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临床试验/NCT04368637
NCT04368637Unknown不适用

Acute Cardiovascular Events Triggered by COVID-19-Related, Non-infectious Stress The Jordan COVID-9 caRdiovascular Events (JoCORE) Study

Jordan Collaborating Cardiology Group5 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年5月3日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
5
主要终点
Acute cardiovascular event triggered by COVID-19 stress

研究概览

简要总结

The current COVID19 pandemic has afflicted almost the whole globe. The stress related to the pandemic, not the direct virus-related injury, can be potentially associated with acute cardiovascular events due to a large list of physical and psychosocial stresses.

This study is a cross sectional study that will enroll patients evaluated during the COVID19 pandemic period for acute cardiovascular events.

详细描述

The onset of acute myocardial infarction (AMI) is a complex interplay of internal circadian factors and external physical and emotional triggers. These interactions may lead to rupture of an often non-occlusive vulnerable atherosclerotic coronary plaque with subsequent formation of an occlusive thrombus. Physical and emotional stresses are important triggers of acute cardiovascular events including AMI. Triggering events, internal changes, and external factors vary among different geographical, environmental, and ethnic regions. Life-style changes, pharmacotherapy, and psychological interventions may potentially modify the response to, and protect against the effects of triggering events. Certain times in the life span of different communities all around the world are prone to natural and man-made disasters that, not only have direct negative impact on human lives and state-resources, but also have indirect impact on triggering acute cardiovascular events during the time of the disaster and the period immediately after. For example, earthquakes, wars, and terrorist attacks, in addition to direct human life loss and destruction of communities, have bees associated with a surge in the number of acute MI, sudden cardiac death, ventricular tachy-arrhythmia and implantable cardiovertor defibrillators (ICD) discharges.

The current COVID-19 pandemic has afflicted almost the whole globe. The virus can directly attack the myocyte and cause various degrees of cardiac damage and cardiovascular clinical entities. However, the stress related to the pandemic, not the direct virus-related injury, can be potentially associated with acute cardiovascular events due to a large list of physical and psycho-social stresses such as extreme physical effort, lock down, anger, fear, financial stress, sorrow, death of a significant person..etc.

This study is a cross sectional study that will enroll patients evaluated during the COVID-19 pandemic period for acute cardiovascular events not directory related to the virus infectivity, who voice certain and specific trigger(s) related to the pandemic impact on social life and physical activity.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

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

  • Age >18 years.
  • Acute MI (STEMI and NSTEMI).
  • Sudden cardiac death
  • Ventricular tachycardia
  • ICD shocks.
  • Stressful trigger prior to the cardiovascular event

排除标准

  • * COVID-19 infection.

结局指标

主要结局

Acute cardiovascular event triggered by COVID-19 stress

时间窗: 4 months

Acute myocardial infarction as diagnosed by ST segment elevation or depression or inverted T wave on 12-lead EKG and elevated levels of cardiac troponins above the 99% of the normal values. A. Acute MI (STEMI and NSTEMI). B. Aborted on non-aborted sudden cardiac death not attributed to a known etiology. C. Sustained or non-sustained ventricular tachy-arrhythmia not attributed to a known etiology. D. ICD shocks. 3. Absence of suspected or confirmed infection with the COVID19 virus. 4. Definite physical or psycho-social stressful trigger appearing in relation to the COVID-19 situation (lock down stress, financial stress, anger, depression, fear, sorrow, death of a significant person, eating binges, smoking binges, physical stress \[carrying walking for shopping and carrying excess weights\] ..etc) as judged by a unanimous agreement of three investigators in the steering committee.

Ventricular tachycardia

时间窗: 4 months

Typical ventricular tachycardia on 12-lead EKG or EKG monitor.

acute stroke

时间窗: 4 months

acute neurological symptoms of hemiparesis or dysrthria due to brain ischemia proven by computerized tomography or magnatic resonance

Implantable cardioverter defibrillator (ICD) shock

时间窗: 4 months

Finding an episode of ventricular tachycardia on interrogation of ICD tracing

次要结局

未报告次要终点

研究者

发起方
Jordan Collaborating Cardiology Group
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayman J. Hammoudeh, MD, FACC

Interventional Cardiologist

Jordan Collaborating Cardiology Group

研究点 (5)

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