search
Back to results

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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Myocardial Infarction

Eligibility Criteria

25 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Typical ongoing ischemic chest pain for >30 minutes
  2. ST elevation ≥1mm in ≥2 contiguous leads (2 mm for pericordial leads)
  3. Successful primary PCI (patent infarct related artery)

Exclusion Criteria:

  1. Patients with known bundle branch block
  2. Patients with advanced degree of atrioventricular block or electrolyte disturbances.
  3. Permanent pacemaker
  4. Cardiomyopathies, chronic kidney disease.
  5. 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

    First Posted
    October 9, 2022
    Last Updated
    October 25, 2022
    Sponsor
    Assiut University
    search

    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

    We'll reach out to this number within 24 hrs