NCT05107102

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 10, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 4, 2021

Completed
Last Updated

November 4, 2021

Status Verified

October 1, 2021

Enrollment Period

1.7 years

First QC Date

October 24, 2021

Last Update Submit

October 24, 2021

Conditions

Keywords

ST-segment elevated myocardial infarctionmyocardial workleft ventricular remodeling

Outcome Measures

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.

    24-72 hours after PCI

Secondary Outcomes (6)

  • Global work index by echocardiography

    24-72 hours, 3-month after PCI

  • Global constructive work by echocardiography

    24-72 hours, 3-month after PCI

  • Global work efficiency by echocardiography

    24-72 hours, 3-month after PCI

  • Work index-LAD

    24-72 hours, 3-month after PCI

  • Constructive work-LAD

    24-72 hours, 3-month after PCI

  • +1 more secondary outcomes

Study Arms (2)

patients with LVR(left ventricular remodeling)

patients without LVR(left ventricular remodeling)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200125, China

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Ventricular Remodeling

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Song Ding, MD,PHD

    Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2021

First Posted

November 4, 2021

Study Start

September 10, 2019

Primary Completion

May 24, 2021

Study Completion

August 30, 2021

Last Updated

November 4, 2021

Record last verified: 2021-10

Locations