Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05593822
Other study ID # Relationship between PPCI &ECG
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 2022
Est. completion date December 2025

Study information

Verified date October 2022
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date December 2025
Est. primary completion date October 2025
Accepts healthy volunteers No
Gender All
Age group 25 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
primary percutaneous intervention
percutaneous catheterization through peripheral arteries to coronary arteries

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
6 month
Primary 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)
6 month
Primary 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.
1 year
Secondary left ventricular function left ventricular function before and after PCI measured by echocardiography (by simpson"s method) 1 year
See also
  Status Clinical Trial Phase
Recruiting NCT06013813 - Conventional vs. Distal Radial Access Outcomes in STEMI Patients Treated by PCI N/A
Completed NCT04507529 - Peer-mentor Support for Older Vulnerable Myocardial Infarction Patients N/A
Recruiting NCT06066970 - Cardiac Biomarkers for the Quantification of Myocardial Damage After Cardiac Surgery
Recruiting NCT03620266 - Effects of Bilberry and Oat Intake After Type 2 Diabetes and/or MI N/A
Completed NCT04097912 - Study to Gather Information to What Extent Patients Follow the Treatment Regimen of Low-dose Aspirin for Primary and Secondary Prevention of Diseases of the Heart and Blood Vessels
Completed NCT04153006 - Comparison of Fingerstick Versus Venous Sample for Troponin I.
Completed NCT03668587 - Feasibility and Security of a Rapid Rule-out and rule-in Troponin Protocol in the Management of NSTEMI in an Emergency Departement
Recruiting NCT01218776 - International Survey of Acute Coronary Syndromes in Transitional Countries
Completed NCT03076801 - Does Choral Singing Help imprOve Stress in Patients With Ischemic HeaRt Disease? N/A
Recruiting NCT05371470 - Voice Analysis Technology to Detect and Manage Depression and Anxiety in Cardiac Rehabilitation N/A
Recruiting NCT04562272 - Attenuation of Post-infarct LV Remodeling by Mechanical Unloading Using Impella-CP N/A
Completed NCT04584645 - A Digital Flu Intervention for People With Cardiovascular Conditions N/A
Active, not recruiting NCT04475380 - Complex All-comers and Patients With Diabetes or Prediabetes, Treated With Xience Sierra Everolimus-eluting Stents
Not yet recruiting NCT06007950 - Time-restricted Eating Study (TRES): Impacts on Anthropometric, Cardiometabolic and Cardiovascular Health N/A
Withdrawn NCT05327855 - Efficacy and Safety of OPL-0301 Compared to Placebo in Adults With Post-Myocardial Infarction (MI) Phase 2
Recruiting NCT02876952 - High Intensity Aerobic Interval Training With Mediterranean Diet Recommendations in Post-Myocardial Infarct Patients N/A
Completed NCT02917213 - Imaging Silent Brain Infarct And Thrombosis in Acute Myocardial Infarction
Completed NCT02711631 - Feasibility and Effectiveness of Remote Virtual Reality-Based Cardiac Rehabilitation N/A
Completed NCT02305602 - A Study of VentriGel in Post-MI Patients Phase 1
Completed NCT02552407 - Thrombectomy in ST Elevation Myocardial Infarction, an Individual Patient Meta-analysis N/A