NCT03339180

Brief Summary

This study investigate the prevalence of elevated biomarkers of cardiac injury in patients with suspected influenza infection and the prognostic implication on the composite endpoint of death of any cause, hospitalization due to myocardial infarction, unstable angina, heart failure and stroke.

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
466

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2017

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 13, 2017

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

September 21, 2022

Status Verified

September 1, 2022

Enrollment Period

4.6 years

First QC Date

October 26, 2017

Last Update Submit

September 20, 2022

Conditions

Influenza, HumanMyocardial Injury

Keywords

cardiac troponin

Outcome Measures

Primary Outcomes (2)

  • Level of biochemical markers

    Level of cardiac troponin in patients with influenza The level of hs-cTn, NT-proBNP and hs-CRP at inclusion in patients with and patientes without influenza.

    One year

  • Level of biochemical markers

    Level of other biochemical markers in patients with influenza

    One year

Secondary Outcomes (5)

  • Prognostic implication

    One year

  • Prognostic implication

    One year

  • Prognostic implication

    One year

  • Prognostic implication

    One year

  • Prognostic implication

    One year

Eligibility Criteria

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

The clinical study will be conducted in Region Örebro County. Recruitment will start October 1st 2017 and is expected to continue for two influenza seasons until April 30, 2019. Individuals for inclusion are recruited among adult patients \> 18 years presenting with influenza-like illness at the emergency unit and who, due to strong clinical suspicion of ongoing influenza infection, are tested.

You may qualify if:

  • Adult patients (\>18 years) presenting with influenza-like illness.
  • Written informed consent.

You may not qualify if:

  • Inability to provide informed consent.
  • Age \<18 years.
  • Symptoms indicating an acute coronary syndrome, acute heart failure, rapid atrial fibrillation or acute stroke.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Örebro University

Örebro, 701 85, Sweden

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Design

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

Study Record Dates

First Submitted

October 26, 2017

First Posted

November 13, 2017

Study Start

October 1, 2017

Primary Completion

April 30, 2022

Study Completion

December 31, 2023

Last Updated

September 21, 2022

Record last verified: 2022-09

Locations

SE(1)