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

• ClinicalTrials.gov Identifier: NCT04368637
• Recruitment Status: Recruiting
• First Posted: April 30, 2020
• Last Update Posted: May 5, 2020
• Sponsor: Jordan Collaborating Cardiology Group
• Information provided by (Responsible Party): Ayman J. Hammoudeh, MD, FACC, Jordan Collaborating Cardiology Group

Study Description

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.

Condition or disease
Acute Myocardial Infarction; Ventricular Tachycardia; Sudden Cardiac Death; Stroke, Acute

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 Design

• Study Type: Observational
• Estimated Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Acute Cardiovascular Events Triggered by COVID-19-Related, Non-infectious Stress The Jordan COVID-9 caRdiovascular Events (JoCORE) Study
• Actual Study Start Date: May 3, 2020
• Estimated Primary Completion Date: July 30, 2020
• Estimated Study Completion Date: August 30, 2020

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Acute cardiovascular event triggered by COVID-19 stress [ Time Frame: 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.

2. Ventricular tachycardia [ Time Frame: 4 months ]
   Typical ventricular tachycardia on 12-lead EKG or EKG monitor.
3. acute stroke [ Time Frame: 4 months ]
   acute neurological symptoms of hemiparesis or dysrthria due to brain ischemia proven by computerized tomography or magnatic resonance
4. Implantable cardioverter defibrillator (ICD) shock [ Time Frame: 4 months ]
   Finding an episode of ventricular tachycardia on interrogation of ICD tracing

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 100 Years (Adult, Older Adult)
• Sexes 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..

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.

Contacts and Locations

Contacts

Contact: Ayman J Hammoudeh, MD, FACC; 0096265001000; hammoudeh_ayman@yahoo.com

Contact: Ayadeh Madanat, MD; 00962796224241; ayadeh.madanat@gmail.com

Locations

Jordan

Istishari Hospital; Recruiting

Amman, Jordan, 11184

Contact: Ayman Hammoudeh, MD, FACC 0096265001000 a.hammoudeh@istisharihospital.com

Contact: Walaa Abu Moghli, PharmD 0096265001000 a.hammoudeh@istisharihospital.com

Abdelhadi Hospital; Recruiting

Amman, Jordan

Contact: Zeina Abu Orabi, MD

Sub-Investigator: Zeina Abu Orabi, MD

Farah Hospital; Recruiting

Amman, Jordan

Contact: Hadi Abu hantash, MD, FACC

Principal Investigator: Hadi Abu Hantash, MD, FACC

Sub-Investigator: Eyadeh Madanat, MD

Sub-Investigator: Zaid Khouri, MD

Jordan Hospital; Recruiting

Amman, Jordan

Contact: Imad Alhaddad, MD 00962795303502 alhaddad63@gmail.com

Sub-Investigator: Mahmoud Fakhri, MD

Specialty Hospital; Recruiting

Amman, Jordan

Contact: Mahmoud Izraiq Mahmoud Izraiq, MD

Sponsors and Collaborators

Jordan Collaborating Cardiology Group

Investigators

• Study Chair: Ayman J Hammoudeh, MD, FACC; JCC Group

More Information

• Responsible Party: Ayman J. Hammoudeh, MD, FACC, Interventional Cardiologist, Jordan Collaborating Cardiology Group
• ClinicalTrials.gov Identifier: NCT04368637
• Other Study ID Numbers: JCCG.JoCORE.4.4040
• First Posted: April 30, 2020
• Last Update Posted: May 5, 2020
• Last Verified: May 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ayman J. Hammoudeh, MD, FACC, Jordan Collaborating Cardiology Group:

COVID-19; triggered myocardial infarction; triggered acute cardiovascular events; COVID-19-related stress

Additional relevant MeSH terms:

Stroke; Myocardial Infarction; Tachycardia; Tachycardia, Ventricular; Death, Sudden, Cardiac; Infarction; Death; Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Heart Arrest; Death, Sudden; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases