Ignite Creation Date:
2024-05-06 @ 6:15 PM
Last Modification Date:
2024-10-26 @ 2:45 PM
Study NCT ID:
NCT05605106
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-11-04
First Post:
2022-10-28
Brief Title:
Addiction and Acute Coronary Syndrome
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Addiction and Correlation With in Hospital Outcomes of Patients Presenting With Acute Coronary Syndrome Regarding to TIMI Flow and LV Function
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 detect the effect of duration of addiction on myocardial infarction lesion and outcomes of pci
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
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 Gpower software 3192 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 groupsaddict and non addict patients
Main statistical test is independant t-test to detect the difference between the 2 groups Alpha 005 Power 090 Effect size 07
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 005
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 Gpower software 3192 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 groupsaddict and non addict patients
Main statistical test is independant t-test to detect the difference between the 2 groups Alpha 005 Power 090 Effect size 07
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 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None