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CompletedNCT05107102Updated Nov 4, 2021

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

An observational study in ST-Segment Elevated Myocardial Infarction, sponsored by RenJi Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-11-04.

Sponsored by RenJi Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
98
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • ST-Segment Elevated Myocardial Infarction

Keywords

  • ST-segment elevated myocardial infarction
  • myocardial work
  • left ventricular remodeling
03

In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's enrollment of 98 is below the median of 500 across 983 observational studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

RenJi Hospital is the lead sponsor of 535 studies on the registry; 244 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

Exclusion Criteria:

  • significant valvular disease;
  • cardiomyopathy; l
  • left bundle branch block;
  • atrial fibrillation;
  • previous myocardial infarction (MI);
  • history of cardiac surgery;
  • pacemaker implantation.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
98 participants (actual)
Patient registry
No

Groups and cohorts

  • patients with LVR(left ventricular remodeling)
  • patients without LVR(left ventricular remodeling)
06

What researchers measure

Primary outcomes

  1. Delta-work efficiency by echocardiography

    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.

    Time frame: 24-72 hours after PCI

Secondary outcomes

  1. Global work index by echocardiography

    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.

    Time frame: 24-72 hours, 3-month after PCI

  2. Global constructive work by echocardiography

    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.

    Time frame: 24-72 hours, 3-month after PCI

  3. Global work efficiency by echocardiography

    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.

    Time frame: 24-72 hours, 3-month after PCI

  4. Work index-LAD

    Work index in left anterior descending(LAD) territory.

    Time frame: 24-72 hours, 3-month after PCI

  5. Constructive work-LAD

    constructive work in left anterior descending(LAD) territory.

    Time frame: 24-72 hours, 3-month after PCI

  6. Work efficiency-LAD

    Work efficiency in left anterior descending(LAD) territory.

    Time frame: 24-72 hours, 3-month after PCI

07

Study locations

1 site
  • Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
    Shanghai, Shanghai 200125, China
08

References and documents

Publications

  • Wang W, Zhao H, Wan F, Shen XD, Ding S, Pu J. Inhomogeneous Distribution of Regional Myocardial Work Efficiency Predicts Early Left Ventricular Remodeling After Acute Anterior Myocardial Infarction Treated With Primary Percutaneous Intervention. Front Cardiovasc Med. 2022 Jul 27;9:922567. doi: 10.3389/fcvm.2022.922567. eCollection 2022. PubMed 35966524 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 4, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05107102
Lead sponsor
RenJi Hospital
Responsible party
Sponsor
First posted
Nov 4, 2021
Start date
Sep 10, 2019
Primary completion
May 24, 2021
Completion
Aug 30, 2021
Last update
Nov 4, 2021

Study contacts

Song Ding, MD,PHD
principal investigator · Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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