Influenza, HumanNCT03339180
Cardiac Injury in Patients With Influenza
An observational study of Influenza, Human and Myocardial Injury, run by Örebro University, Sweden at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Influenza, Human, Myocardial Injury
- How many people
- 466 participants
- Where
- 1 siteSweden
- Study dates
- 1 Oct 2017to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adult patients (>18 years) presenting with influenza-like illness.
- Written informed consent.
Who cannot join
- Inability to provide informed consent.
- Age <18 years.
- Symptoms indicating an acute coronary syndrome, acute heart failure, rapid atrial fibrillation or acute stroke.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Influenza, Human, Myocardial Injury
- Keywords
- cardiac troponin
- Medical subject headings
- Influenza, Human
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year
Level of biochemical markers
Level of other biochemical markers in patients with influenza
Measured: One year
Secondary outcomes (5)
Prognostic implication
Time to all-cause death
Measured: One year
Prognostic implication
Time to admission for myocardial infarction
Measured: One year
Prognostic implication
Time to admission for unstable angina
Measured: One year
Prognostic implication
Time to admission for heart failure
Measured: One year
Prognostic implication
Time to admission for stroke
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start1 Oct 2017
- Primary completion30 Apr 2022
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza, HumanStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 466 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Nordenskjöld, Örebro University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03339180
- Sponsor's protocol ID
- Do not have any
- Status last verified
- Sep 2022
- First submitted
- 26 Oct 2017
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Prognostic Implications of Cardiac Injury in Patients With Influenza-like Illness
- ClinicalTrials.gov ID
- NCT03339180
- Acronym / sponsor ID
- Do not have any
- Conditions
- Influenza, Human, Myocardial Injury
- Keywords
- cardiac troponin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 466 participants (estimated)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 13 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Adult patients (>18 years) presenting with influenza-like illness.
- Written informed consent.
Key exclusion criteria (3 listed)
- Inability to provide informed consent.
- Age <18 years.
- Symptoms indicating an acute coronary syndrome, acute heart failure, rapid atrial fibrillation or acute stroke.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Level of biochemical markers
Time frame: One year
Level of other biochemical markers in patients with influenza
5 secondary outcomes
Prognostic implication
Time frame: One year
Prognostic implication
Time frame: One year
Prognostic implication
Time frame: One year
Prognostic implication
Time frame: One year
Prognostic implication
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza, Human and Myocardial Injury, run by Örebro University, Sweden at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of biochemical markers (time frame: One year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.