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临床试验/NCT05246683
NCT05246683Unknown不适用

LATIN SHOCK: Registro Latinoamericano de Shock Cardiogénico en el Contexto de Los Sindromes Coronarios Agudos

Sociedad Argentina de Cardiología1 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2022年2月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
700
试验地点
1
主要终点
Register through the survey modality the incidence of the clinical characteristics of the patients admitted to the coronary unit with acute coronary syndromes and cardiogenic shock, either from admission or during its in-hospital evolution.

研究概览

简要总结

This is a Registry of the characteristics and clinical evolution of patients admitted for acute coronary syndromes (with or without st segment elevation) who present with cardiogenic shock or develop it during the hospitalization period.

Cardiogenic shock is a rare pathology, but it constitutes the leading cause of mortality in patients hospitalized for acute infarction myocardium. Its incidence ranges between 7 and 10% of the cases of infarction1 and is associated with a mortality of 40-50% despite revascularization and the use of Intra-Aortic Counterpulsation Balloon. Most of the bibliography on this subject is North American and has a lot of years and the one currently published shows mostly the results of different ventricular supports that are not used routinely in our countries. So far there is no record that reports the reality of Latin America. Only in Argentina, a registry has been carried out (Re Na Shock) but more than 5 years have passed since its publication. In the last years have even changed the management guidelines for this pathology and have been published works that could have changed previous behaviors

. This is a project of the Argentine Society of Cardiology to collect data epidemiological and current management of cardiogenic shock in Latin America.

详细描述

It is an international, multicenter, observational registry of prospective and consecutive patients with cardiogenic shock in the context of acute coronary syndromes, which will last 12 months from its start on December 4, 2021. Coronary Units will be invited to participate from different Latin American countries through the different cardiology societies. It will be assigned to each country and each participant center a number and patients will be entered into the registry in correlative order by center (1-2-3-etc) to maintain the confidentiality of the patients data. Since the patient data will be extracted from the medical records, the records will be anonymous and there will be no follow-up, no informed consent is required. The names of the participating centers of the different countries will appear in a list at the end of the publications, under the collective name of "LATIN Shock group".

Definition of cardiogenic shock (classic): presence of systolic blood pressure

≤ 90 mm Hg for 30 minutes or requirement of vasopressors, inotropics and / or ventricular supports to maintain a blood pressure ≥ 90 mm Hg, associated with signs of hypoperfusion and pulmonary congestion, in the absence of hypovolemia or arrhythmias that justify the clinical picture. A new definition of cardiogenic shock has recently been proposed (SCAI), which includes 5 categories. In this work, patients with cardiogenic shock only those with C, D and E letter will be included.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients of both sexes and older than 18 years, admitted to the unit coronary or polyvalent critical care, for an acute coronary syndrome with or without ST-segment elevation presenting cardiogenic shock from the admission or develop it during the hospitalization and that can be followed in its evolution until hospital discharge. -

排除标准

  • Non-ischemic cardiogenic shock (chronic heart failure, myocarditis, sepsis, tachycardiomyopathies, Takotsubo, etc.). Cardiogenic shock A and B of the new SCAI classification

结局指标

主要结局

Register through the survey modality the incidence of the clinical characteristics of the patients admitted to the coronary unit with acute coronary syndromes and cardiogenic shock, either from admission or during its in-hospital evolution.

时间窗: 1 year

characteristics

To analyze the treatment and diagnostics methods of patients with cardiogenic shock during hospital stay.

时间窗: 1 year

treatment

Observe in-hospital clinical evolution and incidence of complications of patients with cardiogenic shock.

时间窗: 1 year

evolution

次要结局

  • Find predictors of in-hospital mortality.(1 year)
  • To compare the clinical, management and evolution characteristics in the different participating Latin American countries.(1 year)

研究者

发起方
Sociedad Argentina de Cardiología
申办方类型
Other
责任方
Sponsor

研究点 (1)

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