was expressed as WE-LAD.The values of non-culprit regional WE was expressed as WE-nonLAD.The absolute differences of the WE was calculated as the values of non-culprit regional WE minus the values of culprit regional WE, and noted as delta-WE.
24-72 hours after PCI

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global work index by echocardiography
Time Frame: 24-72 hours, 3-month after PCI
Global work index (GWI) is classified as total work within the area of the LV pressure-strain loop calculated from mitral valve closure to mitral valve opening.
24-72 hours, 3-month after PCI
Global constructive work by echocardiography
Time Frame: 24-72 hours, 3-month after PCI
Global constructive work (GCW) was defined as work contributing to LV ejection performed during shortening in systole and work performed during lengthening in isovolumic relaxation.
24-72 hours, 3-month after PCI
Global work efficiency by echocardiography
Time Frame: 24-72 hours, 3-month after PCI
Global work efficiency (GWE) was calculated from the ratio of the constructive work to the sum of constructive and wasted work, expressed as a percentage.
24-72 hours, 3-month after PCI
Work index-LAD
Time Frame: 24-72 hours, 3-month after PCI
Work index in left anterior descending(LAD) territory.
24-72 hours, 3-month after PCI
Constructive work-LAD
Time Frame: 24-72 hours, 3-month after PCI
constructive work in left anterior descending(LAD) territory.
24-72 hours, 3-month after PCI
Work efficiency-LAD
Time Frame: 24-72 hours, 3-month after PCI
Work efficiency in left anterior descending(LAD) territory.
24-72 hours, 3-month after PCI

Collaborators and Investigators

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

Sponsor

RenJi Hospital

Investigators

  • Principal Investigator: Song Ding, MD,PHD, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

September 10, 2019

Primary Completion (Actual)

May 24, 2021

Study Completion (Actual)

August 30, 2021

Study Registration Dates

First Submitted

October 24, 2021

First Submitted That Met QC Criteria

October 24, 2021

First Posted (Actual)

November 4, 2021

Study Record Updates

Last Update Posted (Actual)

November 4, 2021

Last Update Submitted That Met QC Criteria

October 24, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STEMI-myocardial work

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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