Anterior MINCT05285631
Early Prediction of ICD Candidacy After Anterior Myocardial Infarction
An observational study of Anterior MI, run by Aswan University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anterior MI
- What is being tested?
- Speckle tracking echocardiography (STE)
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 31 May 2022to 31 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting by acute anterior myocardial infarction, with baseline echocardiographic assessment demonstrating LVEF < 40%.
Who may be able to join
- 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.
Who cannot join
- ● 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Although the majority of deaths after acute MI occurs in the earlier weeks, however, causes of deaths were almost split between arrhythmic and non-arrhythmic deaths. In the large study conducted by Solomon et al., sudden cardiac death (SCD) was responsible for around 40% of the total mortality.Similarly, arrhythmic death counted for 52% and 49% of the total mortality encountered in the randomized control trial testing role of wearable cardioverter vest in the therapy and control groups respectively, where the remainder were non-arrhythmic (and thus considered non-preventable) deaths.Probably, this fact remains the main driver for the guidelines" writers to label implanting an ICD for primary prevention during the first 90 days after revascularization for MI as class III [contraindicated - no benefit].The large number of potentially preventable SCD triggered investigators to challenge the guidelines" recommendations. At least 3 large, randomized control trials (RCT) tested ICD implantation early prior establishing guidelines-recommended time range; 40 days after MI and/or 90 days after optimal therapy including revascularization.
In the DINAMIT RCT, recruiting 332 patients in the ICD arm vs. 342 in the control arm, ICD significantly reduced arrhythmic death (hazard ratio (HR) 0.42, 95% confidence interval (CI) 0.22 to 0.83;P=0.009). Yet, unfortunately, this benefit was mitigated by the increased non arrhythmic death in the ICD group.Likewise, in the IRIS multicenter RCT, 898 acute MI patients were recruited (445 in the ICD vs 453 in the control arm), ICD significantly reduced SCDs ((27 vs. 60; HR, 0.55; 95% CI, 0.31 to 1.00; P = 0.049)), however, overall mortality was similar between the 2 groups.The third and most recent RCT, "Defibrillator After Primary Angioplasty", the DAPA trial, was published late in 2020.10 Probably reflecting the recent advances in pharmacologic therapies for heart failure and reduced ejection fraction (HFrEF) in the past years, the DAPA trial at its early and long-term follow up reports found that ICD significantly reduced both arrhythmic and all-cause deaths when implanted early to selected patients after primary angioplasty.This unsettled argument between accelerated vs. delayed implantation of ICD for potential candidates after MI sparked for the VEST investigators to randomly assign post MI patients to either Wearable Cardioverter Defibrillator (WCD) plus medical therapy vs. medical therapy alone to test if the wearable device can effectively prevent SCDs during this high risk period.7 Nevertheless, compliance to the WCD was very poor. Despite instructions to wear the device for more than 90% of the time, 43 patients (around 3%) never wore the device and mean ± standard deviation of device wearing time was 14.0±9.3 hours per day, with decreasing use over time. Thus, 75% of the deaths in the device arm occurred while not wearing the vest with strong concerns that the majority of these could have been prevented.Overall, WCD could not effectively reduce death in patients with LVEF ≤ 35% early after MI in this study.Echocardiography has a critical impact on diagnostic and therapeutic decisions in the settings of acute MI. According to the current guidelines, echocardiography-derived LVEF after 90 days of revascularization remains the single most accepted determinant for ICD candidacy. However, there are many limitations in early predicting the LVEF value at the defined time.In the large study conducted by Brooks et al., recruiting patients reduced <35% LVEF acutely post MI with; it was shown at 90 days that only 43% had unchanged LVEF (<35%), while 31% and 26% of the patients have their EF recovered to 36-49% and > 50% respectively. This clearly demonstrates that more than half of the patients with baseline LVEF < 35% had improved at 90 days after revascularization to above the cut-off for ICD eligibility.Speckle tracking echocardiography (STE) have shown great value in improving accuracy of standard echocardiographic assessments.
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.18-20 Global longitudinal strain (GLS) assessed by STE has shown an incremental value beyond traditional echo parameters for risk stratification after AMI.The value of STE to early elicit myocardial structural and functional abnormalities have been shown in many conditions to be more sensitive that the traditional LVEF. This fact elected STE as an accepted sensitive marker to detect myocardial abnormalities before LVEF starts to deviate from normal values such as screening for chemotherapy induced cardiomyopathy.22 An additive role for STE to early identify patients with irreversible myocardial damage contrasted to those with transient/reversible systolic dysfunction can help in earlier patients stratification to receive timed appropriate therapies.Therefore, development of a stratification tool involving advanced imaging modalities besides clinical and laboratory variables that can be utilized to early identify patients eligible for ICD primary prevention therapy can be extremely beneficial to avoid many preventable cardiac deaths in the future.
- Conditions
- Anterior MI
- Being tested
- Speckle tracking echocardiography (STE)
- Medical subject headings
- Anterior Wall Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speckle tracking echocardiography (STE)Device
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90 days
Secondary outcomes (1)
ICD candidacy prediction scores
Development of prediction models for ICD candidacy that can be applied shortly after anterior MI integrating speckle tracking echo, demographic features and comorbidity indices.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start31 May 2022
- Primary completion31 Dec 2025
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior MIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aswan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taha Salah, Aswan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05285631
- Sponsor's protocol ID
- EPIC-Anterior-MI
- Status last verified
- Mar 2022
- First submitted
- 11 Feb 2022
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Prediction of ICD Candidacy After Anterior Myocardial Infarction
- ClinicalTrials.gov ID
- NCT05285631
- Acronym / sponsor ID
- EPIC-Anterior-MI
- Conditions
- Anterior MI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Aswan UniversityUniversity, hospital or other
- Study start
- 31 May 2022 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 17 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Although the majority of deaths after acute MI occurs in the earlier weeks, however, causes of deaths were almost split between arrhythmic and non-arrhythmic deaths. In the large study conducted by Solomon et al., sudden cardiac death (SCD) was responsible for around 40% of the total mortality.Similarly, arrhythmic death counted for 52% and 49% of the total mortality encountered in the randomized control trial testing role of wearable cardioverter vest in the therapy and control groups respectively, where the remainder were non-arrhythmic (and thus considered non-preventable) deaths.Probably, this fact remains the main driver for the guidelines" writers to label implanting an ICD for primary prevention during the first 90 days after revascularization for MI as class III [contraindicated - no benefit].The large number of potentially preventable SCD triggered investigators to challenge the guidelines" recommendations. At least 3 large, randomized control trials (RCT) tested ICD implantation early prior establishing guidelines-recommended time range; 40 days after MI and/or 90 days after optimal therapy including revascularization.
In the DINAMIT RCT, recruiting 332 patients in the ICD arm vs. 342 in the control arm, ICD significantly reduced arrhythmic death (hazard ratio (HR) 0.42, 95% confidence interval (CI) 0.22 to 0.83;P=0.009). Yet, unfortunately, this benefit was mitigated by the increased non arrhythmic death in the ICD group.Likewise, in the IRIS multicenter RCT, 898 acute MI patients were recruited (445 in the ICD vs 453 in the control arm), ICD significantly reduced SCDs ((27 vs. 60; HR, 0.55; 95% CI, 0.31 to 1.00; P = 0.049)), however, overall mortality was similar between the 2 groups.The third and most recent RCT, "Defibrillator After Primary Angioplasty", the DAPA trial, was published late in 2020.10 Probably reflecting the recent advances in pharmacologic therapies for heart failure and reduced ejection fraction (HFrEF) in the past years, the DAPA trial at its early and long-term follow up reports found that ICD significantly reduced both arrhythmic and all-cause deaths when implanted early to selected patients after primary angioplasty.This unsettled argument between accelerated vs. delayed implantation of ICD for potential candidates after MI sparked for the VEST investigators to randomly assign post MI patients to either Wearable Cardioverter Defibrillator (WCD) plus medical therapy vs. medical therapy alone to test if the wearable device can effectively prevent SCDs during this high risk period.7 Nevertheless, compliance to the WCD was very poor. Despite instructions to wear the device for more than 90% of the time, 43 patients (around 3%) never wore the device and mean ± standard deviation of device wearing time was 14.0±9.3 hours per day, with decreasing use over time. Thus, 75% of the deaths in the device arm occurred while not wearing the vest with strong concerns that the majority of these could have been prevented.Overall, WCD could not effectively reduce death in patients with LVEF ≤ 35% early after MI in this study.Echocardiography has a critical impact on diagnostic and therapeutic decisions in the settings of acute MI. According to the current guidelines, echocardiography-derived LVEF after 90 days of revascularization remains the single most accepted determinant for ICD candidacy. However, there are many limitations in early predicting the LVEF value at the defined time.In the large study conducted by Brooks et al., recruiting patients reduced <35% LVEF acutely post MI with; it was shown at 90 days that only 43% had unchanged LVEF (<35%), while 31% and 26% of the patients have their EF recovered to 36-49% and > 50% respectively. This clearly demonstrates that more than half of the patients with baseline LVEF < 35% had improved at 90 days after revascularization to above the cut-off for ICD eligibility.Speckle tracking echocardiography (STE) have shown great value in improving accuracy of standard echocardiographic assessments.
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.18-20 Global longitudinal strain (GLS) assessed by STE has shown an incremental value beyond traditional echo parameters for risk stratification after AMI.The value of STE to early elicit myocardial structural and functional abnormalities have been shown in many conditions to be more sensitive that the traditional LVEF. This fact elected STE as an accepted sensitive marker to detect myocardial abnormalities before LVEF starts to deviate from normal values such as screening for chemotherapy induced cardiomyopathy.22 An additive role for STE to early identify patients with irreversible myocardial damage contrasted to those with transient/reversible systolic dysfunction can help in earlier patients stratification to receive timed appropriate therapies.Therefore, development of a stratification tool involving advanced imaging modalities besides clinical and laboratory variables that can be utilized to early identify patients eligible for ICD primary prevention therapy can be extremely beneficial to avoid many preventable cardiac deaths in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting by acute anterior myocardial infarction, with baseline echocardiographic assessment demonstrating LVEF < 40%.
Key inclusion criteria (3 listed)
- Age between 18 and 80 years. Both genders are eligible.
Key exclusion criteria (8 listed)
- ● Refusal to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Speckle tracking echocardiography (STE)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. | Device | – |
Primary outcome
Early prediction of ICD candidacy in anterior STEMI patients by speckle tracking echocardiography
Time frame: 90 days
Early prediction of ICD candidacy (EF < 35% after 90 days) by speckle tracking echo performed at baseline and at 30 days
1 secondary outcome
ICD candidacy prediction scores
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior MI, run by Aswan University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early prediction of ICD candidacy in anterior STEMI patients by speckle tracking echocardiography (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.