NCT04628195

Brief Summary

Although COVID-19 affects primarily the respiratory system, several studies have shown evidence of cardiovascular alterations. Increased troponin levels were observed in a significant proportion of patients and this alteration was associated with higher mortality. In addition, case reports of cardiogenic shock or fulminant myocarditis have been communicated. Likewise, pulmonary embolism (PE), right ventricle dilation, and acute cor pulmonale (ACP) have also been described. Therefore, investigating cardiac function in COVID-19 is highly relevant, particularly in critically ill patients who are usually under sedation and mechanical ventilation, which may further impair cardiovascular function. Thus the objective is to determine the prevalence of left ventricle dysfunction and acute cor pulmonale, and its association with respiratory mechanics, in 100 consecutive critically ill COVID-19 patients, who were assessed with critical care echocardiography (CCE) within the first 24 hours of mechanical ventilation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

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

April 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 13, 2020

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

3 months

First QC Date

November 10, 2020

Last Update Submit

November 12, 2020

Conditions

Keywords

Critical Care EchocardiographyCardiac FunctionAcute Cor PulmonaleCOVID-19Mechanical VentilationSARS-CoV-2

Outcome Measures

Primary Outcomes (2)

  • Percentage of patients with left ventricle dysfunction (hypokinetic)

    Hypokinetic left ventricle function (left ventricle ejection fraction \<45%)

    3 month

  • Percentage of patients with acute cor pulmonale

    Acute cor pulmonale was defined as a dilated right ventricle (right ventricle end-diastolic area/left ventricle end-diastolic area ratio \>0.6) associated with the presence of paradoxical septum motion

    3 month

Secondary Outcomes (3)

  • Differences in respiratory system compliance between patients with and without acute cor pulmonale

    Within the first 24 hours of mechanical ventilation.

  • Differences in partial arterial pressure of carbon dioxide (PCO2) between patients with and without acute cor pulmonale

    Within the first 24 hours of mechanical ventilation.

  • Differences in PaO2/FiO2 ratio between patients with and without acute cor pulmonale

    Within the first 24 hours of mechanical ventilation.

Eligibility Criteria

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

Patients with severe SARS-CoV-2 pneumonia, defined as respiratory failure requiring invasive mechanical ventilation.

You may qualify if:

  • Covid-19 confirmed by a positive polymerase chain reaction test
  • Mechanical ventilation

You may not qualify if:

  • Up to 24 hours on mechanical ventilation
  • Severe valvulopathy
  • Poor ultrasound window
  • Do-not-resuscitate status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pontificia Universidad Católica de Chile

Santiago, Santiago Metropolitan, 7550028, Chile

Location

Related Publications (20)

  • Shi S, Qin M, Shen B, Cai Y, Liu T, Yang F, Gong W, Liu X, Liang J, Zhao Q, Huang H, Yang B, Huang C. Association of Cardiac Injury With Mortality in Hospitalized Patients With COVID-19 in Wuhan, China. JAMA Cardiol. 2020 Jul 1;5(7):802-810. doi: 10.1001/jamacardio.2020.0950.

    PMID: 32211816BACKGROUND
  • Deng Q, Hu B, Zhang Y, Wang H, Zhou X, Hu W, Cheng Y, Yan J, Ping H, Zhou Q. Suspected myocardial injury in patients with COVID-19: Evidence from front-line clinical observation in Wuhan, China. Int J Cardiol. 2020 Jul 15;311:116-121. doi: 10.1016/j.ijcard.2020.03.087. Epub 2020 Apr 8.

    PMID: 32291207BACKGROUND
  • Rath D, Petersen-Uribe A, Avdiu A, Witzel K, Jaeger P, Zdanyte M, Heinzmann D, Tavlaki E, Muller K, Gawaz MP. Impaired cardiac function is associated with mortality in patients with acute COVID-19 infection. Clin Res Cardiol. 2020 Dec;109(12):1491-1499. doi: 10.1007/s00392-020-01683-0. Epub 2020 Jun 14.

    PMID: 32537662BACKGROUND
  • 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: 32219357BACKGROUND
  • Zeng JH, Liu YX, Yuan J, Wang FX, Wu WB, Li JX, Wang LF, Gao H, Wang Y, Dong CF, Li YJ, Xie XJ, Feng C, Liu L. First case of COVID-19 complicated with fulminant myocarditis: a case report and insights. Infection. 2020 Oct;48(5):773-777. doi: 10.1007/s15010-020-01424-5. Epub 2020 Apr 10.

    PMID: 32277408BACKGROUND
  • Szekely Y, Lichter Y, Taieb P, Banai A, Hochstadt A, Merdler I, Gal Oz A, Rothschild E, Baruch G, Peri Y, Arbel Y, Topilsky Y. Spectrum of Cardiac Manifestations in COVID-19: A Systematic Echocardiographic Study. Circulation. 2020 Jul 28;142(4):342-353. doi: 10.1161/CIRCULATIONAHA.120.047971. Epub 2020 May 29.

    PMID: 32469253BACKGROUND
  • Dweck MR, Bularga A, Hahn RT, Bing R, Lee KK, Chapman AR, White A, Salvo GD, Sade LE, Pearce K, Newby DE, Popescu BA, Donal E, Cosyns B, Edvardsen T, Mills NL, Haugaa K. Global evaluation of echocardiography in patients with COVID-19. Eur Heart J Cardiovasc Imaging. 2020 Sep 1;21(9):949-958. doi: 10.1093/ehjci/jeaa178.

    PMID: 32556199BACKGROUND
  • Mahmoud-Elsayed HM, Moody WE, Bradlow WM, Khan-Kheil AM, Senior J, Hudsmith LE, Steeds RP. Echocardiographic Findings in Patients With COVID-19 Pneumonia. Can J Cardiol. 2020 Aug;36(8):1203-1207. doi: 10.1016/j.cjca.2020.05.030. Epub 2020 May 28.

    PMID: 32474111BACKGROUND
  • Helms J, Tacquard C, Severac F, Leonard-Lorant I, Ohana M, Delabranche X, Merdji H, Clere-Jehl R, Schenck M, Fagot Gandet F, Fafi-Kremer S, Castelain V, Schneider F, Grunebaum L, Angles-Cano E, Sattler L, Mertes PM, Meziani F; CRICS TRIGGERSEP Group (Clinical Research in Intensive Care and Sepsis Trial Group for Global Evaluation and Research in Sepsis). High risk of thrombosis in patients with severe SARS-CoV-2 infection: a multicenter prospective cohort study. Intensive Care Med. 2020 Jun;46(6):1089-1098. doi: 10.1007/s00134-020-06062-x. Epub 2020 May 4.

    PMID: 32367170BACKGROUND
  • Evrard B, Goudelin M, Montmagnon N, Fedou AL, Lafon T, Vignon P. Cardiovascular phenotypes in ventilated patients with COVID-19 acute respiratory distress syndrome. Crit Care. 2020 May 18;24(1):236. doi: 10.1186/s13054-020-02958-8. No abstract available.

    PMID: 32423461BACKGROUND
  • Expert Round Table on Echocardiography in ICU. International consensus statement on training standards for advanced critical care echocardiography. Intensive Care Med. 2014 May;40(5):654-66. doi: 10.1007/s00134-014-3228-5. Epub 2014 Mar 11. No abstract available.

    PMID: 24615559BACKGROUND
  • Lang RM, Badano LP, Mor-Avi V, Afilalo J, Armstrong A, Ernande L, Flachskampf FA, Foster E, Goldstein SA, Kuznetsova T, Lancellotti P, Muraru D, Picard MH, Rietzschel ER, Rudski L, Spencer KT, Tsang W, Voigt JU. Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J Am Soc Echocardiogr. 2015 Jan;28(1):1-39.e14. doi: 10.1016/j.echo.2014.10.003.

    PMID: 25559473BACKGROUND
  • Nagueh SF, Smiseth OA, Appleton CP, Byrd BF 3rd, Dokainish H, Edvardsen T, Flachskampf FA, Gillebert TC, Klein AL, Lancellotti P, Marino P, Oh JK, Alexandru Popescu B, Waggoner AD; Houston, Texas; Oslo, Norway; Phoenix, Arizona; Nashville, Tennessee; Hamilton, Ontario, Canada; Uppsala, Sweden; Ghent and Liege, Belgium; Cleveland, Ohio; Novara, Italy; Rochester, Minnesota; Bucharest, Romania; and St. Louis, Missouri. Recommendations for the Evaluation of Left Ventricular Diastolic Function by Echocardiography: An Update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. Eur Heart J Cardiovasc Imaging. 2016 Dec;17(12):1321-1360. doi: 10.1093/ehjci/jew082. Epub 2016 Jul 15. No abstract available.

    PMID: 27422899BACKGROUND
  • McLean AS, Needham A, Stewart D, Parkin R. Estimation of cardiac output by noninvasive echocardiographic techniques in the critically ill subject. Anaesth Intensive Care. 1997 Jun;25(3):250-4. doi: 10.1177/0310057X9702500307.

    PMID: 9209605BACKGROUND
  • Alam M, Hoglund C, Thorstrand C, Hellekant C. Haemodynamic significance of the atrioventricular plane displacement in patients with coronary artery disease. Eur Heart J. 1992 Feb;13(2):194-200. doi: 10.1093/oxfordjournals.eurheartj.a060146.

    PMID: 1555616BACKGROUND
  • Gulati VK, Katz WE, Follansbee WP, Gorcsan J 3rd. Mitral annular descent velocity by tissue Doppler echocardiography as an index of global left ventricular function. Am J Cardiol. 1996 May 1;77(11):979-84. doi: 10.1016/s0002-9149(96)00033-1.

    PMID: 8644649BACKGROUND
  • Jardin F, Dubourg O, Bourdarias JP. Echocardiographic pattern of acute cor pulmonale. Chest. 1997 Jan;111(1):209-17. doi: 10.1378/chest.111.1.209. No abstract available.

    PMID: 8996019BACKGROUND
  • Mekontso Dessap A, Boissier F, Charron C, Begot E, Repesse X, Legras A, Brun-Buisson C, Vignon P, Vieillard-Baron A. Acute cor pulmonale during protective ventilation for acute respiratory distress syndrome: prevalence, predictors, and clinical impact. Intensive Care Med. 2016 May;42(5):862-870. doi: 10.1007/s00134-015-4141-2. Epub 2015 Dec 9.

    PMID: 26650055BACKGROUND
  • Lamia B, Teboul JL, Monnet X, Richard C, Chemla D. Relationship between the tricuspid annular plane systolic excursion and right and left ventricular function in critically ill patients. Intensive Care Med. 2007 Dec;33(12):2143-9. doi: 10.1007/s00134-007-0881-y. Epub 2007 Oct 10.

    PMID: 17928992BACKGROUND
  • Edul VS, Ince C, Vazquez AR, Rubatto PN, Espinoza ED, Welsh S, Enrico C, Dubin A. Similar Microcirculatory Alterations in Patients with Normodynamic and Hyperdynamic Septic Shock. Ann Am Thorac Soc. 2016 Feb;13(2):240-7. doi: 10.1513/AnnalsATS.201509-606OC.

    PMID: 26624559BACKGROUND

MeSH Terms

Conditions

COVID-19Heart Failure

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D. Intensivist

Study Record Dates

First Submitted

November 10, 2020

First Posted

November 13, 2020

Study Start

April 1, 2020

Primary Completion

June 30, 2020

Study Completion

August 1, 2020

Last Updated

November 13, 2020

Record last verified: 2020-11

Locations