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Cardiac Injury in Patients With Influenza

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03339180
Recruitment Status : Recruiting
First Posted : November 13, 2017
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Anna Nordenskjöld, Örebro University, Sweden

Study Description
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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.

Condition or disease
Influenza, Human Myocardial Injury

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 Design
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Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence and Prognostic Implications of Cardiac Injury in Patients With Influenza-like Illness
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. Level of biochemical markers [ Time Frame: One year ]
    Level of other biochemical markers in patients with influenza


Secondary Outcome Measures :
  1. Prognostic implication [ Time Frame: One year ]
    Time to all-cause death

  2. Prognostic implication [ Time Frame: One year ]
    Time to admission for myocardial infarction

  3. Prognostic implication [ Time Frame: One year ]
    Time to admission for unstable angina

  4. Prognostic implication [ Time Frame: One year ]
    Time to admission for heart failure

  5. Prognostic implication [ Time Frame: One year ]
    Time to admission for stroke


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03339180


Locations
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Sweden
Örebro University Recruiting
Örebro, Sweden, 701 85
Contact: Anna M Nordenskjöld, M.D. Ph.D.    +46196021000    anna.nordenskjold@regionorebrolan.se   
Sponsors and Collaborators
Örebro University, Sweden
More Information
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Responsible Party: Anna Nordenskjöld, Principal Investigator, Örebro University, Sweden
ClinicalTrials.gov Identifier: NCT03339180    
Other Study ID Numbers: Do not have any
First Posted: November 13, 2017    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anna Nordenskjöld, Örebro University, Sweden:
cardiac troponin
Additional relevant MeSH terms:
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Influenza, Human
Wounds and Injuries
Respiratory Tract Infections
Infections
 Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases