Drugs as risk factors of unexplained sudden cardiac death (SCD). A case-control study

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/7719
• EU PAS number:
  EUPAS7718
• Study ID:
  7719
• Official title and acronym:
  Drugs as risk factors of unexplained sudden cardiac death (SCD). A case-control study
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  The main objective of the study is to determine the risk of unexplained sudden cardiac death (SCD) associated with proarrhythmic drug use. Secondary objectives are 1) to describe and to compare with controls the main characteristics (demographic and clinical) of patients with unexplained SCD, 2) to estimate the incidence (overall and by age group and gender) of unexplained SCD, and 3) to determine the risk of unexplained SCD associated with pro-arrhythmic drug use in patients with co-morbid cadiovascular diseases.Methodology: A community-based matched case-control study will be performed. Cases will be identified from the Institute of Legal Medicine of Catalonia and index date-, health centre-, gender- and age-matched controls will be obtained from the epidemiological database of primary care medical records (SIDIAP). The study will include all suddenly died patients who have had an autopsy that foundno clear cause of death occurred in the last 4 years in the study area in Catalonia. The information on drug exposure, co-variables and risk factors of both cases and controls will be also obtained from the SIDIAP database. The odds ratio and 95% confidence intervals of all groups of drugs potentially causing unexplained SCD will be calculated using techniques of conditional logistic regression analysis.
• Study status:
  Planned

Research institution and networks

Institutions

University of Girona

Translab Research Group

Study timelines

Date when funding contract was signed

Planned: 15/01/2014

Actual: 15/01/2014

Study start date

Planned: 15/10/2014

Date of final study report

Planned: 31/01/2017

Sources of funding

Other

More details on funding

Instituto de Salud Carlos III

Study protocol

Initial protocol

FIS_2013_V2

Regulatory

• Was the study required by a regulatory body?:
  No