Clinical Presentation, Coronary Angiographic Findings and Extent of Atherosclerotic Disease in Patients With Acute Coronary Syndrome Associated With Cocaine Use
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patients who, due to their clinical condition, cannot be interviewed to determine their history of cocaine use.
结局指标
主要结局
Mortality
时间窗: During hospitalization (up to 30 days)
Total mortality
Severe complications
时间窗: During hospitalization (up to 30 days)
A combined ouctome including: resuscitated cardiac arrest, complex arrhythmia requiring electrical cardioversion, use of inotropes, or mechanical ventilatory support.
Clinical presentation as STEAMI, or NSTEAMI or unstable angina
时间窗: Up to 24 hours of admission
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.
Complexity and extent of coronary heart disease
时间窗: During coronary angiography
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.
次要结局
- Myocardial damage(During hospitalization (up to 30 days))
- Socioeconomic factors: highest level of formal education(During hospitalization (up to 30 days))
- Extent of atherosclerotic vascular disease(During hospitalization (up to 30 days))
- Socioeconomic factors: unemployment(During hospitalization (up to 30 days))
- Socioeconomic factors: health insurance(During hospitalization (up to 30 days))
研究者
Maximiliano de Abreu
Principal Investigator
Hospital El Cruce