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Study on the Effect of Influenza Vaccination After Heart Attack on Future Cardiovascular Prognosis (IAMI)

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ClinicalTrials.gov Identifier: NCT02831608
Recruitment Status : Recruiting
First Posted : July 13, 2016
Last Update Posted : July 8, 2019
Sponsor:
Collaborators:
Swedish Heart Lung Foundation
Sanofi Pasteur, a Sanofi Company
Uppsala University
Lytics
Information provided by (Responsible Party):
Ole Frobert, MD, PhD, Region Örebro County

Brief Summary:

Background. For more than a century a causal link between influenza and cardiovascular disease has been suspected. It is conceivable that influenza may precipitate plaque rupture, increase cytokines with central roles in plaque destabilization and trigger the coagulation cascade. Accordingly, registry studies, case control studies and a few small randomized trials, all underpowered for clinical endpoints, have demonstrated that the risk for acute myocardial infarction (AMI) is increased following respiratory infection and that the risk of stroke and AMI in patients with established cardiovascular disease seem to be reduced following influenza vaccination. In May 2015 a Cochrane review concluded that influenza vaccination may reduce cardiovascular mortality and cardiovascular events but bias and inconsistent results in prior studies require higher-quality evidence to confirm these findings. High costs and little commercial interest in conducting a randomized trial on influenza vaccine in cardiovascular disease stand in the way.

Objective. The objective is to document whether influenza vaccination protects against cardiovascular events and death after an AMI.

Methods. Population: 4400 patients with ST-elevation (STEMI) or non-ST elevation myocardial infarction (NSTEMI) are randomized 1:1 in a blinded fashion using an RRCT design and followed up via registries and two telephone calls. Intervention: Influenza vaccination. Control: Placebo (saline). Outcome: The primary endpoint is a composite of death, myocardial infarction and stent thrombosis till 1 year in patients with STEMI/NSTEMI undergoing coronary angiography/PCI. Patients will be included in the study in all of Sweden's 7 university hospitals and 2 general hospitals, 4 university hospitals and 1 general hospital in Denmark, in 1 specialized heart center in Norway, 3 university hospitals in Czech Republic, 5 hospitals in Scotland and 1 university hospital in Latvia. Secondary endpoints are time to all-cause death, time to stent thrombosis, time to revascularization, time to myocardial infarction, time to stroke or time to rehospitalization for heart failure till 1 year, 2 years, 3 years and 5 years. Furthermore, an extensive health-economic analysis will be conducted. The trial has been approved by the ethical committee system (Dnr 2014/264) and the Medical Products Agency (EudraCTnr -2014-001354-42) in Sweden.

Perspectives. If a clinical benefit can be demonstrated in this prospective trial influenza vaccination may become an important novel in-hospital therapy for patients with cardiovascular disease and the accompanying direct and indirect societal gains will be profound. IAMI will be the first placebo-controlled RRCT conducted.


Condition or disease Intervention/treatment Phase
Myocardial Infarction Influenza, Human Influenza Vaccines Heart Failure Stroke Biological: Influenza vaccine Biological: Placebo Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Influenza Vaccination After Myocardial Infarction (IAMI Trial): A Multicenter, Prospective, Randomized Controlled Clinical Trial Based on the Swedish Angiography and Angioplasty Registry (SCAAR) Platform
Study Start Date : October 2016
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Drug: influenza vaccine
Standard influenza vaccine administered as a deep subcutaneous injection at one occasion per subject.
Biological: Influenza vaccine
Other Name: Vaxigrip, Vaxigrip Tetra

Placebo Comparator: Drug: placebo
Saline administered as a deep subcutaneous injection at one occasion per subject.
Biological: Placebo



Primary Outcome Measures :
  1. The number of participants with death, a new myocardial infarction or stent thrombosis (first occurring) according to ICD-10 codes. [ Time Frame: 1 year ]
    Composite endpoint of time to all-cause death, a new myocardial infarction or stent thrombosis (first occurring).


Secondary Outcome Measures :
  1. The number of participants with stroke according to ICD-10 codes. [ Time Frame: 1 year ]
    Time to stroke will be registered.

  2. The number of participants with hospitalization for heart failure according to ICD-10 codes. [ Time Frame: 1 year ]
    Time to hospitalization for heart failure will be assessed.

  3. Length of hospital stay per participant. [ Time Frame: Pertains only to hospital stay at baseline. Realistic time frame: till 2 weeks ]
    Assessed by e-health records.

  4. The number of participants with: death, a new myocardial infarction or stent thrombosis assessed separately for each diagnosis according ICD-10 codes. [ Time Frame: 1 year ]
    Death, a new myocardial infarction or stent thrombosis will be reported as separate secondary endpoints.

  5. The number of participants with: cardiovascular death. [ Time Frame: 1 year ]
    Cardiovascular death will be reported as a separate secondary endpoint.


Other Outcome Measures:
  1. The primary and secondary outcomes assessed beyond 1 year [ Time Frame: 5 years ]
    These outcomes will be considered exploratory only.



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

Inclusion Criteria:

  • Patients with a diagnosis of ST-elevation myocardial infarction (STEMI) or
  • Patients with a diagnosis of non-STEMI and
  • A finalized coronary angiography/PCI.
  • Male or female subjects ≥18 years.
  • Written informed consent.

Exclusion Criteria:

  • Influenza vaccination within 12 months prior to inclusion or anticipating to be vaccinated during the current influenza season.
  • Indication for influenza vaccination for some indication other than myocardial infarction.
  • Severe allergy to eggs or previous allergic reaction to influence vaccine.
  • Suspicion of febrile illness or acute, ongoing infection.
  • Hypersensitivity to the active substances or ingredients of Vaxigrip or against any residues, such as eggs (ovalbumin or chicken proteins), neomycin, formaldehyde and octoxinol.
  • Subjects with endogenic or iatrogenic immunosuppression that may result in reduced immunization response.
  • Inability to provide informed consent.
  • Age below 18 years.
  • Previous randomization in the IAMI trial.

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): NCT02831608


Contacts
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Contact: Ole Frobert, MD, PhD 0046 19 602 54 13 ole.frobert@regionorebrolan.se
Contact: Lotta Mazouch 0046 85 85 857 75 lotta.mazouch@karolinska.se

Locations
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Australia, New South Wales
Blacktown Hospital Recruiting
Sydney, New South Wales, Australia
Contact: Timothy C Tan, MD, MBBS       timothy.tan9@gmail.com   
Bangladesh
National Heart Foundation and Research Institute (NHFH) Recruiting
Dhaka, Bangladesh
Contact: Fazila Tun-Nesa Malik, Prof       fazilamalik@yahoo.com   
National Institute of Cardiovascular Diseases (NICVD) Recruiting
Dhaka, Bangladesh
Contact: AKM Monwarul Islam, Dr       drmonwarbd@yahoo.com   
Czechia
St. Anne University Hospital Recruiting
Brno, Czechia
Contact: Ota Hlinomaz, MD, PhD       hlinomaz@univmed.cz   
Principal Investigator: Ota Hlinomaz, MD, PhD         
2nd Department of Internal Cardiovascular Medicine, General University Hospital in Prague Not yet recruiting
Praha, Czechia
Contact: Štěpán Jeřábek, MD       Stepan.Jerabek2@vfn.cz   
Principal Investigator: Štěpán Jeřábek, MD         
University Hospital Kralovske Vinohrady Recruiting
Praha, Czechia
Contact: Zuzana Motovska, MD, PhD       motovska.zuzana@gmail.com   
Principal Investigator: Zuzana Motovska         
Denmark
Aalborg University Hospital Recruiting
Aalborg, Denmark
Contact: Svend E Jensen, MD, PhD       svend.eggert.jensen@rn.dk   
Principal Investigator: Svend E Jensen, MD, PhD         
Aarhus University Hospital Recruiting
Aarhus, Denmark
Contact: Evald H Christiansen, MD, PhD       evald.christiansen@dadlnet.dk   
Principal Investigator: Evald H Christiansen, MD, PhD         
Bispebjerg Hospital Recruiting
Copenhagen, Denmark
Contact: Søren Galatius, MD, PhD       Soeren.Galatius@regionh.dk   
Principal Investigator: Søren Galatius, MD, PhD         
Rigshospitalet, University of Copenhagen Recruiting
Copenhagen, Denmark
Contact: Thomas Engstrøm, MD, PhD       Thomas.Engstroem@regionh.dk   
Principal Investigator: Thomas Engstrøm, MD, PhD         
Odense University Hospital Recruiting
Odense, Denmark
Contact: Lisette O Jensen, MD, DMSci       okkels@dadlnet.dk   
Principal Investigator: Lisette O Jensen, MD, DMSci         
Latvia
Pauls Stradins Clinical University Hospital Recruiting
Riga, Latvia
Contact: Andrejs Erglis, MD, PhD       a.a.erglis@stradini.lv   
Principal Investigator: Andrejs Erglis, MD, PhD         
Norway
Feiring Clinic Recruiting
Feiring, Norway
Contact: Rasmus Moer, MD, PhD       Rasmus.Moer@lhl.no   
Sweden
Sahlgrenska sjukhuset Recruiting
Göteborg, Sweden
Contact: Oskar Angerås, MD, PhD       oskar.angeras@vgregion.se   
Principal Investigator: Oskar Angerås, MD, PhD         
Jönköping Hospital Recruiting
Jönköping, Sweden
Contact: Jörg Lauermann, MD       jorg.lauermann@rjl.se   
Principal Investigator: Jörg Lauermann, MD         
Karlstad Central Hospital Recruiting
Karlstad, Sweden
Contact: Aydin Toksoz, MD       aydin.toksoz@liv.se   
University Hospital Linkoping Recruiting
Linköping, Sweden
Contact: Lena Jonasson, MD, PhD       lena.jonasson@liu.se   
Skånes universitetssjukhus Recruiting
Lund, Sweden
Contact: Matthias Götberg, MD, PhD       matthias.gotberg@gmail.com   
Danderyds sjukhus Recruiting
Stockholm, Sweden
Contact: Jonas Persson, MD, PhD       jonas.persson@ds.se   
Principal Investigator: Jonas Persson, MD, PhD         
Karolinska University Hospital Recruiting
Stockholm, Sweden
Contact: John Pernow, MD, PhD       John.Pernow@ki.se   
Stockholm South General Hospital Recruiting
Stockholm, Sweden
Contact: Nils Witt, MD, PhD       nils.witt@sll.se   
University Hospital Umeå Recruiting
Umea, Sweden
Contact: Johan Nilsson, MD, PhD       johan.nilsson@umu.se   
Uppsala University Hospital Recruiting
Uppsala, Sweden
Contact: Robert K Sevcik, MD       robert.sevcik@akademiska.se   
Principal Investigator: Robert Sevcik, MD         
Centrallasarettet Recruiting
Västerås, Sweden
Contact: Amra Kåregren, MD       amra.karegren@ltv.se   
Principal Investigator: Amra Kåregren, MD         
United Kingdom
Victoria Hospital Recruiting
Kirkcaldy, Fife, United Kingdom
Contact: Mark Francis, MD       cmarkfrancis@nhs.net   
Aberdeen Royal Infirmary Recruiting
Aberdeen, United Kingdom
Contact: Duncan Hogg, MD       duncanhogg@nhs.net   
Ninewells Hospital Recruiting
Dundee, United Kingdom
Contact: Thomas Martin, MD       thomasmartin@nhs.net   
Royal Infirmary of Edinburg Recruiting
Edinburgh, United Kingdom
Contact: Martin Denvir, MD       Martin.Denvir@ed.ac.uk   
Golden Jubilee National Hospital Recruiting
Glasgow, United Kingdom
Contact: Keith G Oldroyd, MD       keith.oldroyd@nhs.net   
Hairmyres Hospital Recruiting
Glasgow, United Kingdom
Contact: David Macdougall, MD       David.Macdougall@lanarkshire.scot.nhs.uk   
Sponsors and Collaborators
Ole Frobert, MD, PhD
Swedish Heart Lung Foundation
Sanofi Pasteur, a Sanofi Company
Uppsala University
Lytics

Publications:
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Responsible Party: Ole Frobert, MD, PhD, MD, PhD, Region Örebro County
ClinicalTrials.gov Identifier: NCT02831608     History of Changes
Other Study ID Numbers: IAMI-2014
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Heart Failure
Influenza, Human
Infarction
Myocardial Infarction
Heart Diseases
Cardiovascular Diseases
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs