Myocardial Infarction Clinical Trial
Official title:
Clinical Presentation, Coronary Angiographic Findings and Extent of Atherosclerotic Disease in Patients With Acute Coronary Syndrome Associated With Cocaine Use
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.
Status | Recruiting |
Enrollment | 400 |
Est. completion date | November 30, 2024 |
Est. primary completion date | November 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Argentina | Hospital El Cruce | Florencio Varela | Buenos Aires |
Lead Sponsor | Collaborator |
---|---|
Hospital El Cruce |
Argentina,
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US Preventive Services Task Force; Krist AH, Davidson KW, Mangione CM, Barry MJ, Cabana M, Caughey AB, Curry SJ, Donahue K, Doubeni CA, Epling JW Jr, Kubik M, Ogedegbe G, Pbert L, Silverstein M, Simon MA, Tseng CW, Wong JB. Screening for Unhealthy Drug Us — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Clinical presentation as STEAMI, or NSTEAMI or unstable angina | Differences between groups in clinical presentation as STEAMI, NSTEAMI 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 | |
Primary | Mortality | Total mortality | During hospitalization (up to 30 days) | |
Primary | 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 | 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) | |
Secondary | Myocardial damage | The extent of ischemic and non-ischemic myocardial damage will be quantified by cardiac MRI. | During hospitalization (up to 30 days) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) |
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