跳至主要内容
临床试验/NCT02877251
NCT02877251尚未招募不适用

Mexican Multidisciplinary Registry of Patients With Venous Thromboembolic Disease

Registro Mexicano Multidisciplinario De Pacientes Con Enfermedad Tromboembolica Venosa0 个研究点目标入组 500 人开始时间: 2023年12月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
500
主要终点
Major adverse cardiovascular events

研究概览

简要总结

REMMITE, a retrospective and prospective registry with one-year follow-up, will provide valuable insights into the clinical diagnosis, management, treatment trends as well as related outcomes of three cohorts: DVT, DVT-PE, PE patients throughout many regions of Mexico and through different health care systems.

详细描述

Introduction Venous thromboembolism disease, (VTE) comprises deep venous thrombosis (DVT) and pulmonary embolism (PE). In United States, incidence has remained relatively constant. In Mexico, annual incidence is unknown. In spite of technological and risk stratification advances, it is still the third cause of cardiovascular and pulmonary disease. Presentation of PE is quite heterogeneous. As a complex disease with highly variable presentations in different clinical settings, DVT-PE can be confronted and managed by cardiologists, pneumologists, intensive care, internal medicine, emergency, orthopedics and surgery physicians. Thus, initial clinical approach and results can vary depending on attending physicians, experience and hospital infrastructure.

The mainstay of VTE treatment is anticoagulation, either systemic or oral. PE management, however, varies widely, depending on patient presentation but substantially on hemodynamic consequences based of right ventricle (RV) dysfunction. A careful clinical history and physical examination, integrated to electrocardiographic, laboratory and appropriate imaging findings could help to risk stratification in order to proceed to a treatment. Though some patients present with clear hemodynamic compromise, others may have an incidentally diagnosis while a test is performed for a different reason. Scoring systems can identify patients at different levels of risk. Registries may help to get key findings to quantify clinical characteristics, electrocardiographic, laboratory and modality imaging as well as treatment trends and clinical outcomes in the real world.

Results of the REMMITE, a retrospective and prospective registry with one-year follow-up, will provide valuable insights into the clinical diagnosis, management, treatment trends as well as related outcomes. The REMMITE has the potential to dictate guidelines and recommendations based on identified deficits and good practices among participating centers.

REMMITE design Primary objective: to identify clinical characteristics, treatment trends, in-hospital and 12 months follow-up outcome through major adverse cardiovascular events (MACE) of patients diagnosed either with DVT, DVT-PE, or PE.

Variables to be included In all patients: a) demographic data, b) date of onset of symptoms, c) past medical history, d) physical examination e) electrocardiographic, f) laboratory and g) imaging findings, h) treatment in acute phase, i) in-hospital and follow - up outcome, j) treatment during follow-up, k) MACE.

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 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients older than 18 years;
  • clinical diagnosis of DVT, DVT-PE, PE.

排除标准

  • chronic DVT;
  • chronic PE;
  • refusal to participate.

结局指标

主要结局

Major adverse cardiovascular events

时间窗: 12 months

to identify clinical characteristics, treatment trends, in-hospital and 12 months follow-up outcome through major adverse cardiovascular events (MACE) of patients diagnosed either with DVT, DVT-PE, or PE.

次要结局

未报告次要终点

研究者

发起方
Registro Mexicano Multidisciplinario De Pacientes Con Enfermedad Tromboembolica Venosa
申办方类型
Other
责任方
Sponsor

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