Myocardial InfarctionNCT04228510
Two- Dimensional Speckle Tracking Echocardiography After Primary Percutaneous Coronary Intervention
An observational study of Myocardial Infarction, run by Assiut University.
Trial summary
ST-segment elevation myocardial infarction (STEMI) is a major cause of morbidity and mortality worldwide. In spite of decrease in acute and long-term mortality following STEMI in parallel with more use of reperfusion therapy, such as primary percutaneous coronary intervention (PPCI), modern antithrombotic therapy, and… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- 2D speckle tracking echocardiography
- Type of treatment
- Surgery or procedure
- How many people
- 204 participants
- Where
- No sites listed yet
- Study dates
- Mar 2020to Dec 2021
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ST elevation myocardial infarction patients after primary percutaneous coronary intervention who will be followed up for a one year in Assiut University hospital.
Who may be able to join
- ST elevation myocardial infarction patients after primary percutaneous coronary intervention
Who cannot join
- Previous myocardial infarction.
- Sever or haemodynamically significant (associated with chamber dilation) valvular heart diseases.
- Previous heart failure.
- Previous cerebrovascular strokes.
- Atrial fibrillation.
- Severe comorbidities as severe renal impairment, hepatic or respiratory failure.
- Bad equality views which affects accurate speckle tracking imaging.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Role of Two- Dimensional Speckle Tracking Echocardiography in Prediction of Remodeling and Major Adverse Cardiovascular Events in ST Elevation Myocardial Infarction After Primary Percutaneous Coronary Intervention
ST-segment elevation myocardial infarction (STEMI) is a major cause of morbidity and mortality worldwide. In spite of decrease in acute and long-term mortality following STEMI in parallel with more use of reperfusion therapy, such as primary percutaneous coronary intervention (PPCI), modern antithrombotic therapy, and secondary prevention, mortality remains considerable. Reduced EF is a well-known predictor of increased short and long term major adverse cardiovascular events MACE :( heart failure, stroke and death)
- Conditions
- Myocardial Infarction
- Being tested
- 2D speckle tracking echocardiography
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2D speckle tracking echocardiographyProcedure or surgery
Global and segmental strain and strain rate in longitudinal and circumferential directions will be detected after PPCI; before discharge. The LV circumferential strains and strain rates will be determined from the short-axis views at the basal, middle, and apical levels, and longitudinal strains and strain rates will be determined from the apical 2-, 3-, and 4-chamber views of the LV.
Segmental longitudinal strains equal to -15% or closer to 0 will be considered abnormal (injured segments). The average segmental longitudinal strain and strain rate of the abnormal segments is defined as the injury longitudinal strain (InjLS) and injury longitudinal systolic strain rate (InjLSRs).
| Study group | Role | What they receive |
|---|---|---|
| Study group | ST elevation myocardial infarction (STEMI) patients after primary percutaneous coronary intervention who will be followed up in Assiut University hospital. Receives: Procedure: 2D speckle tracking echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Incidence of major adverse cardiovascular events
the rate of Acute coronary syndrome, Heart failure, Stroke and all-cause mortality
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study startMar 2020 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waleed Rafat Rasmy, Assiut University
- Investigators
- Hatem Helmy, MD, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04228510
- Sponsor's protocol ID
- 2DSE
- Status last verified
- Jan 2020
- First submitted
- 12 Jan 2020
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Two- Dimensional Speckle Tracking Echocardiography in Prediction of Remodeling and Major Adverse Cardiovascular Events in ST Elevation Myocardial Infarction After Primary Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT04228510
- Acronym / sponsor ID
- 2DSE
- Conditions
- Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2020 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 14 Jan 2020 (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.
ST-segment elevation myocardial infarction (STEMI) is a major cause of morbidity and mortality worldwide. In spite of decrease in acute and long-term mortality following STEMI in parallel with more use of reperfusion therapy, such as primary percutaneous coronary intervention (PPCI), modern antithrombotic therapy, and secondary prevention, mortality remains considerable. Reduced EF is a well-known predictor of increased short and long term major adverse cardiovascular events MACE :( heart failure, stroke and death)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Procedure: 2D speckle tracking echocardiographyST elevation myocardial infarction (STEMI) patients after primary percutaneous coronary intervention who will be followed up in Assiut University hospital. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ST elevation myocardial infarction patients after primary percutaneous coronary intervention who will be followed up for a one year in Assiut University hospital.
Key inclusion criteria (1 listed)
- ST elevation myocardial infarction patients after primary percutaneous coronary intervention
Key exclusion criteria (7 listed)
- Previous myocardial infarction.
- Sever or haemodynamically significant (associated with chamber dilation) valvular heart diseases.
- Previous heart failure.
- Previous cerebrovascular strokes.
- Atrial fibrillation.
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 |
|---|---|---|
| 2D speckle tracking echocardiographyGlobal and segmental strain and strain rate in longitudinal and circumferential directions will be detected after PPCI; before discharge. The LV circumferential strains and strain rates will be determined from the short-axis views at the basal, middle, and apical levels, and longitudinal strains and strain rates will be determined from the apical 2-, 3-, and 4-chamber views of the LV. Segmental longitudinal strains equal to -15% or closer to 0 will be considered abnormal (injured segments). The average segmental longitudinal strain and strain rate of the abnormal segments is defined as the injury longitudinal strain (InjLS) and injury longitudinal systolic strain rate (InjLSRs). | Procedure or surgery | Study group |
Primary outcome
The Incidence of major adverse cardiovascular events
Time frame: 1 year
the rate of Acute coronary syndrome, Heart failure, Stroke and all-cause mortality
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Hatem Helmy, MD study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction, run by Assiut University.
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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aly Tohamy, MD (01006258877, Ali.tohamy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Incidence of major adverse cardiovascular events (time frame: 1 year). 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 14 Jan 2020.