Acute Coronary SyndromeNCT05605106
Addiction and Acute Coronary Syndrome
An observational study of Acute Coronary Syndrome and Addiction, run by Assiut University.
Trial summary
the study aims to 1. identify the effect of addiction on TIMI flow in patients presented with acute coronary syndrome. 2. identify the effect of addiction on outcomes of medical treatment of patients presenting with acute coronary syndrome. 3. identify the relation between addiction and LV function. 4. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Coronary Syndrome, Addiction
- What is being tested?
- speckle tracking echocardiography and Percutaneous coronary intervention
- Type of treatment
- Surgery or procedure
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2022to 1 Feb 2025
- 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: The study will include all patients presented with acute coronary syndrome in Assuit University Hospital .
Who may be able to join
- All patients of all categories of ages who will be presented with acute coronary syndrome in Assuit University Hospital .
Who cannot join
- Pateints presented with cardiogenic shock
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Addiction and Correlation With in Hospital Outcomes of Patients Presenting With Acute Coronary Syndrome Regarding to TIMI Flow and LV Function
the study aims to
- identify the effect of addiction on TIMI flow in patients presented with acute coronary syndrome.
- identify the effect of addiction on outcomes of medical treatment of patients presenting with acute coronary syndrome.
- identify the relation between addiction and LV function.
- detect the effect of duration of addiction on myocardial infarction lesion and outcomes of pci.
Read the detailed description
substance abuse has been increasing nationally, yet its potential cardiovascular consequences are not fully understood.
There are limited data on the true prevalence of substance abuse in individuals who experience a myocardial infarction .
myocardial infarction is one of the most common diseases with high mortality and morbidity in human beings. There are many known risk factors in Coronary Artery Disease like; old age, male gender, cigarette smoking, hypertension, diabetes mellitus and hyperlipidemia .
Though, few studies have investigated the effect of addiction on coronary artery disease. Some studies reported harmful effects of addiction including opioid ,cocaine ,amphetamine and marijuana on the cardiovascular system . Some other studies did not find any association between drug addiction and coronary artery disease .
Thrombolysis in Myocardial Infarction (TIMI) coronary grade flow is an established, validated score to assess the epicardial perfusion on coronary angiography. TIMI flow grade 0 represents total occlusion, while TIMI flow grade 3 represents normal epicardial perfusion . Previous studies have demonstrated that patients with low grade TIMI flow prior to percutaneous coronary intervention (PCI) have a less favorable outcome. Preprocedural TIMI flow has been found to be an independent predictor of survival in patients with acute myocardial infarction , and has also been shown to predict final infarct size .
In the past decade, a new echocardiographic technique known as strain has been used to make more accurate assessments of the contractile state of the heart. Strain echocardiography has been used in a wide range of cardiovascular conditions including HF and acute coronary syndromes .Unlike conventional techniques of determining systolic function that rely on visual assessment of wall motion and changes in volume, strain echocardiography measures actual tissue deformation within the myocardium. Conceptually, strain can be thought of as a way to determine the movement between two points as if those two points are connected by a string. The physical definition of strain is the relative change in length of a material related to its original length.
Speckle tracking is a recent development in image processing that uses proprietary software to automatically determine the movements of these points, which appear sonographically as "speckles," within the myocardium over time. Tracking the movements of these speckles throughout the cardiac cycle yields positive values when the two points are moving away from one another, as in diastole, and negative values when they are moving towards one another, as in systole. Speckle tracking obviates the need for Doppler-based imaging technologies to calculate strain, which have proved to be challenging due to their angle-dependency .
LV strain on 2D echocardiography has been well studied in patients with ACS. For patients with ST-segment elevation MI , LV strain has been shown to be an important predictor of post-discharge adverse outcomes. .LV strain can also help discriminate which patients will successfully recover LV function and which patients will develop adverse LV remodeling .Moreover, decreased LV strain within 24 hours of revascularization for acute MI can reliably predict which patients are more likely to achieve a composite end-point of any of the following: all-cause mortality, hospitalization with re-infarction, HF, or stroke at six-month follow up.
Sample size:
Based on determining the main outcome variable, the estimated minimum required sample size is 72 patients (36 patient in each group) .
The sample was calculated using G*power software 3.1.9.2., based on the following assumptions: Main outcome variable is the difference between mean value of MACE rate ( major adverse cardiovascular event) in addict patients undergoing PCI ( percutaneous coronary intervention ) .
Based on clinical experience we expected to find medium effect size difference between 2 groups(addict and non addict patients).
Main statistical test is independant t-test to detect the difference between the 2 groups Alpha = 0.05 Power = 0.90 Effect size = 0.7
Statistical analysis:
Data entry and analysis will be carried out using SPSS version 20. Descriptive statistics will be done, and then analytical statistics will be chosen according to the type of variables. Values will be considered significant when P values less than 0.05
- Conditions
- Acute Coronary Syndrome, Addiction
- Being tested
- speckle tracking echocardiography, Percutaneous coronary intervention
- Medical subject headings
- Acute Coronary Syndrome, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
speckle tracking echocardiographyDiagnostic test
Speckle tracking is a recent development in image processing that uses proprietary software to automatically determine the movements of these points, which appear sonographically as "speckles," within the myocardium over time. Tracking the movements of these speckles throughout the cardiac cycle yields positive values when the two points are moving away from one another, as in diastole, and negative values when they are moving towards one another, as in systole
Percutaneous coronary interventionProcedure or surgery
Percutaneous coronary intervention refers to a family of minimally invasive procedures used to open clogged coronary arteries (those that deliver blood to the heart). By restoring blood flow, the treatment can improve symptoms of blocked arteries, such as chest pain or shortness of breath.
| Study group | Role | What they receive |
|---|---|---|
| addict patients presenting with acute coronary syndrome | Not described Receives: Diagnostic Test: speckle tracking echocardiography; Procedure: Percutaneous coronary intervention | |
| non addict patients presenting with acute coronary syndrome | Not described Receives: Diagnostic Test: speckle tracking echocardiography; Procedure: Percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular systolic dysfunction in patients presenting with acute coronary syndrome
Left ventricular systolic dysfunction is a common and serious complication of acute coronary syndrome that leads to increased risks of sudden death and of heart failure .
in this study it will be measured using speckle tracking echocardiography.
Measured: baseline
Thrombolysis in Myocardial Infarction (TIMI) in patients undergoing PCI
The TIMI Coronary Grade Flow is an effective and well-studied grading system of coronary reperfusion on an angiogram.
Grade 0 means complete occlusion of the infarct-related artery Grade 1 means some penetration of contrast material beyond the point of obstruction but without perfusion of the distal coronary bed Grade 2 means perfusion of the entire infarct vessel into the distal bed but with delayed flow compared with a normal artery Grade 3 means full perfusion of the infarct vessel with normal flow
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start1 Dec 2022 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Amir Zaky Habib, Assiut University
- Investigators
- Hossam El Araby, professor, Principal investigatorSalma Taha, doctor, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05605106
- Sponsor's protocol ID
- addict ACS pts
- Status last verified
- Oct 2022
- First submitted
- 28 Oct 2022
- Last updated
- 4 Nov 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addiction and Correlation With in Hospital Outcomes of Patients Presenting With Acute Coronary Syndrome Regarding to TIMI Flow and LV Function
- ClinicalTrials.gov ID
- NCT05605106
- Acronym / sponsor ID
- addict ACS pts
- Conditions
- Acute Coronary Syndrome, Addiction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 4 Nov 2022 (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.
the study aims to
- identify the effect of addiction on TIMI flow in patients presented with acute coronary syndrome.
- identify the effect of addiction on outcomes of medical treatment of patients presenting with acute coronary syndrome.
- identify the relation between addiction and LV function.
- detect the effect of duration of addiction on myocardial infarction lesion and outcomes of pci.
Detailed description
substance abuse has been increasing nationally, yet its potential cardiovascular consequences are not fully understood.
There are limited data on the true prevalence of substance abuse in individuals who experience a myocardial infarction .
myocardial infarction is one of the most common diseases with high mortality and morbidity in human beings. There are many known risk factors in Coronary Artery Disease like; old age, male gender, cigarette smoking, hypertension, diabetes mellitus and hyperlipidemia .
Though, few studies have investigated the effect of addiction on coronary artery disease. Some studies reported harmful effects of addiction including opioid ,cocaine ,amphetamine and marijuana on the cardiovascular system . Some other studies did not find any association between drug addiction and coronary artery disease .
Thrombolysis in Myocardial Infarction (TIMI) coronary grade flow is an established, validated score to assess the epicardial perfusion on coronary angiography. TIMI flow grade 0 represents total occlusion, while TIMI flow grade 3 represents normal epicardial perfusion . Previous studies have demonstrated that patients with low grade TIMI flow prior to percutaneous coronary intervention (PCI) have a less favorable outcome. Preprocedural TIMI flow has been found to be an independent predictor of survival in patients with acute myocardial infarction , and has also been shown to predict final infarct size .
In the past decade, a new echocardiographic technique known as strain has been used to make more accurate assessments of the contractile state of the heart. Strain echocardiography has been used in a wide range of cardiovascular conditions including HF and acute coronary syndromes .Unlike conventional techniques of determining systolic function that rely on visual assessment of wall motion and changes in volume, strain echocardiography measures actual tissue deformation within the myocardium. Conceptually, strain can be thought of as a way to determine the movement between two points as if those two points are connected by a string. The physical definition of strain is the relative change in length of a material related to its original length.
Speckle tracking is a recent development in image processing that uses proprietary software to automatically determine the movements of these points, which appear sonographically as "speckles," within the myocardium over time. Tracking the movements of these speckles throughout the cardiac cycle yields positive values when the two points are moving away from one another, as in diastole, and negative values when they are moving towards one another, as in systole. Speckle tracking obviates the need for Doppler-based imaging technologies to calculate strain, which have proved to be challenging due to their angle-dependency .
LV strain on 2D echocardiography has been well studied in patients with ACS. For patients with ST-segment elevation MI , LV strain has been shown to be an important predictor of post-discharge adverse outcomes. .LV strain can also help discriminate which patients will successfully recover LV function and which patients will develop adverse LV remodeling .Moreover, decreased LV strain within 24 hours of revascularization for acute MI can reliably predict which patients are more likely to achieve a composite end-point of any of the following: all-cause mortality, hospitalization with re-infarction, HF, or stroke at six-month follow up.
Sample size:
Based on determining the main outcome variable, the estimated minimum required sample size is 72 patients (36 patient in each group) .
The sample was calculated using G*power software 3.1.9.2., based on the following assumptions: Main outcome variable is the difference between mean value of MACE rate ( major adverse cardiovascular event) in addict patients undergoing PCI ( percutaneous coronary intervention ) .
Based on clinical experience we expected to find medium effect size difference between 2 groups(addict and non addict patients).
Main statistical test is independant t-test to detect the difference between the 2 groups Alpha = 0.05 Power = 0.90 Effect size = 0.7
Statistical analysis:
Data entry and analysis will be carried out using SPSS version 20. Descriptive statistics will be done, and then analytical statistics will be chosen according to the type of variables. Values will be considered significant when P values less than 0.05
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| addict patients presenting with acute coronary syndrome | – | Diagnostic Test: speckle tracking echocardiography, Procedure: Percutaneous coronary intervention |
| non addict patients presenting with acute coronary syndrome | – | Diagnostic Test: speckle tracking echocardiography, Procedure: Percutaneous coronary intervention |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The study will include all patients presented with acute coronary syndrome in Assuit University Hospital .
Key inclusion criteria (1 listed)
- All patients of all categories of ages who will be presented with acute coronary syndrome in Assuit University Hospital .
Key exclusion criteria (1 listed)
- Pateints presented with cardiogenic shock
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 |
|---|---|---|
| speckle tracking echocardiographySpeckle tracking is a recent development in image processing that uses proprietary software to automatically determine the movements of these points, which appear sonographically as "speckles," within the myocardium over time. Tracking the movements of these speckles throughout the cardiac cycle yields positive values when the two points are moving away from one another, as in diastole, and negative values when they are moving towards one another, as in systole | Diagnostic test | addict patients presenting with acute coronary syndrome, non addict patients presenting with acute coronary syndrome |
| Percutaneous coronary interventionPercutaneous coronary intervention refers to a family of minimally invasive procedures used to open clogged coronary arteries (those that deliver blood to the heart). By restoring blood flow, the treatment can improve symptoms of blocked arteries, such as chest pain or shortness of breath. | Procedure or surgery | addict patients presenting with acute coronary syndrome, non addict patients presenting with acute coronary syndrome |
Primary outcome
Left ventricular systolic dysfunction in patients presenting with acute coronary syndrome
Time frame: baseline
Left ventricular systolic dysfunction is a common and serious complication of acute coronary syndrome that leads to increased risks of sudden death and of heart failure . in this study it will be measured using speckle tracking echocardiography.
Thrombolysis in Myocardial Infarction (TIMI) in patients undergoing PCI
Time frame: baseline
The TIMI Coronary Grade Flow is an effective and well-studied grading system of coronary reperfusion on an angiogram. Grade 0 means complete occlusion of the infarct-related artery Grade 1 means some penetration of contrast material beyond the point of obstruction but without perfusion of the distal coronary bed Grade 2 means perfusion of the entire infarct vessel into the distal bed but with delayed flow compared with a normal artery Grade 3 means full perfusion of the infarct vessel with normal flow
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
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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.
Hossam El Araby, professor principal investigator
Salma Taha, doctor principal investigator
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome and Addiction, run by Assiut University.
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 1 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 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Mina Zaky, resident (+201270880164, gafeet90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular systolic dysfunction in patients presenting with acute coronary syndrome (time frame: baseline). 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?
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 4 Nov 2022; AzTrials last refreshed its copy on 6 Nov 2026.