NCT03934775

Brief Summary

The goal of this study is to evaluate the prognostic values of non-invasive hemodynamic parameteres in relation to 30-day mortality and/or acute deterioration in patients who are admitted acutely to the department of emergency medicine or cardiology.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
942

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Longer than P75 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

First Submitted

Initial submission to the registry

April 29, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 2, 2019

Completed
11 days until next milestone

Study Start

First participant enrolled

May 13, 2019

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2023

Completed
Last Updated

July 20, 2023

Status Verified

July 1, 2023

Enrollment Period

3.7 years

First QC Date

April 29, 2019

Last Update Submit

July 19, 2023

Conditions

Keywords

emergency departmentrisk predictionnon-invasive hemodynamicHeart rate variability

Outcome Measures

Primary Outcomes (1)

  • 30-day mortality and/or acute deterioration.

    Death within 30 days and/or cute deterioration in term of unplanned hospital admissions or unplanned transfer to the intensive therapy or any higher level of care.

    30 days from inclusion

Secondary Outcomes (3)

  • 90-day primary outcome

    90 days from inclusion

  • Major Cardiovascular Events (MACE)

    30 days from inclusion

  • MACE 90-days

    90 days from inclusion

Study Arms (1)

Patients with acute illness

Patients admitted to the acute medical/emergency department and/or Cardiology department at Bispebjerg Hospital.

Device: Finapres Nova

Interventions

Non-invasive mesurement of hemodynamic parameters and heart rate variability

Patients with acute illness

Eligibility Criteria

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

Population is patients admitted to the department of emergency medicin and/or cardiology department at Bispebjerg Hospital, Copenhagen, Denmark.

You may qualify if:

  • Age \> 18 years
  • Admittance with acute illness at the department of medicine/emergency medicine / Cardiology at Bispebjerg Hospital
  • Able to give informed consent

You may not qualify if:

  • Terminal disease like advanced cancer or advanced organ failure with a life expectancy of less then three months.
  • Candidate for immediate intensive care therapy
  • Refuse or unable to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Hospital

Copenhagen, Capital Region, 2400, Denmark

Location

Related Publications (1)

  • Malm EHJ, Warrad W, Hadad R, Asmar A, Dominguez H, Haugaard SB, Sajadieh A. Is hyperdynamic circulation a hallmark of obesity? Int J Obes (Lond). 2025 Dec 12. doi: 10.1038/s41366-025-01981-5. Online ahead of print.

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ahmad Sajadieh, MD, DMSc

    Bispebjerg 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

April 29, 2019

First Posted

May 2, 2019

Study Start

May 13, 2019

Primary Completion

January 30, 2023

Study Completion

May 26, 2023

Last Updated

July 20, 2023

Record last verified: 2023-07

Locations