Myocardial InfarctionNCT05593822
The Relationship Between Myocardial Blush Grade and T-P-e Interval and QRS Width: Impact on In-Hospital Outcome After Successful Primary Percutaneous Coronary Intervention
A study testing primary percutaneous intervention in people with Myocardial Infarction, run by Assiut University.
Trial summary
Aim of the work: Primary aim; is to assess relation between non invasive ECG findings, Tpe interval and QRS width and MBG in in patients with successful PCI in patients with STEMI. Secondary aim; is to assess impact of Tpe, QRS width and MBG on in hospital outcome Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- primary percutaneous intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Oct 2022to Dec 2025
- Phase
- Interventional
- 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 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Typical ongoing ischemic chest pain for >30 minutes
- ST elevation ≥1mm in ≥2 contiguous leads (2 mm for pericordial leads)
- Successful primary PCI (patent infarct related artery)
Who cannot join
- Patients with known bundle branch block
- Patients with advanced degree of atrioventricular block or electrolyte disturbances.
- Permanent pacemaker
- Cardiomyopathies, chronic kidney disease.
- Previously revascularized patients either by PCI or CABG surgery
About this study
Official title: The Relationship Between Myocardial Blush Grade and T-P-e Interval and QRS Width: Impact on In-Hospital Outcome After Successful Primary Percutaneous Coronary Intervention.
Aim of the work:
Primary aim; is to assess relation between non invasive ECG findings, Tpe interval and QRS width and MBG in in patients with successful PCI in patients with STEMI.
Secondary aim; is to assess impact of Tpe, QRS width and MBG on in hospital outcome
Read the detailed description
Primary percutaneous coronary intervention (PCI) is the treatment of choice for patients presenting with acute ST-elevation myocardial infarction (STEMI). Rapid reperfusion of infarct-related artery in STEMI is associated with substantial improvement in prognosis; however, providing epicardial flow, doesn't always mean a normal tissue perfusion. Myocardial perfusion, when assessed by myocardial blush grade (MBG) is an independent predictor of both short and long-term major adverse cardiac outcomes. (Brener SJ et al 2011, Kampinga MA 2010 and Arefin MM et al 2022)
-In this patient population, arrhythmias are also a major cause of mortality and morbidity. Repolarization heterogeneities on surface electrocardiograms (ECG) is considered as predictors of malignant ventricular arrhythmias and sudden cardiac death in patients with STEMI (Haarmark C et al 2009). The terminal part of repolarization, measured as the interval from the peak to the end of the T wave (Tpe), is a relatively indicator of risk of ventricular arrhythmias, and accumulating data suggest that T peak-to-end interval and Tpe/QT ratio are more sensitive arrhythmia markers than the older index QT dispersion (Korantzopoulos P et al 2011 Rautaharju PM et al 2005 and Duyuler PT et al 2017) ECG assessment of reperfusion therapy is mainly based on changes of the ST-segment, but the significance of the QRS duration is still not very well established. Prolonged QRS duration is associated with an increased risk of impaired ventricular systolic function and adverse effects. (Masami K et al 2011, Tsukahara K et al 2005). While ST-segment resolution is related to myocardial perfusion and cell membrane integrity, MBG reflects myocardial perfusion and microvascular patency. It is a qualitative visual assessment of the amount of contrast medium filling a territory supplied by an epicardial coronary artery. Studies are lacking that can assess the correlation between the noninvasive (QRS duration) and the invasive marker MBG of myocardial reperfusion (Yusuf J et al 2018) . The investigators will study the relation between the QRS width and MBG. The rationale was to test that whether any change in QRS duration in post-intervention patients will reflect impaired or good microvascular perfusion as assessed by the MBG.
So in the study the investigators will assess the relation between non invasive ECG findings (Tpe interval and QRS width) with invasive MBG as indicator to microvascular perfusion in patients with successful PCI in patients with STEMI and their relation to in hospital outcome
- Conditions
- Myocardial Infarction
- Being tested
- primary percutaneous intervention
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
primary percutaneous interventionProcedure or surgery
percutaneous catheterization through peripheral arteries to coronary arteries
| Study group | Role | What they receive |
|---|---|---|
| patient with STEMI | Other | Not described Receives: Procedure: primary percutaneous intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
QRS width changes before and after PCI
All the patients will be suspected to the following Electrocardiogram At admission and 90 minutes after the PCI,
-QRS complex will be measured from the start to the end of the complex,(in milli-seconds)
Measured: 6 month
Tpe interval changes before and after PCI
All the patients will be suspected to the following Electrocardiogram At admission and 90 minutes after the PCI,
-Tpe interval will be measured from the peak of T wave to the end of it (in milli-seconds)
Measured: 6 month
MBG during PCI .
primary PCI The contrast density in the distal myocardial region of the IRA is graded in comparison with the blush of non-IRA myocardial regions on cine film at 25 frames per second on the best projection along at least 3 cardiac cycles duration to ensure washout.
- Patients with no myocardial blush are graded as MBG 0,
- those with minimal myocardial blush are graded as MBG 1,
- those with moderate myocardial blush are graded as MBG 2
- and patients with normal myocardial blush are graded as MBG 3.
Measured: 1 year
Secondary outcomes (1)
left ventricular function
left ventricular function before and after PCI measured by echocardiography (by simpson"s method)
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 posted25 Oct 2022
- Study startOct 2022 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionDec 2025 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Amr Ahmed Aly, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05593822
- Sponsor's protocol ID
- Relationship between PPCI &ECG
- Status last verified
- Oct 2022
- First submitted
- 9 Oct 2022
- Last updated
- 27 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Myocardial Blush Grade and T-P-e Interval and QRS Width: Impact on In-Hospital Outcome After Successful Primary Percutaneous Coronary Intervention.
- ClinicalTrials.gov ID
- NCT05593822
- Acronym / sponsor ID
- Relationship between PPCI &ECG
- Conditions
- Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 25 Oct 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.
Aim of the work:
Primary aim; is to assess relation between non invasive ECG findings, Tpe interval and QRS width and MBG in in patients with successful PCI in patients with STEMI.
Secondary aim; is to assess impact of Tpe, QRS width and MBG on in hospital outcome
Detailed description
Primary percutaneous coronary intervention (PCI) is the treatment of choice for patients presenting with acute ST-elevation myocardial infarction (STEMI). Rapid reperfusion of infarct-related artery in STEMI is associated with substantial improvement in prognosis; however, providing epicardial flow, doesn't always mean a normal tissue perfusion. Myocardial perfusion, when assessed by myocardial blush grade (MBG) is an independent predictor of both short and long-term major adverse cardiac outcomes. (Brener SJ et al 2011, Kampinga MA 2010 and Arefin MM et al 2022)
-In this patient population, arrhythmias are also a major cause of mortality and morbidity. Repolarization heterogeneities on surface electrocardiograms (ECG) is considered as predictors of malignant ventricular arrhythmias and sudden cardiac death in patients with STEMI (Haarmark C et al 2009). The terminal part of repolarization, measured as the interval from the peak to the end of the T wave (Tpe), is a relatively indicator of risk of ventricular arrhythmias, and accumulating data suggest that T peak-to-end interval and Tpe/QT ratio are more sensitive arrhythmia markers than the older index QT dispersion (Korantzopoulos P et al 2011 Rautaharju PM et al 2005 and Duyuler PT et al 2017) ECG assessment of reperfusion therapy is mainly based on changes of the ST-segment, but the significance of the QRS duration is still not very well established. Prolonged QRS duration is associated with an increased risk of impaired ventricular systolic function and adverse effects. (Masami K et al 2011, Tsukahara K et al 2005). While ST-segment resolution is related to myocardial perfusion and cell membrane integrity, MBG reflects myocardial perfusion and microvascular patency. It is a qualitative visual assessment of the amount of contrast medium filling a territory supplied by an epicardial coronary artery. Studies are lacking that can assess the correlation between the noninvasive (QRS duration) and the invasive marker MBG of myocardial reperfusion (Yusuf J et al 2018) . The investigators will study the relation between the QRS width and MBG. The rationale was to test that whether any change in QRS duration in post-intervention patients will reflect impaired or good microvascular perfusion as assessed by the MBG.
So in the study the investigators will assess the relation between non invasive ECG findings (Tpe interval and QRS width) with invasive MBG as indicator to microvascular perfusion in patients with successful PCI in patients with STEMI and their relation to in hospital outcome
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient with STEMI | Other | Procedure: primary percutaneous intervention |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Typical ongoing ischemic chest pain for >30 minutes
- ST elevation ≥1mm in ≥2 contiguous leads (2 mm for pericordial leads)
- Successful primary PCI (patent infarct related artery)
Key exclusion criteria (5 listed)
- Patients with known bundle branch block
- Patients with advanced degree of atrioventricular block or electrolyte disturbances.
- Permanent pacemaker
- Cardiomyopathies, chronic kidney disease.
- Previously revascularized patients either by PCI or CABG surgery
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 |
|---|---|---|
| primary percutaneous interventionpercutaneous catheterization through peripheral arteries to coronary arteries | Procedure or surgery | patient with STEMI |
Primary outcome
QRS width changes before and after PCI
Time frame: 6 month
All the patients will be suspected to the following Electrocardiogram At admission and 90 minutes after the PCI, -QRS complex will be measured from the start to the end of the complex,(in milli-seconds)
Tpe interval changes before and after PCI
Time frame: 6 month
All the patients will be suspected to the following Electrocardiogram At admission and 90 minutes after the PCI, -Tpe interval will be measured from the peak of T wave to the end of it (in milli-seconds)
MBG during PCI .
Time frame: 1 year
primary PCI The contrast density in the distal myocardial region of the IRA is graded in comparison with the blush of non-IRA myocardial regions on cine film at 25 frames per second on the best projection along at least 3 cardiac cycles duration to ensure washout. * Patients with no myocardial blush are graded as MBG 0, * those with minimal myocardial blush are graded as MBG 1, * those with moderate myocardial blush are graded as MBG 2 * and patients with normal myocardial blush are graded as MBG 3.
1 secondary outcome
left ventricular function
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing primary percutaneous intervention in people with 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 3 inclusion and 5 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 27 Oct 2022. 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?
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?
QRS width changes before and after PCI (time frame: 6 month). The study lists 3 primary outcomes in all. 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 27 Oct 2022.