ST Elevation Myocardial InfarctionNCT03269838
Correlation of QT Dispersion With Myocardial Perfusion in Patients With ST Elevation Myocardial Infarction Treated by Primary Per Cutaneous Coronary Intervention
An observational study of ST Elevation Myocardial Infarction, run by Assiut University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ST Elevation Myocardial Infarction
- What is being tested?
- ECG
- How many people
- 235 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2018to Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- Non-ST elevation myocardial infarction, prior history of myocardial infarction or surgical revascularization,
- Electrolyte disturbance.
- history of medications that may affect QT (anti-arrhythmic, anti-psychotic, and anti-depressant drugs),
- patients with cardiogenic shock or needing IABP.
- patients with previous CABG.
- Patients with implantable devices and pacemakers.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut university
Asyut, 71641
Marina Samir, master, 01204836349, morajesus24@outlook.com
Hossam El-Araby
About this study
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
- Conditions
- ST Elevation Myocardial Infarction
- Being tested
- ECG
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECGDiagnostic test
Also called Primary Percutaneous coronary intervention
Primary Percutaneous coronary intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study startJul 2018 (estimated)
- Primary completionJul 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 235 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MS Roshdy, Assiut University
- Investigators
- Hatem Helmy, Study chair, assistant professorHosam Hasan, Study chair, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03269838
- Sponsor's protocol ID
- 17100310
- Status last verified
- Jun 2018
- First submitted
- 27 Aug 2017
- Last updated
- 3 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of QT Dispersion With Myocardial Perfusion in Patients With ST Elevation Myocardial Infarction Treated by Primary Per Cutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT03269838
- Acronym / sponsor ID
- 17100310
- Conditions
- ST Elevation Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 235 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jul 2018 (estimated)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 1 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (6 listed)
- Non-ST elevation myocardial infarction, prior history of myocardial infarction or surgical revascularization,
- Electrolyte disturbance.
- history of medications that may affect QT (anti-arrhythmic, anti-psychotic, and anti-depressant drugs),
- patients with cardiogenic shock or needing IABP.
- patients with previous CABG.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECGAlso: Primary Percutaneous coronary interventionPrimary Percutaneous coronary intervention | Diagnostic test | – |
Primary outcome
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.
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
- Background: PubMed 26166018Karahan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hatem Helmy study chair
assistant professor
Hosam Hasan study chair
professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ST Elevation Myocardial Infarction, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marina Samir, master (01204836349, morajesus24@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of QT dispersion on 12-lead surface ECG with myocardial reperfusion (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03269838, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2018.