NCT02501070

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,937

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 17, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

July 19, 2017

Status Verified

July 1, 2017

Enrollment Period

1.5 years

First QC Date

July 9, 2015

Last Update Submit

July 18, 2017

Conditions

Myocardial InfarctionAcute Coronary Syndrome

Keywords

Percutaneous Coronary InterventionAngioplastyStentCommunity Networks

Outcome Measures

Primary Outcomes (4)

  • Death Pre vs Post PROGALIAM implantation (measured from medical records)

    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)

    A composite of death, reinfarction, heart failure and bleeding

    30 days

  • Death Pre vs Post PROGALIAM implantation (measured from medical records)

    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)

    A composite of death, reinfarction, heart failure and bleeding

    one year

Secondary Outcomes (5)

  • Overall mortality Death Pre vs Post PROGALIAM implantation (measured from medical records)

    30 days, One year

  • Reinfarction Death Pre vs Post PROGALIAM implantation (measured from medical records)

    30 days, one year

  • Hospital Mayor bleeding Death Pre vs Post PROGALIAM implantation (measured from medical records)

    30 days

  • Vascular Complications Death Pre vs Post PROGALIAM implantation (measured from medical records)

    30 days

  • Heart failure Death Pre vs Post PROGALIAM implantation (measured from medical records)

    30 days, one year

Study Arms (2)

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).

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario de A Coruña

A Coruña, 15006, Spain

Location

Related Publications (14)

  • 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 M, Opolski G, Ostojic M, Radovanovic D, De Servi S, Stenestrand U, Studencan M, Tubaro M, Vasiljevic Z, Weidinger F, Witkowski A, Zeymer U; European Association for Percutaneous Cardiovascular Interventions. Reperfusion therapy for ST elevation acute myocardial infarction in Europe: description of the current situation in 30 countries. Eur Heart J. 2010 Apr;31(8):943-57. doi: 10.1093/eurheartj/ehp492. Epub 2009 Nov 19.

    PMID: 19933242RESULT

  • 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 the Czech evaluation of acute coronary syndromes in hospitalized patients (CZECH) registry. Int J Cardiol. 2007 Jul 10;119(2):212-9. doi: 10.1016/j.ijcard.2007.02.036. Epub 2007 Apr 18.

    PMID: 17442424RESULT

  • 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.

    PMID: 21187184RESULT

  • 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 A, Matchar DB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Soliman EZ, Sorlie PD, Sotoodehnia N, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2012 update: a report from the American Heart Association. Circulation. 2012 Jan 3;125(1):e2-e220. doi: 10.1161/CIR.0b013e31823ac046. Epub 2011 Dec 15. No abstract available.

    PMID: 22179539RESULT

  • 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, treatment, and outcome of patients with ACS in Europe and the Mediterranean Basin in 2004. Eur Heart J. 2006 Oct;27(19):2285-93. doi: 10.1093/eurheartj/ehl196. Epub 2006 Aug 14.

    PMID: 16908490RESULT

  • Jernberg T, Johanson P, Held C, Svennblad B, Lindback 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: 10.1001/jama.2011.522.

    PMID: 21521849RESULT

  • Marrugat J, Elosua R, Marti 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. doi: 10.1016/s0300-8932(02)76611-6. Spanish.

    PMID: 11975899RESULT

  • 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, Blomstrom-Lundqvist C, Borger MA, Di Mario C, Dickstein K, Ducrocq G, Fernandez-Aviles F, Gershlick AH, Giannuzzi P, Halvorsen S, Huber K, Juni P, Kastrati A, Knuuti J, Lenzen MJ, Mahaffey KW, Valgimigli M, van 't Hof A, Widimsky P, Zahger D. ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation. Eur Heart J. 2012 Oct;33(20):2569-619. doi: 10.1093/eurheartj/ehs215. Epub 2012 Aug 24. No abstract available.

    PMID: 22922416RESULT

  • 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. doi: 10.1136/heartjnl-2011-300558. Epub 2011 Dec 6.

    PMID: 22147900RESULT

  • Estevez-Loureiro R, Calvino-Santos R, Vazquez JM, Barge-Caballero E, Salgado-Fernandez J, Pineiro M, Freire-Tellado M, Varela-Portas J, Martinez L, Gomez S, Rodriguez JA, Vazquez N, Castro-Beiras A. Safety and feasibility of returning patients early to their originating centers after transfer for primary percutaneous coronary intervention. Rev Esp Cardiol. 2009 Dec;62(12):1356-64. doi: 10.1016/s1885-5857(09)73529-7.

    PMID: 20038401RESULT

  • Barge-Caballero E, Vazquez-Rodriguez JM, Estevez-Loureiro R, Calvino-Santos R, Salgado-Fernandez J, Aldama-Lopez G, Pinon-Esteban P, Flores-Rios X, Campo-Perez R, Rodriguez-Fernandez JA, Lomban-Villanueva JA, Mesias-Prego A, Gutierrez-Cortes JM, Gonzalez-Juanatey C, Portela C, Iglesias-Vazquez A, Varela-Portas Marino J, Vazquez-Gonzalez N, Castro-Beiras A. Primary angioplasty in Northern Galicia: care changes and results following implementation of the PROGALIAM protocol. Rev Esp Cardiol (Engl Ed). 2012 Apr;65(4):341-9. doi: 10.1016/j.recesp.2011.11.003. Epub 2012 Feb 10.

    PMID: 22325936RESULT

  • 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, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasche P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S. Third universal definition of myocardial infarction. Circulation. 2012 Oct 16;126(16):2020-35. doi: 10.1161/CIR.0b013e31826e1058. Epub 2012 Aug 24. No abstract available.

    PMID: 22923432RESULT

  • Ferreira-Gonzalez I, Permanyer-Miralda G, Marrugat J, Heras M, Cunat J, Civeira E, Aros F, Rodriguez JJ, Sanchez PL, Bueno H; MASCARA study research team. MASCARA (Manejo del Sindrome Coronario Agudo. Registro Actualizado) study. General findings. Rev Esp Cardiol. 2008 Aug;61(8):803-16. English, Spanish.

    PMID: 18684363RESULT

  • Aldama G, Lopez M, Santas M, Flores X, Pinon P, Salgado J, Calvino R, Vazquez N, Mesias A, Gonzalez-Juanatey C, Muniz J, Vazquez JM. Impact on mortality after implementation of a network for ST-segment elevation myocardial infarction care. The IPHENAMIC study. Rev Esp Cardiol (Engl Ed). 2020 Aug;73(8):632-642. doi: 10.1016/j.rec.2019.09.031. Epub 2020 Feb 1. English, Spanish.

    PMID: 32014432DERIVED

MeSH Terms

Conditions

Myocardial InfarctionAcute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Guillermo Aldama, M.D.

    Hospital Universitario de A Coruña

    STUDY DIRECTOR

  • Melisa Santás, M.D.

    Hospital Universitario Lucus Augusti

    PRINCIPAL INVESTIGATOR

  • Manuel Lopez, M.D.

    Hospital Arquitecto Marcide

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Interventional Cardiologist

Study Record Dates

First Submitted

July 9, 2015

First Posted

July 17, 2015

Study Start

April 1, 2015

Primary Completion

October 1, 2016

Study Completion

November 1, 2016

Last Updated

July 19, 2017

Record last verified: 2017-07

Locations

ES(1)