Clinical and Atherosclerotic Characteristics of Patients With ACS Associated With Cocaine Use

Study Overview
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Brief Summary
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Cocaine consumption has increased in our country in recent decades, and is associated with an increase in cardiovascular events and early atherosclerotic disease. Acute coronary syndrome (ACS) is one of its most frequent and serious manifestations. There is little scientific information about ACS associated with acute and chronic cocaine use in Argentina. The objective of the study is to describe the socioeconomic, clinical, and coronary angiographic characteristics, and the extent of atherosclerotic disease of patients with ACS associated with cocaine use, and compare them with ACS non-associated with cocaine use. Methods: An observational, analytical, single-center, two-stage study is proposed, with a retrospective and a prospective component. Patients with a diagnosis of ACS admitted to the coronary unit in a high-complexity public hospital will be included. Baseline and evolutionary clinical, biochemical, coronary angiographic, extension of extra coronary atherosclerotic disease, and prognostic variables will be assessed. These variables will be compared between patients with ACS associated with cocaine use and those not associated.

Detailed Description
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General objective: - Identify the socioeconomic, clinical, electrocardiographic, and angiographic differences between patients with ACS who report a history of cocaine use and patients with ACS who do not report cocaine use. Specific objectives: To characterize and compare between groups: Clinical characteristics and coronary angiographic findings. Extension of myocardial damage related and unrelated to ACS. Severe complications during the hospitalization (mortality, resuscitated cardiac arrest, arrhythmias, use of IV inotropics, and mechanical ventilatory support). Extent of non-coronary vascular disease. Design: A quantitative approach will be used, with an observational, prospective, 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 service's usual practice. In the prospective stage, all cases admitted to our institution due to ACS from November 1, 2023, to November 2024 will be included. Inclusion criteria: Age equal to or greater than 18 years. Hospitalization with a diagnosis of ACS, made by the treating medical team. For the prospective stage, it will be added: - Acceptance to participate in the study and willingness to sign the informed consent. Exclusion Criteria: Retrospective stage: - Patients who have not been questioned about cocaine use. Prospective stage: - Patients who, due to their clinical condition, cannot be interviewed to determine their history of cocaine use. Procedures: Two groups will be defined according to the history of cocaine use: SCA associated with cocaine use and non-associated SCA. For the retrospective stage, the data recorded will be reviewed for all patients who were admitted to the coronary unit for ACS in the period established by the study. Considering that as a normal practice in the service, questions are asked about cardiovascular risk factors, history of substance use including cocaine, and other clinical history, it is expected to have the necessary information to identify cases of ACS associated and those not associated with consumption of cocaine. In all cases in both stages, the clinical, electrocardiographic, biochemical, coronary angiographic characteristics, extension of extra coronary atherosclerotic disease, complications, and prognosis between both groups will be described and compared. In the prospective stage, in cases where it is necessary according to medical criteria, cardiac magnetic resonance imaging (MRI) will be performed in order to assess the degree of myocardial necrosis and edema related and unrelated to the ACS. Cardiac MRI findings of both groups of patients will be compared. Clinical follow-up will be limited to hospitalization. Main variables of the study and measurement instruments associated with the use of cocaine and other substances: They will be revealed through questioning, following evidence-based recommendations. Patients who verbally report the history will be considered ACS associated with cocaine use. Clinical variables: The following will be recorded upon admission: age, weight and height, blood pressure, heart rate, cardiovascular risk factors (hypertension, diabetes, dyslipidemia, smoking), other substance use (marijuana, using the same criteria as for cocaine), cardiovascular history (myocardial infarction, stroke, coronary revascularization, peripheral vascular disease), presence of signs of heart failure. Electrocardiographic variables: 12-lead electrocardiograms will be performed on admission and during hospitalization, to classify the ACS as ST elevation myocardial infarction (STEMI) or non-ST elevation acute coronary syndrome (NSTEACS), describe the location of the ACS, and detect complications. Biochemical: general and specific biochemical assessment of ACS (CPK, CK mb, troponin, Pro BNP) will be performed. The peak enzymatic elevation of CPK and troponins will be used among other indicators of the extent of the myocardial infarction. Echocardiography: an assessment of ventricular function will be carried out through the measurement of ejection fraction, diastolic dysfunction, wall motility disorders, and mechanical complications. Extension and complexity of coronary atherosclerotic disease: coronary angiography will define, and the extension and complexity of the coronary lesions using the Syntax score. Likewise, an assessment of the acute pathophysiological mechanisms related to ACS (thrombus, spasm, coronary dissection, as dichotomous variables: present or absent) will be carried out. Extension of extra coronary atherosclerotic disease: Ankle-brachial index (ABI): ABI will be used as an indicator of peripheral vascular disease of the lower limbs. Carotid Doppler ultrasound: the presence, morphology, and extension of the atherosclerotic plaque at the carotid level will be determined. Cardiac magnetic resonance: the degree of myocardial necrosis and edema related and unrelated to the SCA will be assessed, as a manifestation of acute and chronic myocardial damage. Statistic 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 non-parametric variables. Categorical variables will be compared using the chi-square test and Fisher's exact test. Multiple logistic regression models will be developed to determine the independent association between cocaine use and dependent variables of interest. The statistical analysis will be carried out with the R Studio program. Procedures to guarantee the ethical aspects of the research: All study procedures will be carried out following international ethical regulations and standards through defined operating procedures to respect the rights of the participants and protect confidentiality. Furthermore, all study procedures are in accordance with the principles of the Declaration of Helsinki and CIOMS guidelines. The research protocol was subject to evaluation and approved by the Research Ethics Committee (CEI) of the El Cruce Hospital. For the retrospective stage, the research team makes every effort to contact the patients who meet the inclusion criteria to request informed consent for their data to be analyzed, committing to guarantee the anonymization of personal data. For the prospective stage of the study, potentially eligible people will be provided with a detailed explanation of the objectives and procedures before joining and will be asked to sign the informed consent (ICF). During the informed consent process, it will be explained to them that participation is voluntary and that the anonymity and confidentiality of the information are committed. 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. Records containing personal identification will be stored separately from study records identified by code number. Data collection forms will be coded to maintain the confidentiality of the participants. The local database will be protected with a password-protected access system. Key study codes that link participant identification numbers to other identifying information will be stored in a separate, locked file in an area with limited access.

Official Title
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Clinical Presentation, Coronary Angiographic Findings and Extent of Atherosclerotic Disease in Patients With Acute Coronary Syndrome Associated With Cocaine Use

Conditions
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Myocardial Infarction, Acute Coronary Syndrome, Cocaine Use, Cocaine Abuse

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 Hospitalization due to diagnosis of ACS, made by the treating medical team. For the prospective stage, it will be added: Acceptance to participate in the study and willingness to sign the informed consent. Exclusion Criteria: Patients who, due to their clinical condition, cannot be interviewed to determine their history of cocaine use.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complexity and extent of coronary heart disease | The Syntax Score (Synergy Between PCI With Taxus and Cardiac Surgery) will be quantified in patients with and without a history of cocaine use. A higher Syntax Score indicates a more complex coronary disease as well as worse prognosis. Score values of 0 to 22 are considered low complexity, 23 to 32 moderate complexity and >32 high complexity. | During coronary angiography | 
| Clinical presentation as STEIAM, or NSTEIAM or unstable angina | Differences between groups in clinical presentation as STEIAM, NSTEIAM or unstable angina will be based on the findings of the first electrocardiogram registred during admision, following the Fourth Universal Definition of Myocardial Infarction. | Up to 24 hours of admission | 
| Mortality | Total mortality | During hospitalization (up to 30 days) | 
| Severe complications | A combined ouctome including: resuscitated cardiac arrest, complex arrhythmia requiring electrical cardioversion, use of inotropes, or mechanical ventilatory support. | During hospitalization (up to 30 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extent of atherosclerotic vascular disease | The extent of extracoronary atherosclerotic vascular disease will be quantified by vascular Doppler of the carotids and lower limbs | During hospitalization (up to 30 days) | 
| Myocardial damage | The extent of ischemic and non-ischemic myocardial damage will be quantified by cardiac MRI. | During hospitalization (up to 30 days) | 
| Socioeconomic factors: unemployment | Unemployment (as a proportion) will be compared between patients with and without a history of cocaine use. | During hospitalization (up to 30 days) | 
| Socioeconomic factors: health insurance | Health insurance ownership (as a proportion) will be compared between patients with and without a history of cocaine use. | During hospitalization (up to 30 days) | 
| Socioeconomic factors: highest level of formal education | The highest level of formal education (as an ordinal variable from kindergarten = 1 to college = 8) will be compared between patients with and without a history of cocaine use. | During hospitalization (up to 30 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myocardial infarction, Acute Coronary Syndrome, Cocaine Use, Cocaine Abuse