NCT04524234

Brief Summary

Cardiac dysfunction has been reported to be common in patients infected with COVID-19. The aim of this study is to evaluate the clinical importance of cardiac dysfunction in critically ill patients infected with COVID-19.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
132

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

5 active sites

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 20, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 24, 2020

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

December 24, 2020

Status Verified

December 1, 2020

Enrollment Period

4 months

First QC Date

August 21, 2020

Last Update Submit

December 22, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mortality

    All cause death in patients with vs without cardiac dysfunction

    30 days

Secondary Outcomes (8)

  • Left ventricular dysfunction

    Within 72 hours from admission

  • Right ventricular dysfunction

    Within 72 hours from admission

  • Risk-factors

    Within 72 hours from admission

  • Cardiac biomarkers

    Within 72 hours from admission

  • Left ventricular dysfunction

    During ICU-stay

  • +3 more secondary outcomes

Interventions

EchocardiographyDIAGNOSTIC_TEST

Echocardiography for assessment of cardiac function

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients admitted to participating unit, being infected with COVID-19 are eligible for inclusion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Södersjukhuset

Stockholm, Region Stockholm, Sweden

Location

Sahlgrenska University Hospital/Mölndal

Gothenburg, Västra Götaland County, 40530, Sweden

Location

Sahlgrenska University Hospital/Östra

Gothenburg, Västra Götaland County, 40530, Sweden

Location

Sahlgrenska University Hospital

Gothenburg, Västra Götaland County, 41345, Sweden

Location

North Älvsborg County Hospital

Trollhättan, Västra Götalandsregionen, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

COVID-19Ventricular Dysfunction, LeftVentricular Dysfunction, RightHypertension, Pulmonary

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesVentricular DysfunctionHeart DiseasesCardiovascular DiseasesHypertensionVascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Officials

  • Jonatan Oras, MD, PhD

    Sahlgrenska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

August 21, 2020

First Posted

August 24, 2020

Study Start

April 20, 2020

Primary Completion

August 31, 2020

Study Completion

September 30, 2020

Last Updated

December 24, 2020

Record last verified: 2020-12

Locations