An observational study in Myocardial Infarction and Acute Coronary Syndrome, sponsored by Complexo Hospitalario Universitario de A Coruña. Completed at 1 site in Spain. Per ClinicalTrials.gov, last updated 2017-07-19.
Sponsored by Complexo Hospitalario Universitario de A Coruña · Observational
This is a multicenter retrospective observational study with STEMI (ST Elevation Myocardial Infarction) patients who have been treated in the northern Galician Hospitals. The study tries to verify if the implantation of the PROGALIAM (Galician Assistance Program Acute Myocardial Infarction) has supposed a progress in the quality and expectancy of life of AMI patients in the north area of Galicia.
The study will recruit STEMI patients according to the third consensus definition of myocardial infarction type I.
It will include all patients who meet these criteria regardless of other demographic or clinical circumstances. There is not exclusion criteria defined for this population.
The study presents the following objectives:
Primary Objectives:
To compare morbidity rates between pre and post-PROGALIAM periods in major adverse cardiac events. The outcome to study is a composite of death, reinfarction, heart failure and major bleeding at 30 days, one year and long term follow-up.
Secondary Objectives To compare Pre and post PROGALIAM periods regarding;
Study Design This is a multicenter retrospective observational study with STEMI patients who have been treated in the northern Galician Hospitals.
According to data obtained in MASCARA register where approximately 38% of ACS patients present ST segment elevation, the estimated sample size would therefore be about 6100 patients.
*Inclusion, Exclusion Criteria and rational The study will recruit STEMI patients according to the third consensus definition of myocardial infarction type I. It was recently published.
It will include all patients who meet these criteria regardless of other demographic or clinical circumstances. There is not exclusion criteria defined for this population.
*Statistical analysis Categorical variables will be presented in percentage, calculated from the whole valid information. The CI will be of 95 %. Quantitative variables will be presented as mean ± standard deviation or median (interquartile range) according to a normal underlying distribution or not. Initially a univariate analysis will be done.
The comparison of quantitative variables means will be done by student´s t-test in case of normality or by nonparametric tests in the opposite case. Categorical variables will be analyzed by the Chi square test. Survival will be analyzed by Kaplan-Meier curves. The comparison between pre and post PROGALIAM curves will be done by a log-rank test. A p \<0.05 will be considered statistically significant for two-tailed tests.
Also there are plans to carry out a multivariate analysis. There will be a quantification of the adjusted effect on mortality due to the introduction of PROGALIAM by a Cox Proportional Hazards model. It will be defined the best model to predict this adjusted event by independent variables which can demonstrate an impact on death outcome in the univariate model and by those independent variables in which significant differences are observed between the pre and post PROGALIAM population. The investigators will verify if the implementation of the PROGALIAM is an independent predictor of survival and the impact that generates in the model.
A p \<0.05 result will be considered statistically significant in a two-tailed test.
To carry out these analyses it will be necessary to have statistical software like SPSS and/or SAS.
2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.
This study's enrollment of 5,937 is above the median of 500 across 983 observational studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →Complexo Hospitalario Universitario de A Coruña is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
The study will gather patients with STEMI (ST segment Elevation Myocardial Infarction) according to the third consensus definition of myocardial infarction treated at Northern Galician Network of Acute Myocardial Infarction.
Exclusion Criteria:
Patients treated for myocardial infarction before the implementation of the network for acute myocardial infarction care (2001 to 2005).
Patients treated for myocardial infarction after the implementation of the network for acute myocardial infarction care (2005 to 2011).
Death Pre vs Post PROGALIAM implantation (measured from medical records)
A composite of total death and cardiovascular death
Time frame: 30 days
MACE Death Pre vs Post PROGALIAM implantation (Mayor Adverse Cardiovascular Events) (measured from medical records)
A composite of death, reinfarction, heart failure and bleeding
Time frame: 30 days
Death Pre vs Post PROGALIAM implantation (measured from medical records)
A composite of total death and cardiovascular death
Time frame: one year
MACE Death Pre vs Post PROGALIAM implantation (Mayor Adverse Cardiovascular Events) (measured from medical records)
A composite of death, reinfarction, heart failure and bleeding
Time frame: one year
Overall mortality Death Pre vs Post PROGALIAM implantation (measured from medical records)
Time frame: 30 days, One year
Reinfarction Death Pre vs Post PROGALIAM implantation (measured from medical records)
Time frame: 30 days, one year
Hospital Mayor bleeding Death Pre vs Post PROGALIAM implantation (measured from medical records)
Time frame: 30 days
Vascular Complications Death Pre vs Post PROGALIAM implantation (measured from medical records)
Time frame: 30 days
Heart failure Death Pre vs Post PROGALIAM implantation (measured from medical records)
Time frame: 30 days, one year
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Complexo Hospitalario Universitario de A Coruña