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Acute Coronary SyndromeNCT05605106

Addiction and Acute Coronary Syndrome

An observational study of Acute Coronary Syndrome and Addiction, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Mina Zaky, resident contact

+201270880164

gafeet90@gmail.com

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

  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. 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

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 groups in NCT05605106
Study groupRoleWhat they receive
addict patients presenting with acute coronary syndromeNot described
Receives: Diagnostic Test: speckle tracking echocardiography; Procedure: Percutaneous coronary intervention
non addict patients presenting with acute coronary syndromeNot 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.

  1. 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

  2. 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.

  1. First posted4 Nov 2022
  2. Study start1 Dec 2022 (estimated)
  3. Primary completion1 Dec 2024 (estimated)
  4. Study completion1 Feb 2025 (estimated)

Resources

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)
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

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.

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