Patterns of Arrhythmias and Conduction Block in COVID-19 Patients and Its Relation to Myocardial Injury Detected by Cardiac Magnetic Resonance
1 other identifier
observational
50
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2020
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2020
CompletedFirst Posted
Study publicly available on registry
October 14, 2020
CompletedStudy Start
First participant enrolled
November 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2024
CompletedOctober 14, 2020
October 1, 2020
1 year
September 9, 2020
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
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: 32691024BACKGROUNDBhatla 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: 32585191BACKGROUNDShirazi 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: 32615807BACKGROUNDB. 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.
BACKGROUNDFerreira 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
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
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
Central Study Contacts
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