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

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: 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

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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.



Information from the National Library of Medicine

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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
Show Show 30 study locations
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    
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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Influenza, Human
Myocardial Infarction
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