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

June 30, 2018 updated by: MS Roshdy, Assiut University
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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
235

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
      • Assiut, Egypt, 71641
        • Recruiting
        • Assiut University
        • Contact:
        • Principal Investigator:
          • Hossam El-Araby
        • Principal Investigator:
          • Hatem Helmy
        • Principal Investigator:
          • Marina Samir

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

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).

Description

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:

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Correlation of QT dispersion on 12-lead surface ECG with myocardial reperfusion
Time Frame: 1 year
Use 12 lead ECG to calculate QT interval and QT dispersion comparing ECG before and after myocardial reperfusion.
1 year
Evaluation of myocardial perfusion by coronary angiography by assessing 2 parameters TIMI flow and myocardial blush grade
Time Frame: 1 year
Use coronary angiography to detect myocardial blush grade and TIMI flow to assess myocardial reperfusion
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Hatem Helmy, Assistant Professor
  • Study Chair: Hosam Hasan, Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 1, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 3, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17100310

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on ST Elevation Myocardial Infarction

Clinical Trials on ECG

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings