NCT04628104

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

November 12, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 13, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

July 20, 2022

Status Verified

July 1, 2022

Enrollment Period

1.7 years

First QC Date

November 12, 2020

Last Update Submit

July 18, 2022

Conditions

Myocardial Infarction

Outcome Measures

Primary Outcomes (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.

    baseline

Study Arms (2)

COVID-19 patients presented with myocardial infarction

Radiation: cardiac magnetic resonance

Non-COVID-19 patients presented with myocardial infarction

Radiation: cardiac magnetic resonance

Interventions

cardiac magnetic resonanceRADIATION

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

COVID-19 patients presented with myocardial infarctionNon-COVID-19 patients presented with myocardial infarction

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AssuitU

Asyut, Egypt

Location

Related Publications (5)

  • 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.

    PMID: 32352306BACKGROUND

  • 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.

    PMID: 32330544BACKGROUND

  • 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.

    PMID: 32311448BACKGROUND

  • 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.

    PMID: 32141280BACKGROUND

  • 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.

    PMID: 30153967BACKGROUND

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
3 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

November 12, 2020

First Posted

November 13, 2020

Study Start

January 1, 2021

Primary Completion

October 1, 2022

Study Completion

October 1, 2023

Last Updated

July 20, 2022

Record last verified: 2022-07

Locations

EG(1)