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

Myocardial Infarction Clinical Trial

— iPHENAMIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02501070
• Other study ID #: D5130C00091
• Status: Completed
• Phase: N/A
• First received: July 9, 2015
• Last updated: July 18, 2017
• Start date: April 2015
• Est. completion date: November 2016

Study information

• Verified date: July 2017
• Source: Complexo Hospitalario Universitario de A Coruña
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5937
• Est. completion date: November 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Infarction
• Myocardial Infarction

Locations

Country	Name	City	State
Spain	Hospital Universitario de A Coruña	A Coruña

Sponsors (3)

Lead Sponsor	Collaborator
Complexo Hospitalario Universitario de A Coruña	Hospital Arquitecto Marcide, Hospital Universitario Lucus Augusti

Country where clinical trial is conducted

Spain, 

References & Publications (13)

Barge-Caballero E, Vázquez-Rodríguez JM, Estévez-Loureiro R, Calviño-Santos R, Salgado-Fernández J, Aldama-López G, Piñón-Esteban P, Flores-Ríos X, Campo-Pérez R, Rodríguez-Fernández JÁ, Lombán-Villanueva JA, Mesías-Prego A, Gutiérrez-Cortés JM, González- — View Citation

Estévez-Loureiro R, Calviño-Santos R, Vázquez JM, Barge-Caballero E, Salgado-Fernández J, Piñeiro M, Freire-Tellado M, Varela-Portas J, Martínez L, Gómez S, Rodríguez JA, Vázquez N, Castro-Beiras A. Safety and feasibility of returning patients early to th — View Citation

Ferreira-González I, Permanyer-Miralda G, Marrugat J, Heras M, Cuñat J, Civeira E, Arós F, Rodríguez JJ, Sánchez PL, Bueno H; MASCARA study research team. MASCARA (Manejo del Síndrome Coronario Agudo. Registro Actualizado) study. General findings. Rev Esp — View Citation

Jernberg T, Johanson P, Held C, Svennblad B, Lindbäck J, Wallentin L; SWEDEHEART/RIKS-HIA. Association between adoption of evidence-based treatment and survival for patients with ST-elevation myocardial infarction. JAMA. 2011 Apr 27;305(16):1677-84. doi: — View Citation

Mamas MA, Ratib K, Routledge H, Fath-Ordoubadi F, Neyses L, Louvard Y, Fraser DG, Nolan J. Influence of access site selection on PCI-related adverse events in patients with STEMI: meta-analysis of randomised controlled trials. Heart. 2012 Feb;98(4):303-11 — View Citation

Mandelzweig L, Battler A, Boyko V, Bueno H, Danchin N, Filippatos G, Gitt A, Hasdai D, Hasin Y, Marrugat J, Van de Werf F, Wallentin L, Behar S; Euro Heart Survey Investigators. The second Euro Heart Survey on acute coronary syndromes: Characteristics, tr — View Citation

Marrugat J, Elosua R, Martí H. [Epidemiology of ischaemic heart disease in Spain: estimation of the number of cases and trends from 1997 to 2005]. Rev Esp Cardiol. 2002 Apr;55(4):337-46. Spanish. — View Citation

McManus DD, Gore J, Yarzebski J, Spencer F, Lessard D, Goldberg RJ. Recent trends in the incidence, treatment, and outcomes of patients with STEMI and NSTEMI. Am J Med. 2011 Jan;124(1):40-7. doi: 10.1016/j.amjmed.2010.07.023. — View Citation

Roger VL, Go AS, Lloyd-Jones DM, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli — View Citation

Task Force on the management of ST-segment elevation acute myocardial infarction of the European Society of Cardiology (ESC), Steg PG, James SK, Atar D, Badano LP, Blömstrom-Lundqvist C, Borger MA, Di Mario C, Dickstein K, Ducrocq G, Fernandez-Aviles F, G — View Citation

Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction, Katus HA, Lindahl B, Morrow DA, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow RO, P — View Citation

Widimsky P, Wijns W, Fajadet J, de Belder M, Knot J, Aaberge L, Andrikopoulos G, Baz JA, Betriu A, Claeys M, Danchin N, Djambazov S, Erne P, Hartikainen J, Huber K, Kala P, Klinceva M, Kristensen SD, Ludman P, Ferre JM, Merkely B, Milicic D, Morais J, Noc — View Citation

Widimsky P, Zelizko M, Jansky P, Tousek F, Holm F, Aschermann M; CZECH investigators. The incidence, treatment strategies and outcomes of acute coronary syndromes in the "reperfusion network" of different hospital types in the Czech Republic: results of t — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death Pre vs Post PROGALIAM implantation (measured from medical records)	A composite of total death and cardiovascular death	30 days
Primary	MACE Death Pre vs Post PROGALIAM implantation (Mayor Adverse Cardiovascular Events) (measured from medical records)	A composite of death, reinfarction, heart failure and bleeding	30 days
Primary	Death Pre vs Post PROGALIAM implantation (measured from medical records)	A composite of total death and cardiovascular death	one year
Primary	MACE Death Pre vs Post PROGALIAM implantation (Mayor Adverse Cardiovascular Events) (measured from medical records)	A composite of death, reinfarction, heart failure and bleeding	one year
Secondary	Overall mortality Death Pre vs Post PROGALIAM implantation (measured from medical records)		30 days, One year
Secondary	Reinfarction Death Pre vs Post PROGALIAM implantation (measured from medical records)		30 days, one year
Secondary	Hospital Mayor bleeding Death Pre vs Post PROGALIAM implantation (measured from medical records)		30 days
Secondary	Vascular Complications Death Pre vs Post PROGALIAM implantation (measured from medical records)		30 days
Secondary	Heart failure Death Pre vs Post PROGALIAM implantation (measured from medical records)		30 days, one year