Clinical trial NCT04628104: CMR Findings in COVID-19 Patients Presenting With Myocardial Infarction
Official title: CMR Findings in COVID-19 Patients Presenting With Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myocardial Infarction
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-11-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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:

Brief summary: To compare myocardial injury in COVID 19 patients presented with myocardial infarction and non COVID Patients presented with myocardial infarction evaluated with CMR

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.

Eligibility criteria: 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).

Primary outcomes:
measure: comparison between COVID-19 and COVID-19 presented with myocardial infarction
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: AssuitU
Study officials:
References:
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citation: Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction. Fourth Universal Definition of Myocardial Infarction (2018). J Am Coll Cardiol. 2018 Oct 30;72(18):2231-2264. doi: 10.1016/j.jacc.2018.08.1038. Epub 2018 Aug 25. No abstract available.