Acute Cardiovascular Events Triggered by COVID-19-Related Stress (JoCORE)

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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• Jordan
  • Amman, Jordan
    • Recruiting
    • Jordan Hospital
    • Contact: Imad Alhaddad, MD; Phone Number: 00962795303502; Email: alhaddad63@gmail.com
    • Sub-Investigator: Mahmoud Fakhri, MD
  • Amman, Jordan, 11184
    • Recruiting
    • Istishari Hospital
    • Contact: Walaa Abu Moghli, PharmD; Phone Number: 0096265001000; Email: a.hammoudeh@istisharihospital.com
  • Amman, Jordan
    • Recruiting
    • Specialty Hospital
    • Contact: Mahmoud Izraiq Mahmoud Izraiq, MD
  • Amman, Jordan
    • Recruiting
    • Abdelhadi Hospital
    • Contact: Zeina Abu Orabi, MD
    • Sub-Investigator: Zeina Abu Orabi, MD
  • Amman, Jordan
    • Recruiting
    • Farah Hospital
    • Contact: Hadi Abu hantash, MD, FACC
    • Principal Investigator: Hadi Abu Hantash, MD, FACC
    • Sub-Investigator: Eyadeh Madanat, MD
    • Sub-Investigator: Zaid Khouri, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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..

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute cardiovascular event triggered by COVID-19 stress	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.	4 months
Ventricular tachycardia	Typical ventricular tachycardia on 12-lead EKG or EKG monitor.	4 months
acute stroke	acute neurological symptoms of hemiparesis or dysrthria due to brain ischemia proven by computerized tomography or magnatic resonance	4 months
Implantable cardioverter defibrillator (ICD) shock	Finding an episode of ventricular tachycardia on interrogation of ICD tracing	4 months

Collaborators and Investigators

• Sponsor: Jordan Collaborating Cardiology Group
• Investigators: Study Chair: Ayman J Hammoudeh, MD, FACC, JCC Group

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 3, 2020
• Primary Completion (ANTICIPATED): July 30, 2020
• Study Completion (ANTICIPATED): August 30, 2020

Study Registration Dates

• First Submitted: April 26, 2020
• First Submitted That Met QC Criteria: April 29, 2020
• First Posted (ACTUAL): April 30, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 5, 2020
• Last Update Submitted That Met QC Criteria: May 4, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: COVID-19; triggered myocardial infarction; triggered acute cardiovascular events; COVID-19-related stress
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Death, Sudden; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Heart Arrest; Myocardial Infarction; Infarction; Stroke; COVID-19; Death; Tachycardia; Tachycardia, Ventricular; Death, Sudden, Cardiac
• Other Study ID Numbers: JCCG.JoCORE.4.4040

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Baseline clinical data of participating patients will be shared along with the type of the triggered cardiovascular events and the type of trigger implicated in precipitating the event.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No