Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04368637
Recruitment Status : Recruiting
First Posted : April 30, 2020
Last Update Posted : May 5, 2020
Sponsor:
Information provided by (Responsible Party):
Ayman J. Hammoudeh, MD, FACC, 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.


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.

Layout table for study information
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

Resource links provided by the National Library of Medicine





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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04368637


Contacts
Layout table for location contacts
Contact: Ayman J Hammoudeh, MD, FACC 0096265001000 hammoudeh_ayman@yahoo.com
Contact: Ayadeh Madanat, MD 00962796224241 ayadeh.madanat@gmail.com

Locations
Layout table for location information
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
Layout table for investigator information
Study Chair: Ayman J Hammoudeh, MD, FACC JCC Group
Layout table for additonal 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    Key Record Dates
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.

Layout table for additional information
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:
Layout table for 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