Study identification

PURI

https://redirect.ema.europa.eu/resource/36567

EU PAS number

EUPAS36560

Study ID

36567

Official title and acronym

INFLUENZA AND ACUTE MYOCARDIAL INFARCTION IN THE COMMUNITY OF MADRID: A RETROSPECTIVE ECOLOGICAL TIME-SERIES STUDY (2013-2018) (FLU-AMI-ECO)

DARWIN EU® study

No

Study countries

Spain

Study description

Influenza and cold can explain the increased incidence of acute myocardial infarction (AMI) during the winter but, since they are closely related in temperate regions, their relative contribution is not clear. Influenza can be associated to type 1 and type 2 AMI, but few studies have investigated its relationship with ST-elevation AMI (STEMI). The aim of this study is to assess the temporal relationship of flu epidemic with the incidence of STEMI in the region of Madrid (Spain) using the data from the "Código Infarto Registry" from 2013 to 2018. Only STEMI with a demonstrated culprit lesion (type 1 AMI) will be included. The IR of influenza and temperature during five flu epidemic periods (from 40th week through 20th week next year) will be obtained from official records. A time-series analysis will be carried out using quasi-Poisson regression models and distributed lag-nonlinear models, including stratified analyses by sex and age (<65 and >=65 years). The IR of STEMI according to flu vaccination will be explored using data from the STEMI registry and population statistics of vaccination.

Study status

Planned
Research institutions and networks

Institutions

Fundación para la Investigación Biomédica

Contact details

Francisco J de Abajo

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:

Study start date

Planned:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 
Other

More details on funding

Sanofi Pasteur, S.A., Biomedical Research Foundation, Own resources
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable