STEMI - ST Elevation Myocardial InfarctionNCT05107076
Effect of PPCI on Diastolic Function & Levels of Galactin-3 in Patients With STEMI
An observational study of STEMI - ST Elevation Myocardial Infarction, run by Assiut University at 1 site in Egypt.
Trial summary
2D Echocardiography with color Doppler assessment: It will be done within 24 h after PPCI Peripheral blood samples were obtained within 48 hours after acute MI, and the serum will be frozen at -70°C until tested for Galactin-3 level. Follow up 2D Doppler echocardiography: will be repeated at 40 days of the event. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- STEMI - ST Elevation Myocardial Infarction
- What is being tested?
- 2D Echocardiography with color Doppler assessment & Galactin-3 level in blood
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2021to May 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with age > 18 years who will present in the emergency department within 12 h (hrs) of the onset of ischemic chest pain \& fulfill the diagnostic criteria of acute STEMI as defined by the universal definition of Myocardial Infarction (9) and are eligible for primary PCI will be included in this study.
Who may be able to join
- All patients of sample size admitted to the cardiology department of Assiut university hospital with:
- Acute typical chest pain
- Positive cardiac enzymes.
- ECG shows ST-segment elevation MI
- Documented occlusion of CA then treatment by PPCI
Who cannot join
- 1. Patients with well-known factors of left ventricular diastolic dysfunctions, including high blood pressure (over 140/90 mmHg), hypertrophic cardiomyopathy, left ventricular hypertrophy, bundle branch block, ventricular fibrillation, ventricular arrhythmia, severe valvular disease, complete heart block, and previous CABG.
- 2. Patients with the end-stage renal disease usually have markedly increased galactin-3 levels 3. Prior use of thrombolytic agents 4. Refusal of PPCI due to social or religious concerns 5. ST elevation on ECG without obvious coronary artery diseases such as acute myocarditis, early repolarization, or Takotsubo cardiomyopathy 6. Atrial fibrillation at the time of echocardiography examination.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine Assiut University
Asyut, Asyut Governorate
Mariam Hanna
About this study
- 2D Echocardiography with color Doppler assessment: It will be done within 24 h after PPCI
- Peripheral blood samples were obtained within 48 hours after acute MI, and the serum will be frozen at -70°C until tested for Galactin-3 level.
- Follow up 2D Doppler echocardiography: will be repeated at 40 days of the event.
Read the detailed description
2D Echocardiography with color Doppler assessment:
It will be done within 24 h after PPCI. Measurements will be as following:
- Pulsed wave (PW) Doppler will be performed in the apical 4chamber view within a 3 mm sample volume at the tip of the mitral leaflets to obtain mitral inflow velocities to assess LV filling.
- E (early diastolic)/A (late diastolic) - Using PW Doppler, the peak E and A velocities were recorded, then the ratio of E/A will be calculated.
- IVRT (isovolumic relaxation time) - derived by placing the cursor of Continuous wave (CW) Doppler in the LV outflow tract to simultaneously display the end of aortic ejection and the onset of mitral inflow.
- Deceleration time (DT) - from the peak of E wave to baseline.
- E/e'- PW tissue Doppler imaging (TDI) was performed in the apical views to acquire mitral annular velocities. The sample volume will be positioned at or 1 cm within the mitral leaflet's septal and lateral insertion sites.
- Left atrial volume and left atrial volume index (LAVI) - The maximal left atrial (LA) volume measured from the apical four-chamber view using the modified Simpson method in end-systole before mitral valve opening. The LAVI obtained for all patients by dividing the LA volume by the body surface area.
Biochemical measurements:
Peripheral blood samples were obtained within 48 hours after acute MI, and the serum will be frozen at -70°C until tested for Galactin-3 level.
Follow up 2D Doppler echocardiography:
All previous echocardiographic measurements will be repeated at 40 days of the event.
- Being tested
- 2D Echocardiography with color Doppler assessment & Galactin-3 level in blood
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2D Echocardiography with color Doppler assessment & Galactin-3 level in bloodDiagnostic test
- Measurements will be
- Pulsed wave (PW) Doppler
- E (early diastolic)/A (late diastolic) - Using PW Doppler
- IVRT (isovolumic relaxation time)
- Deceleration time (DT) - from the peak of E wave to baseline.
- E/e'- PW tissue Doppler imaging (TDI)
- Left atrial volume and left atrial volume index (LAVI)
- Peripheral blood samples will be obtained within 48 hours after acute MI, and the serum will be frozen at -70°C until tested for Galactin-3 level.
| Study group | Role | What they receive |
|---|---|---|
| STEMI patients who underwent PPCI | 2D Echocardiography with color Doppler assessment will be done within 24 h after PPCI
Biochemical measurements:
Peripheral blood samples were obtained within 48 hours after acute MI, and the serum will be frozen at -70°C until tested for Galactin-3 level.
Follow up 2D Doppler echocardiography will be repeated at 40 days of the event. Receives: Diagnostic Test: 2D Echocardiography with color Doppler assessment & Galactin-3 level in blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute effect of PPCI in STEMI patients on diastolic function and Galactin-3 level
Determine the acute effect of PPCI in STEMI patients on the level of Galectin 3 and diastolic function within 48 hrs of the event.
Measured: 48 hrs
Secondary outcomes (1)
Correlation to patients' outcomes especially in those with initial high serum Galactin-3
Correlating effect of PPCI on patients outcomes and impact on diastolic function, with consideration to those with initial high serum galectin levels at 40 days of the procedure.
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 posted4 Nov 2021
- Study startNov 2021 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for STEMI - ST Elevation 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Bady Adly Hanna, Assiut University
- Investigators
- Hatem Helmy, Professor, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05107076
- Sponsor's protocol ID
- PPCI in STEMI patients
- Status last verified
- Oct 2021
- First submitted
- 25 Oct 2021
- Last updated
- 4 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karaye KM, Sani MU. Factors associated with poor prognosis among patients admitted with heart failure in a Nigerian tertiary medical centre: a cross-sectional study. BMC Cardiovasc Disord. 2008 Jul 22;8:16. doi: 10.1186/1471-2261-8-16.
PubMed 18644161McManus DD, Chinali M, Saczynski JS, Gore JM, Yarzebski J, Spencer FA, Lessard D, Goldberg RJ. 30-year trends in heart failure in patients hospitalized with acute myocardial infarction. Am J Cardiol. 2011 Feb 1;107(3):353-9. doi: 10.1016/j.amjcard.2010.09.026.
PubMed 21256998
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of PPCI on Diastolic Function & Levels of Galactin-3 in Patients With STEMI
- ClinicalTrials.gov ID
- NCT05107076
- Acronym / sponsor ID
- PPCI in STEMI patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2021 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 4 Nov 2021 (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.
- 2D Echocardiography with color Doppler assessment: It will be done within 24 h after PPCI
- Peripheral blood samples were obtained within 48 hours after acute MI, and the serum will be frozen at -70°C until tested for Galactin-3 level.
- Follow up 2D Doppler echocardiography: will be repeated at 40 days of the event.
Detailed description
2D Echocardiography with color Doppler assessment:
It will be done within 24 h after PPCI. Measurements will be as following:
- Pulsed wave (PW) Doppler will be performed in the apical 4chamber view within a 3 mm sample volume at the tip of the mitral leaflets to obtain mitral inflow velocities to assess LV filling.
- E (early diastolic)/A (late diastolic) - Using PW Doppler, the peak E and A velocities were recorded, then the ratio of E/A will be calculated.
- IVRT (isovolumic relaxation time) - derived by placing the cursor of Continuous wave (CW) Doppler in the LV outflow tract to simultaneously display the end of aortic ejection and the onset of mitral inflow.
- Deceleration time (DT) - from the peak of E wave to baseline.
- E/e'- PW tissue Doppler imaging (TDI) was performed in the apical views to acquire mitral annular velocities. The sample volume will be positioned at or 1 cm within the mitral leaflet's septal and lateral insertion sites.
- Left atrial volume and left atrial volume index (LAVI) - The maximal left atrial (LA) volume measured from the apical four-chamber view using the modified Simpson method in end-systole before mitral valve opening. The LAVI obtained for all patients by dividing the LA volume by the body surface area.
Biochemical measurements:
Peripheral blood samples were obtained within 48 hours after acute MI, and the serum will be frozen at -70°C until tested for Galactin-3 level.
Follow up 2D Doppler echocardiography:
All previous echocardiographic measurements will be repeated at 40 days of the event.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STEMI patients who underwent PPCI | – | Diagnostic Test: 2D Echocardiography with color Doppler assessment & Galactin-3 level in blood2D Echocardiography with color Doppler assessment will be done within 24 h after PPCI Biochemical measurements: Peripheral blood samples were obtained within 48 hours after acute MI, and the serum will be frozen at -70°C until tested for Galactin-3 level. Follow up 2D Doppler echocardiography will be repeated at 40 days of the event. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with age > 18 years who will present in the emergency department within 12 h (hrs) of the onset of ischemic chest pain \& fulfill the diagnostic criteria of acute STEMI as defined by the universal definition of Myocardial Infarction (9) and are eligible for primary PCI will be included in this study.
Key inclusion criteria (5 listed)
- All patients of sample size admitted to the cardiology department of Assiut university hospital with:
Key exclusion criteria (2 listed)
- 1. Patients with well-known factors of left ventricular diastolic dysfunctions, including high blood pressure (over 140/90 mmHg), hypertrophic cardiomyopathy, left ventricular hypertrophy, bundle branch block, ventricular fibrillation, ventricular arrhythmia, severe valvular disease, complete heart block, and previous CABG.
- 2. Patients with the end-stage renal disease usually have markedly increased galactin-3 levels 3. Prior use of thrombolytic agents 4. Refusal of PPCI due to social or religious concerns 5. ST elevation on ECG without obvious coronary artery diseases such as acute myocarditis, early repolarization, or Takotsubo cardiomyopathy 6. Atrial fibrillation at the time of echocardiography examination.
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 Echocardiography with color Doppler assessment & Galactin-3 level in blood* Measurements will be 1. Pulsed wave (PW) Doppler 2. E (early diastolic)/A (late diastolic) - Using PW Doppler 3. IVRT (isovolumic relaxation time) 4. Deceleration time (DT) - from the peak of E wave to baseline. 5. E/e'- PW tissue Doppler imaging (TDI) 6. Left atrial volume and left atrial volume index (LAVI) * Peripheral blood samples will be obtained within 48 hours after acute MI, and the serum will be frozen at -70°C until tested for Galactin-3 level. | Diagnostic test | STEMI patients who underwent PPCI |
Primary outcome
Acute effect of PPCI in STEMI patients on diastolic function and Galactin-3 level
Time frame: 48 hrs
Determine the acute effect of PPCI in STEMI patients on the level of Galectin 3 and diastolic function within 48 hrs of the event.
1 secondary outcome
Correlation to patients' outcomes especially in those with initial high serum Galactin-3
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 4 Nov 2021.
- Background: PubMed 18644161Karaye KM, Sani MU. Factors associated with poor prognosis among patients admitted with heart failure in a Nigerian tertiary medical centre: a cross-sectional study. BMC Cardiovasc Disord. 2008 Jul 22;8:16. doi: 10.1186/1471-2261-8-16.
- Background: PubMed 21256998McManus DD, Chinali M, Saczynski JS, Gore JM, Yarzebski J, Spencer FA, Lessard D, Goldberg RJ. 30-year trends in heart failure in patients hospitalized with acute myocardial infarction. Am J Cardiol. 2011 Feb 1;107(3):353-9. doi: 10.1016/j.amjcard.2010.09.026.
- 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, Professor principal investigator
Assiut University
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 STEMI - ST Elevation Myocardial Infarction, 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 5 inclusion and 2 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 4 Nov 2021. 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 Mariam Hanna, Resident (+201069862210, mariam.abdelmalak@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute effect of PPCI in STEMI patients on diastolic function and Galactin-3 level (time frame: 48 hrs). 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 NCT05107076, which also lists 2 linked publications.
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 4 Nov 2021.