NCT04490538

Brief Summary

The purpose of this study is to validate a new echocardiographic parameter evaluating right ventricular function.

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 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

July 19, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

July 27, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 29, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
Last Updated

August 19, 2020

Status Verified

August 1, 2020

Enrollment Period

2 months

First QC Date

July 19, 2020

Last Update Submit

August 18, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Validity of sTAPSE in prediction of right ventricular systolic dysfunction

    sTAPSE is a new potential echocardiographic parameter of right ventricular systolic function measurable from subcostal view.

    During the intervention

Secondary Outcomes (1)

  • Correlation of sTAPSE with conventional TAPSE

    During the intervention

Study Arms (1)

Critically ill patients

Critically ill patients hospitalised at the intensive care unit indicated to echocardiographic examination.

Diagnostic Test: Transthoracic echocardiography

Interventions

Conventional transthoracic echocardiographic examination at the intensive care unit.

Critically ill patients

Eligibility Criteria

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

Adult intensive care unit patients.

You may qualify if:

  • Inpatients
  • All patients hospitalised in intensive care unit indicated for transthoracic echocardiography examination

You may not qualify if:

  • Age \<18 years
  • Insufficient imaging quality of transthoracic echocardiography
  • Refusal of echocardiographic examination by patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Masaryk Hospital Usti nad Labem

Ústí nad Labem, 40113, Czechia

RECRUITING

Related Publications (1)

  • 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. Eur Heart J Cardiovasc Imaging. 2015 Mar;16(3):233-70. doi: 10.1093/ehjci/jev014.

    PMID: 25712077BACKGROUND

MeSH Terms

Interventions

Echocardiography

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Roman Skulec, MD, PhD

    Masaryk Hospital Usti nad Labem

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Roman Skulec, MD, PhD

CONTACT

Tomas Parizek, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 19, 2020

First Posted

July 29, 2020

Study Start

July 27, 2020

Primary Completion

September 30, 2020

Study Completion

October 31, 2020

Last Updated

August 19, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations