Clinical trial NCT04368637: Acute Cardiovascular Events Triggered by COVID-19-Related Stress
Official title: Acute Cardiovascular Events Triggered by COVID-19-Related, Non-infectious Stress The Jordan COVID-9 caRdiovascular Events (JoCORE) Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Myocardial Infarction
Ventricular Tachycardia
Sudden Cardiac Death
Stroke, Acute
Keywords: COVID-19
triggered myocardial infarction
triggered acute cardiovascular events
COVID-19-related stress
Lead sponsor: Jordan Collaborating Cardiology Group
Sponsor class: OTHER
First posted: 2020-04-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All comers to the ER reporting acute cardiovascular event as pre-specified above. The patient reporting a physical or social stress directly related to the COVID-19 pandemic such as anger, fear, death of a significant person, financial stress, eating binge, extreme physical effort, etc..

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Acute cardiovascular event triggered by COVID-19 stress
timeFrame: 4 months
measure: Ventricular tachycardia
timeFrame: 4 months
measure: acute stroke
timeFrame: 4 months
measure: Implantable cardioverter defibrillator (ICD) shock
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Istishari Hospital
city: Amman
country: Jordan
facility: Abdelhadi Hospital
city: Amman
country: Jordan
facility: Farah Hospital
city: Amman
country: Jordan
facility: Jordan Hospital
city: Amman
country: Jordan
facility: Specialty Hospital
Study officials:
affiliation: JCC Group
name: Ayman J Hammoudeh, MD, FACC
role: STUDY_CHAIR
References: