Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06177860
Status:
RECRUITING
Last Update Posted:
2024-01-05
First Post:
2023-11-29
Brief Title:
Clinical and Atherosclerotic Characteristics of Patients With ACS Associated With Cocaine Use
Sponsor:
Hospital El Cruce
Organization:
Hospital El Cruce
Study Overview
Official Title:
Clinical Presentation Coronary Angiographic Findings and Extent of Atherosclerotic Disease in Patients With Acute Coronary Syndrome Associated With Cocaine Use
Status:
RECRUITING
Status Verified Date:
2024-01
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:
Cocaine use has increased in our country in recent decades It is associated with cardiovascular events and early atherosclerotic disease Acute coronary syndrome ACS is one of its most frequent and serious manifestations There is a lack of scientific information on ACS associated with acute and chronic cocaine use in Argentina
This study aims to describe the socioeconomic clinical and coronary angiographic characteristics as well as the extent of atherosclerotic disease in patients with ACS associated with cocaine use and to compare them with ACS not associated with cocaine use
Methods We propose an observational analytical single-center two-phase study with a retrospective and a prospective component Patients with a diagnosis of ACS admitted to the coronary care unit of a high-complexity public hospital will be included Clinical biochemical coronary angiographic extracoronary atherosclerotic disease extension and prognostic variables will be described These variables will be compared between patients with cocaine-associated ACS and non-cocaine-associated ACS
This study aims to describe the socioeconomic clinical and coronary angiographic characteristics as well as the extent of atherosclerotic disease in patients with ACS associated with cocaine use and to compare them with ACS not associated with cocaine use
Methods We propose an observational analytical single-center two-phase study with a retrospective and a prospective component Patients with a diagnosis of ACS admitted to the coronary care unit of a high-complexity public hospital will be included Clinical biochemical coronary angiographic extracoronary atherosclerotic disease extension and prognostic variables will be described These variables will be compared between patients with cocaine-associated ACS and non-cocaine-associated ACS
Detailed Description:
General objective
- To identify socioeconomic clinical electrocardiographic coronary angiographic and atherosclerotic disease extent differences between ACS patients with a history of cocaine use and those without cocaine use
Specific objectives
To characterize and compare between both groups
Clinical characteristics
Coronary angiographic findings
Extent of myocardial damage related and unrelated to ACS
Severe complications during hospitalization mortality resuscitated cardiac arrest arrhythmias use of IV inotropics and mechanical ventilatory support
Extent of noncoronary vascular disease
Design
A quantitative approach will be used with an observational analytical single-center two-stage design In the retrospective stage cases admitted from April 2019 to June 2023 for ACS will be included based on data collected in the routine practice of the coronary care unit In the prospective stage all cases admitted to our institution for ACS from November 1 2023 to November 2024 will be included
Inclusion criteria
Age 18 years
Hospitalization with a diagnosis of ACS For the prospective stage acceptance to participate in the study and informed consent will be added
Exclusion criteria
Retrospective stage patients who were not questioned about cocaine use Prospective stage patients who could not be interviewed to determine their history of cocaine use because of their clinical condition
Procedures
Two groups will be defined according to the history of cocaine use cocaine-associated ACS and non-cocaine-associated ACS
For the retrospective phase all patients admitted to the coronary unit for ACS in the period established for the study will be reviewed It is standard practice to ask about cardiovascular risk factors history of substance use including cocaine and other clinical history We expect to correctly identify cases of ACS associated and not associated with cocaine use
In all cases included in both stages the clinical electrocardiographic biochemical and coronary angiographic characteristics and the extent of extra coronary atherosclerotic disease complications and prognosis will be described and compared between the two groups
In the prospective phase of the study where medically necessary cardiac magnetic resonance imaging MRI will be performed to assess the extent of ACS-related and non-ACS-related myocardial necrosis and edema Cardiac MRI findings will be compared between groups
Clinical follow-up will be limited to hospitalization
Main study variables and measurement instruments
- ACS associated with cocaine and other substance use They will be revealed by questioning following evidence-based recommendations ACS associated with cocaine use will be considered for those patients who verbally report the history
Clinical variables Will be recorded on admission age weight and height blood pressure heart rate cardiovascular risk factors hypertension diabetes dyslipidemia smoking use of other substances marijuana using the same criteria as for cocaine cardiovascular history myocardial infarction stroke coronary revascularization peripheral vascular disease and heart failure
Electrocardiographic variables 12-lead electrocardiograms will be performed on admission and during hospitalization to classify ACS as ST-elevation myocardial infarction STEMI or non-ST-elevation acute coronary syndrome NSTEMI to describe the location of ACS and to detect complications
Biochemical a general and specific biochemical evaluation of ACS CPK CK mb troponin Pro BNP will be performed Peak enzymatic elevation of CPK and troponins will be used as a biochemical indicator of the extent of myocardial necrosis
Echocardiography an assessment of ventricular function will be performed by measuring ejection fraction diastolic dysfunction and wall motility disorders The presence of mechanical complications will be evaluated by this method
Extent and complexity of coronary atherosclerotic disease coronary angiography will be used to define the extent and complexity of coronary lesions using the SYNTAX score Also an assessment of acute pathophysiological mechanisms related to ACS thrombus spasm coronary dissection as dichotomous variables present or absent will be performed
Extent of extra coronary atherosclerotic disease ankle-brachial index ABI will be used as an indicator of peripheral vascular disease of the lower limbs The presence morphology and extent of atherosclerotic plaque at the carotid level will be determined by carotid Doppler ultrasound
MRI the degree of myocardial necrosis and edema related and unrelated to ACS will be assessed as a manifestation of acute and chronic myocardial damage associated with ACS and cocaine use
Statistical analysis
Continuous variables will be described as mean and standard deviation in the case of normal distribution or median and interquartile range and categorical variables will be described as numbers and percentages Differences between groups for continuous variables will be evaluated with the T-test for variables with a normal distribution and the Kruskal-Wallis test for nonparametric variables Categorical variables will be compared using the chi-squared test and Fishers exact test Multiple logistic regression models will be developed to determine the independent association between cocaine use and the dependent variables of interest Statistical analysis will be performed with the R Studio program
Procedures to ensure the ethical aspects of the research
All study procedures will be conducted following international ethical norms and standards to respect participants rights and protect confidentiality
In addition all study procedures conform to the principles of the Declaration of Helsinki and CIOMS guidelines
The research protocol was submitted for evaluation and approved by the Research Ethics Committee REC of the El Cruce Hospital
For the retrospective stage the research team will make every effort to contact patients who meet the inclusion criteria to request informed consent for their data to be analyzed undertaking to guarantee the anonymity of personal data For the prospective stage of the study potentially eligible individuals will receive a detailed explanation of the objectives and procedures before enrollment They will be asked to sign the informed consent form ICF Participation is voluntary and anonymity and confidentiality of information are compromised At this stage only cases that have signed the ICF will be included
All information related to the study will be securely archived with access codes only available to the research team Personal identification records will be kept separately from study records identified by code number Data collection forms will be coded to maintain participant confidentiality The local database will be protected with a password-protected access system Study key codes linking participant identification numbers to other identifying information will be stored in a separate locked file in a limited access area
- To identify socioeconomic clinical electrocardiographic coronary angiographic and atherosclerotic disease extent differences between ACS patients with a history of cocaine use and those without cocaine use
Specific objectives
To characterize and compare between both groups
Clinical characteristics
Coronary angiographic findings
Extent of myocardial damage related and unrelated to ACS
Severe complications during hospitalization mortality resuscitated cardiac arrest arrhythmias use of IV inotropics and mechanical ventilatory support
Extent of noncoronary vascular disease
Design
A quantitative approach will be used with an observational analytical single-center two-stage design In the retrospective stage cases admitted from April 2019 to June 2023 for ACS will be included based on data collected in the routine practice of the coronary care unit In the prospective stage all cases admitted to our institution for ACS from November 1 2023 to November 2024 will be included
Inclusion criteria
Age 18 years
Hospitalization with a diagnosis of ACS For the prospective stage acceptance to participate in the study and informed consent will be added
Exclusion criteria
Retrospective stage patients who were not questioned about cocaine use Prospective stage patients who could not be interviewed to determine their history of cocaine use because of their clinical condition
Procedures
Two groups will be defined according to the history of cocaine use cocaine-associated ACS and non-cocaine-associated ACS
For the retrospective phase all patients admitted to the coronary unit for ACS in the period established for the study will be reviewed It is standard practice to ask about cardiovascular risk factors history of substance use including cocaine and other clinical history We expect to correctly identify cases of ACS associated and not associated with cocaine use
In all cases included in both stages the clinical electrocardiographic biochemical and coronary angiographic characteristics and the extent of extra coronary atherosclerotic disease complications and prognosis will be described and compared between the two groups
In the prospective phase of the study where medically necessary cardiac magnetic resonance imaging MRI will be performed to assess the extent of ACS-related and non-ACS-related myocardial necrosis and edema Cardiac MRI findings will be compared between groups
Clinical follow-up will be limited to hospitalization
Main study variables and measurement instruments
- ACS associated with cocaine and other substance use They will be revealed by questioning following evidence-based recommendations ACS associated with cocaine use will be considered for those patients who verbally report the history
Clinical variables Will be recorded on admission age weight and height blood pressure heart rate cardiovascular risk factors hypertension diabetes dyslipidemia smoking use of other substances marijuana using the same criteria as for cocaine cardiovascular history myocardial infarction stroke coronary revascularization peripheral vascular disease and heart failure
Electrocardiographic variables 12-lead electrocardiograms will be performed on admission and during hospitalization to classify ACS as ST-elevation myocardial infarction STEMI or non-ST-elevation acute coronary syndrome NSTEMI to describe the location of ACS and to detect complications
Biochemical a general and specific biochemical evaluation of ACS CPK CK mb troponin Pro BNP will be performed Peak enzymatic elevation of CPK and troponins will be used as a biochemical indicator of the extent of myocardial necrosis
Echocardiography an assessment of ventricular function will be performed by measuring ejection fraction diastolic dysfunction and wall motility disorders The presence of mechanical complications will be evaluated by this method
Extent and complexity of coronary atherosclerotic disease coronary angiography will be used to define the extent and complexity of coronary lesions using the SYNTAX score Also an assessment of acute pathophysiological mechanisms related to ACS thrombus spasm coronary dissection as dichotomous variables present or absent will be performed
Extent of extra coronary atherosclerotic disease ankle-brachial index ABI will be used as an indicator of peripheral vascular disease of the lower limbs The presence morphology and extent of atherosclerotic plaque at the carotid level will be determined by carotid Doppler ultrasound
MRI the degree of myocardial necrosis and edema related and unrelated to ACS will be assessed as a manifestation of acute and chronic myocardial damage associated with ACS and cocaine use
Statistical analysis
Continuous variables will be described as mean and standard deviation in the case of normal distribution or median and interquartile range and categorical variables will be described as numbers and percentages Differences between groups for continuous variables will be evaluated with the T-test for variables with a normal distribution and the Kruskal-Wallis test for nonparametric variables Categorical variables will be compared using the chi-squared test and Fishers exact test Multiple logistic regression models will be developed to determine the independent association between cocaine use and the dependent variables of interest Statistical analysis will be performed with the R Studio program
Procedures to ensure the ethical aspects of the research
All study procedures will be conducted following international ethical norms and standards to respect participants rights and protect confidentiality
In addition all study procedures conform to the principles of the Declaration of Helsinki and CIOMS guidelines
The research protocol was submitted for evaluation and approved by the Research Ethics Committee REC of the El Cruce Hospital
For the retrospective stage the research team will make every effort to contact patients who meet the inclusion criteria to request informed consent for their data to be analyzed undertaking to guarantee the anonymity of personal data For the prospective stage of the study potentially eligible individuals will receive a detailed explanation of the objectives and procedures before enrollment They will be asked to sign the informed consent form ICF Participation is voluntary and anonymity and confidentiality of information are compromised At this stage only cases that have signed the ICF will be included
All information related to the study will be securely archived with access codes only available to the research team Personal identification records will be kept separately from study records identified by code number Data collection forms will be coded to maintain participant confidentiality The local database will be protected with a password-protected access system Study key codes linking participant identification numbers to other identifying information will be stored in a separate locked file in a limited access area
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None