CMR Findings in COVID-19 Patients Presenting With Myocardial Infarction

July 18, 2022 updated by: Mohamed Ahmed Abdallah Hamada, Assiut University
To compare myocardial injury in COVID 19 patients presented with myocardial infarction and non COVID Patients presented with myocardial infarction evaluated with CMR

Study Overview

Status

Active, not recruiting

Detailed Description

Coronavirus disease 2019 (COVID-19) is a global pandemic affecting 185 countries and >3 000 000 patients worldwide as of April 28, 2020. COVID-19 is caused by severe acute respiratory syndrome coronavirus 2,. Among patients with COVID-19, there is a high prevalence of cardiovascular disease, and >7% of patients experience myocardial injury from the infection (22% of critically ill patients). Although angiotensin-converting enzyme 2 serves as the portal for infection, the role of angiotensin-converting enzyme inhibitors or angiotensin receptor blockers requires further investigation.

However, much like any other respiratory tract infection, pre-existing cardiovascular disease (CVD) and CV risk factors enhance vulnerability to COVID-19. Further, COVID-19 can worsen underly- ing CVD and even precipitate de novo cardiac complications.

Preliminary reports suggest that haemostatic abnormalities, including disseminated intravascular coagulation (DIC), occur in patients affected by COVID-19. Additionally, the severe inflammatory response, critical illness, and underlying traditional risk factors may all predispose to thrombotic events, similar to prior virulent zoonotic coronavirus outbreaks CMR is the reference non-invasive standard for cardiac function and tissue characterization and may offer an effective and efficient diagnostic imaging choice to obtain critical information for clinical decision-making.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Assiut, Egypt
        • AssuitU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Included patients will be randomly divided in a 1:1 pattern into two groups. The 1st group are COVID 19 patients and the 2nd group are non COVID 19 patients as a control.

All patients will be subjected to:

A. Full history taking: including age, sex, history of DM, HTN, Smoking, dyslipidemia, symptoms of COVID 19 infection, chest pain analysis.

B. Thorough physical examination:

  • General examination including Systolic and diastolic blood pressure, heart rate assessment and O2 Saturation
  • Cardiac examination C. Twelve lead ECG: to search for STEMI criteria according to ECS guidelines of STEMI 2017.5 D. lab investigation: Cardiac enzymes, Renal function, Liver function, CBC, CRP, Lipid profile, RBG, Serum ferritin, ESR, D-Dimer, PCR.

E.MSCT chest: to detect finding suggestive of COVID 19 infection.

F.CMR:

Description

Inclusion Criteria:

  1. Patients presenting with symptoms and ECG indicative of acute MI (both STEMI & NSTEMI) AND confirmed COVID-19.
  2. Patients admitted with acute MI (both STEMI & NSTEMI) who develop COVID-19 symptoms during hospital admission & are confirmed by RT-PCR to have COVID-19

Exclusion Criteria:

  1. History of previous diagnosis of STEMI or myocarditis.
  2. History of previous PCI in infarcted related artery or NSTEMI
  3. Severe respiratory distress that precludes lying supine in the CMR scanner.
  4. Acute kidney injury with rapidly declining GFR or GFR that is persistently below 30 ml/min/1.73 m2 (contraindication for Gadopentetate dimeglumine contrast).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
COVID-19 patients presented with myocardial infarction

o CMR protocol:

  • Cine imaging to assess regional & global ventricular function according to the AHA 16-segment model.
  • T2-weighted imaging to detect extent & distribution of myocardial edema.
  • Early Gd enhancement imaging to detect extent & distribution of myocardial hyperemia.
  • Late Gd enhancement imaging to detect extent & distribution of myocardial necrosis.
  • Single-short sequences & other acceleration techniques will be used as appropriate in patients with poor ability to hold their breath.
  • Post-processing analysis will be done on a dedicated workstation
Non-COVID-19 patients presented with myocardial infarction

o CMR protocol:

  • Cine imaging to assess regional & global ventricular function according to the AHA 16-segment model.
  • T2-weighted imaging to detect extent & distribution of myocardial edema.
  • Early Gd enhancement imaging to detect extent & distribution of myocardial hyperemia.
  • Late Gd enhancement imaging to detect extent & distribution of myocardial necrosis.
  • Single-short sequences & other acceleration techniques will be used as appropriate in patients with poor ability to hold their breath.
  • Post-processing analysis will be done on a dedicated workstation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comparison between COVID-19 and COVID-19 presented with myocardial infarction
Time Frame: baseline
Distribution and Extent of myocardial injury in COVID 19 patients presented with myocardial infarction and non COVID Patients presented with myocardial infarction evaluated with CMR.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

November 12, 2020

First Submitted That Met QC Criteria

November 12, 2020

First Posted (Actual)

November 13, 2020

Study Record Updates

Last Update Posted (Actual)

July 20, 2022

Last Update Submitted That Met QC Criteria

July 18, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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