Early Prediction of ICD Candidacy After Anterior Myocardial Infarction
1 other identifier
observational
400
0 countries
N/A
Brief Summary
Despite the advances of pharmacologic and interventional therapies, sudden (or arrhythmic) cardiac death remains very high in the early weeks-to-months after an acute myocardial infarction (MI).The majority of cardiac arrests occur in patients who have large infarctions resulting in extensive myocardial damage, which is translated into lower left ventricular ejection fraction (LVEF). Hence, low LVEF remains -to the current time- the most robust predictor for post MI sudden (and presumably arrhythmic) death; and is the determinant for implantable cardioverter defibrillator (ICD) candidacy for primary prevention as per clinical practice guidelines.ICD significantly and effectively reduced ventricular arrhythmia (VA)-mediated cardiac deaths among these patients.
Trial Health
Trial Health Score
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participants targeted
Target at P75+ for all trials
Started May 2022
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2022
CompletedFirst Posted
Study publicly available on registry
March 17, 2022
CompletedStudy Start
First participant enrolled
May 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2024
CompletedMarch 17, 2022
March 1, 2022
1.6 years
February 11, 2022
March 14, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Early prediction of ICD candidacy in anterior STEMI patients by speckle tracking echocardiography
Early prediction of ICD candidacy (EF \< 35% after 90 days) by speckle tracking echo performed at baseline and at 30 days
90 days
Secondary Outcomes (1)
ICD candidacy prediction scores
90 days
Interventions
Two-dimensional (2D) and 3D STE are based on the quantitative analysis of spatial dislocation (tracking) of acoustic markers (""speckles"") generated by the interaction between the ultrasound beam and myocardial fibers during the cardiac cycle.
Eligibility Criteria
Patients presenting by acute anterior myocardial infarction, with baseline echocardiographic assessment demonstrating LVEF \< 40%.
You may qualify if:
- Age between 18 and 80 years. Both genders are eligible.
- Patients with diagnosis of an acute anterior STEMI and revascularized with successful primary percutaneous coronary intervention (PCI) within 24 hours.
- LVEF \< 40 % assessed by Bi-plane Simpsons rule within 48 hour post PCI.
You may not qualify if:
- ● Refusal to participate in the study.
- Patients with existing ICD or pacemakers.
- Qualifying ICD for secondary prevention.
- Known to have LVEF ≤ 40% prior to the index MI.
- Previous PCI to Left anterior Descending artery (LAD).
- Previous or being scheduled for CABG within ≤ 3 months.
- Known to have limited life expectancy (less than 1-year) prior to the index MI.
- Pregnant or lactating women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aswan Universitylead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 11, 2022
First Posted
March 17, 2022
Study Start
May 1, 2022
Primary Completion
December 1, 2023
Study Completion
March 1, 2024
Last Updated
March 17, 2022
Record last verified: 2022-03