Cardiac Injury in Patients With Influenza

September 20, 2022 updated by: Anna Nordenskjöld, Örebro University, Sweden

Prevalence and Prognostic Implications of Cardiac Injury in Patients With Influenza-like Illness

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.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

The relationship between influenza and cardiovascular events was described in an early study of influenza epidemics from 1915 to 1929 including the 1918-1920 pandemic. Retrospective studies have shown increased risk for acute myocardial infarction (AMI) during the first week following an infection with influenza.

Biochemical markers of cardiac injury such as high sensitive cardiac troponins may be increased during infection with influenza. Increased levels of cardiac troponins are associated with adverse outcome in many different populations.

Study Type

Observational

Enrollment (Anticipated)

466

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Örebro, Sweden, 701 85
        • Örebro University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of biochemical markers
Time Frame: One year
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
Time Frame: One year
Level of other biochemical markers in patients with influenza
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prognostic implication
Time Frame: One year
Time to all-cause death
One year
Prognostic implication
Time Frame: One year
Time to admission for myocardial infarction
One year
Prognostic implication
Time Frame: One year
Time to admission for unstable angina
One year
Prognostic implication
Time Frame: One year
Time to admission for heart failure
One year
Prognostic implication
Time Frame: One year
Time to admission for stroke
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Örebro University, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2017

Primary Completion (ACTUAL)

April 30, 2022

Study Completion (ANTICIPATED)

December 31, 2023

Study Registration Dates

First Submitted

October 26, 2017

First Submitted That Met QC Criteria

November 7, 2017

First Posted (ACTUAL)

November 13, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 21, 2022

Last Update Submitted That Met QC Criteria

September 20, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Do not have any

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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