Acute Myocardial InfarctionJoCORENCT04368637
Acute Cardiovascular Events Triggered by COVID-19-Related Stress
An observational study of Acute Myocardial Infarction and Ventricular Tachycardia, run by Jordan Collaborating Cardiology Group at 5 sites in Jordan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Myocardial Infarction, Ventricular Tachycardia, Sudden Cardiac Death
- How many people
- 50 participants
- Where
- 5 sitesJordan
- Study dates
- 3 May 2020to 30 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Adult, Older adult
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..
Who may be able to join
- Age >18 years.
- Acute MI (STEMI and NSTEMI).
- Sudden cardiac death
- Ventricular tachycardia
- ICD shocks.
- Stressful trigger prior to the cardiovascular event
Who cannot join
- COVID-19 infection.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Jordan5 sites, 5 recruiting
- Recruiting
Istishari Hospital
Amman, 11184
Ayman Hammoudeh, MD, FACC, 0096265001000, a.hammoudeh@istisharihospital.com
Walaa Abu Moghli, PharmD, 0096265001000, a.hammoudeh@istisharihospital.com
- Recruiting
Abdelhadi Hospital
Amman
Zeina Abu Orabi, MD
Zeina Abu Orabi, MD
- Recruiting
Farah Hospital
Amman
Hadi Abu hantash, MD, FACC
Hadi Abu Hantash, MD, FACC
- Recruiting
Jordan Hospital
Amman
Imad Alhaddad, MD, 00962795303502, alhaddad63@gmail.com
Mahmoud Fakhri, MD
- Recruiting
Specialty Hospital
Amman
Mahmoud Izraiq Mahmoud Izraiq, MD
About this study
Official title: 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.
Read the 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.
- Keywords
- COVID-19, triggered myocardial infarction, triggered acute cardiovascular events, COVID-19-related stress
- Medical subject headings
- Tachycardia, Ventricular, Death, Sudden, Cardiac, Stroke, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- Acute MI (STEMI and NSTEMI). B. Aborted on non-aborted sudden cardiac death not attributed to a known etiology.
- Sustained or non-sustained ventricular tachy-arrhythmia not attributed to a known etiology.
- 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.
Measured: 4 months
Ventricular tachycardia
Typical ventricular tachycardia on 12-lead EKG or EKG monitor.
Measured: 4 months
acute stroke
acute neurological symptoms of hemiparesis or dysrthria due to brain ischemia proven by computerized tomography or magnatic resonance
Measured: 4 months
Implantable cardioverter defibrillator (ICD) shock
Finding an episode of ventricular tachycardia on interrogation of ICD tracing
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start3 May 2020
- Primary completion30 Jul 2020 (estimated)
- Study completion30 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jordan Collaborating Cardiology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman J. Hammoudeh, MD, FACC, Jordan Collaborating Cardiology Group
- Investigators
- Ayman J Hammoudeh, MD, FACC, Study chair, JCC Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04368637
- Sponsor's protocol ID
- JCCG.JoCORE.4.4040
- Acronym
- JoCORE
- Status last verified
- May 2020
- First submitted
- 26 Apr 2020
- Last updated
- 5 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Cardiovascular Events Triggered by COVID-19-Related, Non-infectious Stress The Jordan COVID-9 caRdiovascular Events (JoCORE) Study
- ClinicalTrials.gov ID
- NCT04368637
- Acronym / sponsor ID
- JoCORE / JCCG.JoCORE.4.4040
- Keywords
- COVID-19, triggered myocardial infarction, triggered acute cardiovascular events, COVID-19-related stress
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Jordan Collaborating Cardiology GroupUniversity, hospital or other
- Study start
- 3 May 2020 (actual)
- Primary completion
- 30 Jul 2020 (estimated)
- Study completion
- 30 Aug 2020 (estimated)
- First posted
- 30 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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..
Key inclusion criteria (6 listed)
- Age >18 years.
- Acute MI (STEMI and NSTEMI).
- Sudden cardiac death
- Ventricular tachycardia
- ICD shocks.
Key exclusion criteria (1 listed)
- COVID-19 infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Ventricular tachycardia
Time frame: 4 months
Typical ventricular tachycardia on 12-lead EKG or EKG monitor.
acute stroke
Time frame: 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
Time frame: 4 months
Finding an episode of ventricular tachycardia on interrogation of ICD tracing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2020.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayman J Hammoudeh, MD, FACC study chair
JCC Group
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction and Ventricular Tachycardia, run by Jordan Collaborating Cardiology Group at 5 sites in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayman J Hammoudeh, MD, FACC (0096265001000, hammoudeh_ayman@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute cardiovascular event triggered by COVID-19 stress (time frame: 4 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2020.