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
Primary Purpose
Myocardial Infarction
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
primary percutaneous intervention
Sponsored by
About this trial
This is an interventional other trial for Myocardial Infarction
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
patient with STEMI
Arm Description
Outcomes
Primary Outcome Measures
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)
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)
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.
Secondary Outcome Measures
left ventricular function
left ventricular function before and after PCI measured by echocardiography (by simpson"s method)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05593822
Brief 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
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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2022 (Anticipated)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patient with STEMI
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
primary percutaneous intervention
Intervention Description
percutaneous catheterization through peripheral arteries to coronary arteries
Primary Outcome Measure Information:
Title
QRS width changes before and after PCI
Description
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)
Time Frame
6 month
Title
Tpe interval changes before and after PCI
Description
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)
Time Frame
6 month
Title
MBG during PCI .
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
left ventricular function
Description
left ventricular function before and after PCI measured by echocardiography (by simpson"s method)
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
12. IPD Sharing Statement
Learn more about this trial
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
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