NCT04753762

Brief Summary

Coronavirus Disease 2019 (COVID-19) is an infection caused by Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2), which affects multiple organ system particularly the lung and heart. Indeed, SARS CoV-2 has various cardiac manifestations which are associated with higher mortality and morbidity. Cardiac involvement, based on elevated levels of myocardial enzymes, have been described in 20 to 30% of COVID-19 infection. However, the physiopathological mechanisms of myocardial injury remains unclear. Main hypothesis include inflammation and cytokine storm, hypercoagulability and vascular thrombosis, inflammation or stress leading to coronary plaque rupture (type I myocardial infarction), supply-demand mismatch and hypoxemia resulting in myocardial damage (type II myocardial infarction) ... Two patterns can be identified : ischemic or non-ischemic pattern including myocarditis, stress induced cardiomyopathy, thrombo-embolic disease. However, the consequences of myocardial damage after confirmed COVID-19 infection are unknown at medium to long term prognosis. Data are needed to identify myocardial damage and to guide effective therapies and follow-up (use of ACE inhibitor, beta-blockers, steroids...? ) In this study, the investigators proposed to collect multimodal cardiac imaging including MRI (Magnetic Resonance Imaging) and TTE (Transthoracic echocardiogram) in order to identify and characterize cardiac injury as ischemic or non-ischemic pattern, to better assess risk stratification and to guide effective therapies if necessary.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 15, 2021

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

May 8, 2023

Status Verified

May 1, 2023

Enrollment Period

10 months

First QC Date

January 26, 2021

Last Update Submit

May 5, 2023

Conditions

COVID-19 Virus DiseaseCardiac Complication

Outcome Measures

Primary Outcomes (2)

  • To Characterize cardiac involvement by cardiac TTE imaging during 4 months after confirmed COVID-19 infection

    Cardiac TTE imaging is performed during 4 months after COVID-19 infection in patients with suspected cardiac involvement (increase troponin level\>50ng/ml or left ventricular dysfunction during hospitalisation for COVID-19 infection) in order to determine tissular characterization, in particular the presence of ischemic or non-ischemic pattern.

    1 to 4 months after COVID 19 infection

  • To Characterize cardiac involvement by cardiac MRI during 4 months after confirmed COVID-19 infection

    Cardiac MRI is performed during 4 months after COVID-19 infection in patients with suspected cardiac involvement (increase troponin level\>50ng/ml or left ventricular dysfunction during hospitalisation for COVID-19 infection) in order to determine tissular characterization, in particular the presence of ischemic or non-ischemic pattern.

    1 to 4 months after COVID 19 infection

Secondary Outcomes (3)

  • To characterize cardiac evolution at 12 +/-2 months from COVID-19 infection

    12 +/- 2 months

  • To evaluate Cardiac events at 12 +/-2 months from COVID-19 infection

    12+/-2 months

  • To evaluate all cause deaths at 12 +/-2 months from COVID-19 infection

    12+/-2 months

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients increase troponin level \> 50ng/ml or left ventricular dysfunction assessed by echocardiography during hospitalization for confirmed COVID-19 infection

You may qualify if:

  • Cardiac involvement confirmed : increase troponin level \> 50pg/ml or left ventricular dysfunction assessed by echocardiography during hospitalization for confirmed COVID-19 infection
  • Absence of severe renal failure (CKD EPI \> 30ml/min/1.73m²)
  • Cardic imaging (MRI and TTE) performed during 4 months from COVID-19 infection

You may not qualify if:

  • Cardiovascular history (ischemic or valvular disease, dilated cardiomyopathy, cardiac surgery...)
  • Vulnerable patient (pregnancy, adult under legal protection)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laura FILIPPETTI

Vandœuvre-lès-Nancy, 54500, France

Location

Related Publications (11)

  • Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.

    PMID: 32031570RESULT

  • Bavishi C, Bonow RO, Trivedi V, Abbott JD, Messerli FH, Bhatt DL. Special Article - Acute myocardial injury in patients hospitalized with COVID-19 infection: A review. Prog Cardiovasc Dis. 2020 Sep-Oct;63(5):682-689. doi: 10.1016/j.pcad.2020.05.013. Epub 2020 Jun 6.

    PMID: 32512122RESULT

  • Driggin E, Madhavan MV, Bikdeli B, Chuich T, Laracy J, Biondi-Zoccai G, Brown TS, Der Nigoghossian C, Zidar DA, Haythe J, Brodie D, Beckman JA, Kirtane AJ, Stone GW, Krumholz HM, Parikh SA. Cardiovascular Considerations for Patients, Health Care Workers, and Health Systems During the COVID-19 Pandemic. J Am Coll Cardiol. 2020 May 12;75(18):2352-2371. doi: 10.1016/j.jacc.2020.03.031. Epub 2020 Mar 19.

    PMID: 32201335RESULT

  • Inciardi RM, Lupi L, Zaccone G, Italia L, Raffo M, Tomasoni D, Cani DS, Cerini M, Farina D, Gavazzi E, Maroldi R, Adamo M, Ammirati E, Sinagra G, Lombardi CM, Metra M. Cardiac Involvement in a Patient With Coronavirus Disease 2019 (COVID-19). JAMA Cardiol. 2020 Jul 1;5(7):819-824. doi: 10.1001/jamacardio.2020.1096.

    PMID: 32219357RESULT

  • Babapoor-Farrokhran S, Gill D, Walker J, Rasekhi RT, Bozorgnia B, Amanullah A. Myocardial injury and COVID-19: Possible mechanisms. Life Sci. 2020 Jul 15;253:117723. doi: 10.1016/j.lfs.2020.117723. Epub 2020 Apr 28.

    PMID: 32360126RESULT

  • Xu Z, Shi L, Wang Y, Zhang J, Huang L, Zhang C, Liu S, Zhao P, Liu H, Zhu L, Tai Y, Bai C, Gao T, Song J, Xia P, Dong J, Zhao J, Wang FS. Pathological findings of COVID-19 associated with acute respiratory distress syndrome. Lancet Respir Med. 2020 Apr;8(4):420-422. doi: 10.1016/S2213-2600(20)30076-X. Epub 2020 Feb 18. No abstract available.

    PMID: 32085846RESULT

  • Barton LM, Duval EJ, Stroberg E, Ghosh S, Mukhopadhyay S. COVID-19 Autopsies, Oklahoma, USA. Am J Clin Pathol. 2020 May 5;153(6):725-733. doi: 10.1093/ajcp/aqaa062.

    PMID: 32275742RESULT

  • Agewall S, Beltrame JF, Reynolds HR, Niessner A, Rosano G, Caforio AL, De Caterina R, Zimarino M, Roffi M, Kjeldsen K, Atar D, Kaski JC, Sechtem U, Tornvall P; WG on Cardiovascular Pharmacotherapy. ESC working group position paper on myocardial infarction with non-obstructive coronary arteries. Eur Heart J. 2017 Jan 14;38(3):143-153. doi: 10.1093/eurheartj/ehw149. No abstract available.

    PMID: 28158518RESULT

  • Imazio M, Klingel K, Kindermann I, Brucato A, De Rosa FG, Adler Y, De Ferrari GM. COVID-19 pandemic and troponin: indirect myocardial injury, myocardial inflammation or myocarditis? Heart. 2020 Aug;106(15):1127-1131. doi: 10.1136/heartjnl-2020-317186. Epub 2020 Jun 4.

    PMID: 32499236RESULT

  • Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.

    PMID: 32091533RESULT

  • Filippetti L, Pace N, Louis JS, Mandry D, Goehringer F, Rocher MS, Jay N, Selton-Suty C, Hossu G, Huttin O, Marie PY. Long-Lasting Myocardial and Skeletal Muscle Damage Evidenced by Serial CMR During the First Year in COVID-19 Patients From the First Wave. Front Cardiovasc Med. 2022 Mar 9;9:831580. doi: 10.3389/fcvm.2022.831580. eCollection 2022.

    PMID: 35355964DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Laura FILIPPETTI, MD

    CHRU NANCY

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

January 26, 2021

First Posted

February 15, 2021

Study Start

March 1, 2020

Primary Completion

January 1, 2021

Study Completion

February 1, 2022

Last Updated

May 8, 2023

Record last verified: 2023-05

Locations

FR(1)