Myocardial InfarctionNCT04103008
Left Ventricular Function After Primary Percutaneous Coronary Intervention: Role of Speckle Echocardiography
An observational study of Myocardial Infarction and Echocardiography 2D, run by Assiut University at 1 site in Egypt.
Trial summary
Recovery of the left ventricular function is variable from one patient to another, thus assessment of cardiac function by measuring left ventricular ejection fraction using echocardiography is the most common in the daily clinical practice. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myocardial Infarction, Echocardiography 2D, Left Ventricular Dysfunction
- What is being tested?
- Speckle tracking echocardiography
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2019to 1 Dec 2020
- 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
- Adult, Older adult
Study population: Patients with acute myocardial infarction with single or multiple coronary artery lesions seen after PCI on admission and after 40 days
Who may be able to join
- Patients with acute myocardial infarction eligible for PCI seen on admission and after 40 days
Who cannot join
- cardiomyopathy
- cancer
- on cytostatic treatment.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Assiut University Hospitals
Asyut, 71515
Aliae Mohamed-Hussein, MD, 01222302352 ext. 002, aliaehussein@gmail.com
About this study
Official title: Effect of Residual Myocardial Ischemia on Recovery of Left Ventricular Function After Primary Percutaneous Coronary Intervention
Recovery of the left ventricular function is variable from one patient to another, thus assessment of cardiac function by measuring left ventricular ejection fraction using echocardiography is the most common in the daily clinical practice. However, this technique has limitation related with its intra- and interobserver variability. A recent technique, 2D speckle tracking for assessing global longitudinal strain, has been introduced to reduce the variability and potentially has a higher accuracy. Speckle tracking is a method which uses two dimensions recording for measuring quantity of movement of myocardium in several segments.
Speckle-tracking echocardiography is a current noninvasive ultrasound imaging technique that allows for an objective and quantitative evaluation of global and regional myocardial function independently from the angle of insonation and from cardiac translational movements,
Read the detailed description
Authors using 2D speckle tracking found that subclinical LV systolic dysfunction is common in patients with isolated severe mitral stenosis (MS) and is determined primarily by the hemodynamic variables of MS severity and reduced LV filling. BMV results in rapid recovery of LV systolic function in these patients through improvement in LV diastolic loading. These findings suggest that LV contractile properties in MS are modulated predominantly by LV diastolic filling rather than myocardial structural abnormality.
- Being tested
- Speckle tracking echocardiography
- Keywords
- Speckle tracking, 2D echocardiography, Left ventricle residual function, PCI, percutaneous coronary intervention, single coronary artery, multiple coronary arteries
- Medical subject headings
- Myocardial Infarction, Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speckle tracking echocardiographyDiagnostic test
Also called 2 D echocardiography
assess left ventricular function on admission and after 40 days
| Study group | Role | What they receive |
|---|---|---|
| Group A | single coronary artery lesion Receives: Diagnostic Test: Speckle tracking echocardiography | |
| Group B | multiple coronary artery lesions Receives: Diagnostic Test: Speckle tracking echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing change of left ventricular function
measure ejection fraction
Measured: baseline and after 40 days of PCI
Secondary outcomes (1)
Major adverse cardiovascular events
non fatal myocardial infarction, non fatal stroke, CV death
Measured: 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start1 Nov 2019 (estimated)
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karim Mohamed Eltaher Abdelrahman Aly, Assiut University
- Investigators
- Amr A Youssef, MD, Study chair, Professor of CardiologyMohamed A Abdel Hafez, MD, Study director, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04103008
- Sponsor's protocol ID
- AssiutU2019
- Status last verified
- Sep 2019
- First submitted
- 21 Sep 2019
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Abdelhafez MA, Aly KME, Youssef AAA. Effect of residual myocardial ischemia on recovery of left ventricular function after primary percutaneous coronary intervention. BMC Cardiovasc Disord. 2024 Mar 19;24(1):164. doi: 10.1186/s12872-024-03777-3.
PubMed 38504186
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Residual Myocardial Ischemia on Recovery of Left Ventricular Function After Primary Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT04103008
- Acronym / sponsor ID
- AssiutU2019
- Keywords
- Speckle tracking, 2D echocardiography, Left ventricle residual function, PCI, percutaneous coronary intervention, single coronary artery, multiple coronary arteries
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (estimated)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 25 Sep 2019 (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.
Recovery of the left ventricular function is variable from one patient to another, thus assessment of cardiac function by measuring left ventricular ejection fraction using echocardiography is the most common in the daily clinical practice. However, this technique has limitation related with its intra- and interobserver variability. A recent technique, 2D speckle tracking for assessing global longitudinal strain, has been introduced to reduce the variability and potentially has a higher accuracy. Speckle tracking is a method which uses two dimensions recording for measuring quantity of movement of myocardium in several segments.
Speckle-tracking echocardiography is a current noninvasive ultrasound imaging technique that allows for an objective and quantitative evaluation of global and regional myocardial function independently from the angle of insonation and from cardiac translational movements,
Detailed description
Authors using 2D speckle tracking found that subclinical LV systolic dysfunction is common in patients with isolated severe mitral stenosis (MS) and is determined primarily by the hemodynamic variables of MS severity and reduced LV filling. BMV results in rapid recovery of LV systolic function in these patients through improvement in LV diastolic loading. These findings suggest that LV contractile properties in MS are modulated predominantly by LV diastolic filling rather than myocardial structural abnormality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Diagnostic Test: Speckle tracking echocardiographysingle coronary artery lesion |
| Group B | – | Diagnostic Test: Speckle tracking echocardiographymultiple coronary artery lesions |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with acute myocardial infarction with single or multiple coronary artery lesions seen after PCI on admission and after 40 days
Key inclusion criteria (1 listed)
- Patients with acute myocardial infarction eligible for PCI seen on admission and after 40 days
Key exclusion criteria (3 listed)
- cardiomyopathy
- cancer
- on cytostatic treatment.
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 echocardiographyAlso: 2 D echocardiographyassess left ventricular function on admission and after 40 days | Diagnostic test | Group A, Group B |
Primary outcome
Assessing change of left ventricular function
Time frame: baseline and after 40 days of PCI
measure ejection fraction
1 secondary outcome
Major adverse cardiovascular events
Time frame: 40 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Derived from this study: PubMed 38504186Abdelhafez MA, Aly KME, Youssef AAA. Effect of residual myocardial ischemia on recovery of left ventricular function after primary percutaneous coronary intervention. BMC Cardiovasc Disord. 2024 Mar 19;24(1):164. doi: 10.1186/s12872-024-03777-3.
- Individual participant dataSharing planned: Undecided
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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.
Amr A Youssef, MD study chair
Professor of Cardiology
Mohamed A Abdel Hafez, MD study director
Associate Professor
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 Myocardial Infarction and Echocardiography 2D, run by Assiut 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 1 inclusion and 3 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 25 Sep 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karim ME Aly (01068545195 ext. 002, karimeltaher294@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing change of left ventricular function (time frame: baseline and after 40 days of PCI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04103008, which also lists 1 linked publication.
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 25 Sep 2019; AzTrials last refreshed its copy on 29 Oct 2026.