Acute Cardiovascular Events Triggered by COVID-19-Related Stress

• Conditions: Ventricular Tachycardia; Sudden Cardiac Death; Acute Myocardial Infarction; Stroke, Acute

• Registration Number: NCT04368637
• Lead Sponsor: Jordan Collaborating Cardiology Group

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-04-26
• Study First Submitted QC: 2020-04-29
• Study First Posted: 2020-04-30
• Status Verified: 2020-05
• Study Start: 2020-05-03
• Last Update Submitted: 2020-05-04
• Last Update Posted: 2020-05-05
• Primary Completion: 2020-07-30
• Study Completion: 2020-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

* COVID-19 infection.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acute cardiovascular event triggered by COVID-19 stress	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	4 months	Typical ventricular tachycardia on 12-lead EKG or EKG monitor.
acute stroke	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	4 months	Finding an episode of ventricular tachycardia on interrogation of ICD tracing

Trial Locations

Locations (5)

Istishari Hospital; 🇯🇴 Amman, Jordan

Jordan Hospital; 🇯🇴 Amman, Jordan

Specialty Hospital; 🇯🇴 Amman, Jordan

Farah Hospital; 🇯🇴 Amman, Jordan

Abdelhadi Hospital; 🇯🇴 Amman, Jordan