NCT04368637

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 30, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

May 3, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2020

Completed
Last Updated

May 5, 2020

Status Verified

May 1, 2020

Enrollment Period

3 months

First QC Date

April 26, 2020

Last Update Submit

May 4, 2020

Conditions

Keywords

COVID-19triggered myocardial infarctiontriggered acute cardiovascular eventsCOVID-19-related stress

Outcome Measures

Primary Outcomes (4)

  • 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

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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..

You may qualify if:

  • Age \>18 years.
  • Acute MI (STEMI and NSTEMI).
  • Sudden cardiac death
  • Ventricular tachycardia
  • ICD shocks.
  • Stressful trigger prior to the cardiovascular event

You may not qualify if:

  • \* COVID-19 infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Istishari Hospital

Amman, 11184, Jordan

RECRUITING

Abdelhadi Hospital

Amman, Jordan

RECRUITING

Farah Hospital

Amman, Jordan

RECRUITING

Jordan Hospital

Amman, Jordan

RECRUITING

Specialty Hospital

Amman, Jordan

RECRUITING

MeSH Terms

Conditions

Tachycardia, VentricularDeath, Sudden, CardiacStrokeCOVID-19

Condition Hierarchy (Ancestors)

TachycardiaArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and SymptomsHeart ArrestDeath, SuddenDeathCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Ayman J Hammoudeh, MD, FACC

    JCC Group

    STUDY CHAIR

Central Study Contacts

Ayman J Hammoudeh, MD, FACC

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Interventional Cardiologist

Study Record Dates

First Submitted

April 26, 2020

First Posted

April 30, 2020

Study Start

May 3, 2020

Primary Completion

July 30, 2020

Study Completion

August 30, 2020

Last Updated

May 5, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

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.

Locations