Multimodal IMAgery Characterization of Cardiac Damage and Severity After COVID-19 Infection

NCT ID: NCT04753762

Last Updated: 2023-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-01

Study Completion Date

2022-02-01

Brief Summary

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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.

Detailed Description

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Conditions

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COVID-19 Virus Disease Cardiac Complication

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Laura FILIPPETTI

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Laura FILIPPETTI, MD

Role: PRINCIPAL_INVESTIGATOR

CHRU NANCY

Locations

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Laura FILIPPETTI

Vandœuvre-lès-Nancy, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 32031570 (View on PubMed)

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.

Reference Type RESULT
PMID: 32512122 (View on PubMed)

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.

Reference Type RESULT
PMID: 32201335 (View on PubMed)

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.

Reference Type RESULT
PMID: 32219357 (View on PubMed)

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.

Reference Type RESULT
PMID: 32360126 (View on PubMed)

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.

Reference Type RESULT
PMID: 32085846 (View on PubMed)

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.

Reference Type RESULT
PMID: 32275742 (View on PubMed)

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.

Reference Type RESULT
PMID: 28158518 (View on PubMed)

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.

Reference Type RESULT
PMID: 32499236 (View on PubMed)

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.

Reference Type RESULT
PMID: 32091533 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35355964 (View on PubMed)

Other Identifiers

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2020PI086

Identifier Type: -

Identifier Source: org_study_id

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