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Myocardial InfarctionNCT04628104

CMR Findings in COVID-19 Patients Presenting With Myocardial Infarction

An observational study of Myocardial Infarction, run by Assiut University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To compare myocardial injury in COVID 19 patients presented with myocardial infarction and non COVID Patients presented with myocardial infarction evaluated with CMR Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Myocardial Infarction
What is being tested?
cardiac magnetic resonance
Type of treatment
Surgery or procedure
How many people
60 participants
Where
1 siteEgypt
Study dates
1 Jan 2021to Oct 2023
How long will I take part?
3 Days
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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:

Who may be able to join

  • Patients presenting with symptoms and ECG indicative of acute MI (both STEMI \& NSTEMI) AND confirmed COVID-19.
  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • AssuitU

    Asyut

Other trials in Egypt

About this study

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

Read the 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.

Being tested
cardiac magnetic resonance
Medical subject headings
Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cardiac magnetic resonanceRadiation

    • 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
Study groups in NCT04628104
Study groupRoleWhat they receive
COVID-19 patients presented with myocardial infarctionNot described
Receives: Radiation: cardiac magnetic resonance
Non-COVID-19 patients presented with myocardial infarctionNot described
Receives: Radiation: cardiac magnetic resonance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. comparison between COVID-19 and COVID-19 presented with myocardial infarction

    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.

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2020
  2. Study start1 Jan 2021
  3. Primary completionOct 2022 (estimated)
  4. Study completionOct 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
60 participants (actual)
Target duration
3 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT04628104
Sponsor's protocol ID
CMR in myocardial infarction
Status last verified
Jul 2022
First submitted
12 Nov 2020
Last updated
20 Jul 2022
Results posted
No

Publications

  • Stefanini GG, Montorfano M, Trabattoni D, Andreini D, Ferrante G, Ancona M, Metra M, Curello S, Maffeo D, Pero G, Cacucci M, Assanelli E, Bellini B, Russo F, Ielasi A, Tespili M, Danzi GB, Vandoni P, Bollati M, Barbieri L, Oreglia J, Lettieri C, Cremonesi A, Carugo S, Reimers B, Condorelli G, Chieffo A. ST-Elevation Myocardial Infarction in Patients With COVID-19: Clinical and Angiographic Outcomes. Circulation. 2020 Jun 23;141(25):2113-2116. doi: 10.1161/CIRCULATIONAHA.120.047525. Epub 2020 Apr 30. No abstract available.

    PubMed 32352306

  • Mahmud E, Dauerman HL, Welt FGP, Messenger JC, Rao SV, Grines C, Mattu A, Kirtane AJ, Jauhar R, Meraj P, Rokos IC, Rumsfeld JS, Henry TD. Management of Acute Myocardial Infarction During the COVID-19 Pandemic: A Position Statement From the Society for Cardiovascular Angiography and Interventions (SCAI), the American College of Cardiology (ACC), and the American College of Emergency Physicians (ACEP). J Am Coll Cardiol. 2020 Sep 15;76(11):1375-1384. doi: 10.1016/j.jacc.2020.04.039. Epub 2020 Apr 21.

    PubMed 32330544

  • Bikdeli B, Madhavan MV, Jimenez D, Chuich T, Dreyfus I, Driggin E, Nigoghossian C, Ageno W, Madjid M, Guo Y, Tang LV, Hu Y, Giri J, Cushman M, Quere I, Dimakakos EP, Gibson CM, Lippi G, Favaloro EJ, Fareed J, Caprini JA, Tafur AJ, Burton JR, Francese DP, Wang EY, Falanga A, McLintock C, Hunt BJ, Spyropoulos AC, Barnes GD, Eikelboom JW, Weinberg I, Schulman S, Carrier M, Piazza G, Beckman JA, Steg PG, Stone GW, Rosenkranz S, Goldhaber SZ, Parikh SA, Monreal M, Krumholz HM, Konstantinides SV, Weitz JI, Lip GYH; Global COVID-19 Thrombosis Collaborative Group, Endorsed by the ISTH, NATF, ESVM, and the IUA, Supported by the ESC Working Group on Pulmonary Circulation and Right Ventricular Function. COVID-19 and Thrombotic or Thromboembolic Disease: Implications for Prevention, Antithrombotic Therapy, and Follow-Up: JACC State-of-the-Art Review. J Am Coll Cardiol. 2020 Jun 16;75(23):2950-2973. doi: 10.1016/j.jacc.2020.04.031. Epub 2020 Apr 17.

    PubMed 32311448

  • Chen C, Chen C, Yan JT, Zhou N, Zhao JP, Wang DW. [Analysis of myocardial injury in patients with COVID-19 and association between concomitant cardiovascular diseases and severity of COVID-19]. Zhonghua Xin Xue Guan Bing Za Zhi. 2020 Jul 24;48(7):567-571. doi: 10.3760/cma.j.cn112148-20200225-00123. Chinese.

    PubMed 32141280

  • 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.

    PubMed 30153967

Questions about this trial

What is this clinical trial studying?

An observational study of Myocardial Infarction, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

comparison between COVID-19 and COVID-19 presented with myocardial infarction (time frame: baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04628104, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.

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