NCT04584411

Brief Summary

Detection of the incidence and types of arrhythmia and conduction block in COVID - 19 patients Detection and description of CMR patterns of myocardial injury in COVID-19 patients with arrhythmias.

Trial Health

35
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 Nov 2020

Typical duration for all trials

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

September 9, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 14, 2020

Completed
18 days until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

October 14, 2020

Status Verified

October 1, 2020

Enrollment Period

1 year

First QC Date

September 9, 2020

Last Update Submit

October 10, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the incidence of arrhythmia and conduction block in COVID-19 patients using Holter

    baseline

Secondary Outcomes (1)

  • Detection of myocardial injury in COVID-19 patients using CMR.

    baseline

Interventions

The following basic sequences will be conducted: * Cine imaging using SSFP sequence for cardiac structure and function. * Tissue characterization imaging, T1 and T2. * Myocardial perfusion imaging. * Late gadolinium enhancement. Diagnosis of myocarditis will be based on the modified Lake Louise criteria: T2-weighted: any of the following standard T2 sequences: regional high signal standard T2 sequences: global signal intensity ratio (myocardium/skeletal muscle) ≥2 T2 mapping: increased T2 relaxation times T1-weighted: any of the following late enhancement imaging: non-ischemic (subepicardial or mid myocardial) late enhancement native T1 mapping: increased T1 relaxation times or extracellular volume supportive criteria: signs of pericarditis: effusion or pericardial late enhancement regional or global wall motion abnormalities\[5\]

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will include 50 confirmed COVID-19 patients admitted to Assiut University Heart Centre and critical care unit, internal medicine department within the next 6 months complaining of arrhythmias and heart block. These patients will be followed-up for a period of 6 months after discharge.

You may qualify if:

  • COVID 19 suspected patients presented by chest pain, dyspnea, chest discomfort \&/or palpitations
  • ECG changes (LBBB, PVCs, ventricular tachycardia, AF, atrial flutter, ST-T changes, and conduction defects).
  • Increased inflammatory markers and / or Tropnin-I.

You may not qualify if:

  • COVID 19 patients without ECG changes.
  • Patients known to have the same pattern of arrhythmia or conduction system defects before Covid-19 infection.
  • Patients contraindicated for CMR.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Pirzada A, Mokhtar AT, Moeller AD. COVID-19 and Myocarditis: What Do We Know So Far? CJC Open. 2020 May 28;2(4):278-285. doi: 10.1016/j.cjco.2020.05.005. eCollection 2020 Jul.

    PMID: 32691024BACKGROUND
  • Bhatla A, Mayer MM, Adusumalli S, Hyman MC, Oh E, Tierney A, Moss J, Chahal AA, Anesi G, Denduluri S, Domenico CM, Arkles J, Abella BS, Bullinga JR, Callans DJ, Dixit S, Epstein AE, Frankel DS, Garcia FC, Kumareswaram R, Nazarian S, Riley MP, Santangeli P, Schaller RD, Supple GE, Lin D, Marchlinski F, Deo R. COVID-19 and cardiac arrhythmias. Heart Rhythm. 2020 Sep;17(9):1439-1444. doi: 10.1016/j.hrthm.2020.06.016. Epub 2020 Jun 22.

    PMID: 32585191BACKGROUND
  • Shirazi S, Mami S, Mohtadi N, Ghaysouri A, Tavan H, Nazari A, Kokhazadeh T, Mollazadeh R. Sudden cardiac death in COVID-19 patients, a report of three cases. Future Cardiol. 2021 Jan;17(1):113-118. doi: 10.2217/fca-2020-0082. Epub 2020 Jul 3.

    PMID: 32615807BACKGROUND
  • B. Siripanthong et al., "Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID- company ' s public news and information website . Elsevier hereby grants permission to make all its COVID-19-r," no. January, 2020.

    BACKGROUND
  • Ferreira VM, Schulz-Menger J, Holmvang G, Kramer CM, Carbone I, Sechtem U, Kindermann I, Gutberlet M, Cooper LT, Liu P, Friedrich MG. Cardiovascular Magnetic Resonance in Nonischemic Myocardial Inflammation: Expert Recommendations. J Am Coll Cardiol. 2018 Dec 18;72(24):3158-3176. doi: 10.1016/j.jacc.2018.09.072.

    PMID: 30545455BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Doaa A Fouad, Doctorate

    Assiut University

    PRINCIPAL INVESTIGATOR
  • Alaa A El-Moniem, Doctorate

    Assiut University

    PRINCIPAL INVESTIGATOR
  • Mohamed A.H Abdelhafez, Doctorate

    Assiut University

    PRINCIPAL INVESTIGATOR
  • Shimaa S Khider, Doctorate

    Assiut University

    PRINCIPAL INVESTIGATOR
  • Ahmed AR Hassaan, bachelor

    Assiut University

    PRINCIPAL INVESTIGATOR
  • Maram M Shafiq, student

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed AR Hassaan, bachelor

CONTACT

Doaa A Fouad, Doctorate

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident

Study Record Dates

First Submitted

September 9, 2020

First Posted

October 14, 2020

Study Start

November 1, 2020

Primary Completion

November 1, 2021

Study Completion

January 1, 2024

Last Updated

October 14, 2020

Record last verified: 2020-10