Impact on Public HEalth of a Network in Acute Myocardial Infarction Care (iPHENAMIC)

July 18, 2017 updated by: Guillermo Aldama, Complexo Hospitalario Universitario de A Coruña

Impact of Implantation of PROGALIAM Network (Galician Program of Care in Acute Myocardial Infarction) in Cardiovascular Health in the Northern Area of Galicia.

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.

Study Overview

Status

Completed

Conditions

Detailed Description

  • Study Hypothesis This study tries to verify if the implantation of the PROGALIAM has supposed a progress in the quality and expectancy of life of AMI patients in the north area of Galicia.
  • Objectives.

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;

1. Overall mortality at 30 days, one year and long term follow up. 2. Reinfarction at 30 days, one year and long term follow up. 3. Heart failure incidence at 30 days, one year and long term follow up 4. Hospital major bleeding and at 30 days. 5. Hospital Vascular complications and at 30 days. 6. Heart failure functional Class at 30 days, one year and long term follow up.

  • Study Design This is a multicenter retrospective observational study with STEMI patients who have been treated in the northern Galician Hospitals.

    1. Pre-PROGALIAM period: January 2001- May 2005
    2. Post-PROGALIAM period: June 2005- December 2011
  • Rational for Sample size Sample size will be constituted by all STEMI cases occurred in both timeframes described above.

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.

Study Type

Observational

Enrollment (Actual)

5937

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • A Coruña, Spain, 15006
        • Hospital Universitario de A Coruna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

  • All patients suffering STEMI (ST segment Elevation Myocardial Infarction) treated at Northern Galician Network of Acute Myocardial Infarction

Exclusion Criteria:

  • No exclusion Criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Pre-PROGALIAM
Patients treated for myocardial infarction before the implementation of the network for acute myocardial infarction care (2001 to 2005).
PROGALIAM
Patients treated for myocardial infarction after the implementation of the network for acute myocardial infarction care (2005 to 2011).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death Pre vs Post PROGALIAM implantation (measured from medical records)
Time Frame: 30 days
A composite of total death and cardiovascular death
30 days
MACE Death Pre vs Post PROGALIAM implantation (Mayor Adverse Cardiovascular Events) (measured from medical records)
Time Frame: 30 days
A composite of death, reinfarction, heart failure and bleeding
30 days
Death Pre vs Post PROGALIAM implantation (measured from medical records)
Time Frame: one year
A composite of total death and cardiovascular death
one year
MACE Death Pre vs Post PROGALIAM implantation (Mayor Adverse Cardiovascular Events) (measured from medical records)
Time Frame: one year
A composite of death, reinfarction, heart failure and bleeding
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall mortality Death Pre vs Post PROGALIAM implantation (measured from medical records)
Time Frame: 30 days, One year
30 days, One year
Reinfarction Death Pre vs Post PROGALIAM implantation (measured from medical records)
Time Frame: 30 days, one year
30 days, one year
Hospital Mayor bleeding Death Pre vs Post PROGALIAM implantation (measured from medical records)
Time Frame: 30 days
30 days
Vascular Complications Death Pre vs Post PROGALIAM implantation (measured from medical records)
Time Frame: 30 days
30 days
Heart failure Death Pre vs Post PROGALIAM implantation (measured from medical records)
Time Frame: 30 days, one year
30 days, one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Complexo Hospitalario Universitario de A Coruña

Collaborators

Hospital Universitario Lucus Augusti
Hospital Arquitecto Marcide

Investigators

  • Study Director: Guillermo Aldama, M.D., Hospital Universitario de A Coruna
  • Principal Investigator: Melisa Santás, M.D., Hospital Universitario Lucus Augusti
  • Principal Investigator: Manuel Lopez, M.D., Hospital Arquitecto Marcide

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

July 9, 2015

First Submitted That Met QC Criteria

July 15, 2015

First Posted (Estimate)

July 17, 2015

Study Record Updates

Last Update Posted (Actual)

July 19, 2017

Last Update Submitted That Met QC Criteria

July 18, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5130C00091

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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