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Status unknownNCT03269838Updated Jul 3, 2018

Correlation of QT Dispersion With Myocardial Perfusion in Patients With ST Elevation Myocardial Infarction Treated by Primary Per Cutaneous Coronary Intervention

An observational study in ST Elevation Myocardial Infarction, sponsored by Assiut University. Status unknown at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2018-07-03.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Jun 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
235
Sex
All
01

Study summary

To correlate QT dispersion on 12-lead surface ECG with myocardial reperfusion evaluated by myocardial blush grade and Thrombolysis in myocardial infarction (TIMI) flow grades in patients with ST elevation myocardial infarction treated by Primary Per cutaneous coronary intervention

Read the detailed description

Worldwide, coronary artery disease (CAD) is the most frequent cause of death. Over seven million people every year die from CAD, accounting for 12.8% of all deaths. Every sixth man and every seventh woman in Europe die from myocardial infarction. The in-hospital mortality of STEMI patients in the national registries of the European society of cardiology (ESC) countries varies between 6% and 14%.

ST elevation myocardial infarction (STEMI) generally results from intraluminal thrombus formation and occlusion of a ruptured or an unstable plaque .

The main goal of therapy in STEMI is to restore microvascular flow and sustain the myocardial perfusion .

Reperfusion therapy for acute myocardial infarction (AMI) is aimed at achieving prompt restoration of myocardial perfusion to maximize preservation of the electrical and mechanical integrity of the jeopardized myocardium. Percutaneous coronary intervention (PCI) has increased the rate of successful recanalization of infarct-related arteries (IRAs) to >90% .

A variety of markers including ECG and coronary angiography have been utilized to assess myocardial reperfusion .

The prolongation of QRS duration,evaluated by a standard 12-lead ECG, is a marker of ventricular dysfunction and has been associated with a poor prognosis in STEMI .

QT-interval parameters are potentially proposed as available non-invasive markers for assessing the ventricular homogeneity as well as for predicting electrical instability ,QT interval (QTI) is defined as the longest interval from the beginning of the QRS complex to the end of the T-wave; QT dispersion (QTd) is defined as the difference between the longest and shortest QTI, and reflects electrical activity of the ventricles . .

The prolongation of the latter parameter is a main predictor for fatal arrhythmia in patients with myocardial infarction (MI) .

The measurement of QTI and QTd parameters are dependent on heart rate and can be corrected by the QT correction formulas, which are termed the corrected QTI (QTc) and QTd (QTcd) .

Myocardial blush grade (MBG) is validated measurement of myocardial perfusion . The MBG is used to assess the washout of myocardial blush during angiography. Grade 0 is defined as the failure of the contrast to enter the microvasculature. In grade 1 cases, contrast enters slowly, but fails to exit the microvasculature. Grade 2 defines delayed entry and exit from the microvasculature. Finally, grade 3 indicates normal entry and exit from the microvasculature .

ECG is a necessary, simple, rapid and non invasive tool for the diagnosis of myocardial infarction and evaluation of myocardial reperfusion that still to be investigated . QT dispersion is a crude and approximate measure of a general abnormality of repolarization; it reflects inhomogeneity of ventricular repolarization . This measurement is an attempt to distinguish between myocardium that is homogeneous from myocardium that displays inhomogeneity, which is accompanied by increased dispersion of the ventricular recovery times and prolongation of repolarization

02

Conditions studied

03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Sampling method
Probability sample

Study population

This cross sectional observational study will include patients with acute STEMI of different ages from cardiology department, Assiut University Hospital who will undergo primary percutaneous coronary intervention (PCI).

Inclusion criteria

  • Patients will be enrolled in this study if they fulfilled the criteria of acute ST elevation myocardial infarction eligible to be treated with primary Percutaneous coronary intervention

Exclusion criteria

Exclusion Criteria:

  1. Non-ST elevation myocardial infarction, prior history of myocardial infarction or surgical revascularization,
  2. Electrolyte disturbance.
  3. history of medications that may affect QT (anti-arrhythmic, anti-psychotic, and anti-depressant drugs),
  4. patients with cardiogenic shock or needing IABP.
  5. patients with previous CABG.
  6. Patients with implantable devices and pacemakers.
04

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
235 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testECG

    Primary Percutaneous coronary intervention

    Also known as: Primary Percutaneous coronary intervention

05

What researchers measure

Primary outcomes

  1. Correlation of QT dispersion on 12-lead surface ECG with myocardial reperfusion

    Use 12 lead ECG to calculate QT interval and QT dispersion comparing ECG before and after myocardial reperfusion.

    Time frame: 1 year

  2. Evaluation of myocardial perfusion by coronary angiography by assessing 2 parameters TIMI flow and myocardial blush grade

    Use coronary angiography to detect myocardial blush grade and TIMI flow to assess myocardial reperfusion

    Time frame: 1 year

06

Study locations

1 of 1 sites recruiting
  • Assiut university
    Assiut, 71641, Egypt
    • Marina Samir, master · Contact · morajesus24@outlook.com · 01204836349
    • Hossam El-Araby · Principal investigator
    • Hatem Helmy · Principal investigator
    • Marina Samir · Principal investigator
    Recruiting
07

References and documents

Publications

  • Karahan Z, Yaylak B, Ugurlu M, Kaya I, Ucaman B, Ozturk O. QRS duration: a novel marker of microvascular reperfusion as assessed by myocardial blush grade in ST elevation myocardial infarction patients undergoing a primary percutaneous intervention. Coron Artery Dis. 2015 Nov;26(7):583-6. doi: 10.1097/MCA.0000000000000285. PubMed 26166018 ↗
08

Registry details

Key details

Study ID
NCT03269838
Lead sponsor
Assiut University
Responsible party
MS Roshdy (Principal Investigator, Assiut University) — Principal investigator
First posted
Sep 1, 2017
Start date
Jul 2018 (estimated)
Primary completion
Jul 2019 (estimated)
Completion
Sep 2019 (estimated)
Last update
Jul 3, 2018

Study contacts

Marina Samir, master
Contact
morajesus24@outlook.com
01204836349
Hatem Helmy
study chair · assistant professor
Hosam Hasan
study chair · professor

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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