Myocardial InfarctioniPHENAMICNCT02501070
Impact on Public HEalth of a Network in Acute Myocardial Infarction Care
An observational study of Myocardial Infarction and Acute Coronary Syndrome, run by Complexo Hospitalario Universitario de A Coruña at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myocardial Infarction, Acute Coronary Syndrome
- How many people
- 5,937 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2015to Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- All patients suffering STEMI (ST segment Elevation Myocardial Infarction) treated at Northern Galician Network of Acute Myocardial Infarction
Who cannot join
- No exclusion Criteria
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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;
- 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.
- Pre-PROGALIAM period: January 2001- May 2005
- 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.
- Conditions
- Myocardial Infarction, Acute Coronary Syndrome
- Keywords
- Percutaneous Coronary Intervention, Angioplasty, Stent, Community Networks
- Medical subject headings
- Myocardial Infarction, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Death Pre vs Post PROGALIAM implantation (measured from medical records)
A composite of total death and cardiovascular death
Measured: 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
Measured: 30 days
Death Pre vs Post PROGALIAM implantation (measured from medical records)
A composite of total death and cardiovascular death
Measured: 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
Measured: one year
Secondary outcomes (5)
Overall mortality Death Pre vs Post PROGALIAM implantation (measured from medical records)
Measured: 30 days, One year
Reinfarction Death Pre vs Post PROGALIAM implantation (measured from medical records)
Measured: 30 days, one year
Hospital Mayor bleeding Death Pre vs Post PROGALIAM implantation (measured from medical records)
Measured: 30 days
Vascular Complications Death Pre vs Post PROGALIAM implantation (measured from medical records)
Measured: 30 days
Heart failure Death Pre vs Post PROGALIAM implantation (measured from medical records)
Measured: 30 days, one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2015 (estimated)
- Study startApr 2015
- Primary completionOct 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5,937 participants (actual)
Sponsor and investigators
- Lead sponsor
- Complexo Hospitalario Universitario de A Coruña
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Lucus Augusti, Hospital Arquitecto Marcide
- Responsible party
- Principal investigator, Guillermo Aldama, Complexo Hospitalario Universitario de A Coruña
- Investigators
- Guillermo Aldama, M.D., Study director, Hospital Universitario de A CoruñaMelisa Santás, M.D., Principal investigator, Hospital Universitario Lucus AugustiManuel Lopez, M.D., Principal investigator, Hospital Arquitecto Marcide
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02501070
- Sponsor's protocol ID
- D5130C00091
- Acronym
- iPHENAMIC
- Status last verified
- Jul 2017
- First submitted
- 9 Jul 2015
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19933242Widimsky 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.
PubMed 17442424McManus 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.
PubMed 21187184Roger 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.
PubMed 22179539Mandelzweig 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.
PubMed 16908490Jernberg 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.
PubMed 21521849Marrugat 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.
PubMed 11975899Task 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.
PubMed 22922416Mamas 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.
PubMed 22147900Estevez-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.
PubMed 20038401Barge-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.
PubMed 22325936Thygesen 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.
PubMed 22923432Ferreira-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.
PubMed 18684363Aldama 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.
PubMed 32014432
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02501070
- Acronym / sponsor ID
- iPHENAMIC / D5130C00091
- Conditions
- Myocardial Infarction, Acute Coronary Syndrome
- Keywords
- Percutaneous Coronary Intervention, Angioplasty, Stent, Community Networks
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,937 participants (actual)
- Lead sponsor
- Complexo Hospitalario Universitario de A CoruñaUniversity, hospital or other
- Collaborators
- Hospital Universitario Lucus Augusti, Hospital Arquitecto Marcide
- Study start
- Apr 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 17 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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;
- 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.
- Pre-PROGALIAM period: January 2001- May 2005
- 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All patients suffering STEMI (ST segment Elevation Myocardial Infarction) treated at Northern Galician Network of Acute Myocardial Infarction
Key exclusion criteria (1 listed)
- No exclusion Criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Death Pre vs Post PROGALIAM implantation (measured from medical records)
Time frame: 30 days
A composite of total death and cardiovascular death
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
Death Pre vs Post PROGALIAM implantation (measured from medical records)
Time frame: one year
A composite of total death and cardiovascular death
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
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
- Results publication: PubMed 19933242Widimsky 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.
- Results publication: PubMed 17442424Widimsky 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.
- Results publication: PubMed 21187184McManus 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.
- Results publication: PubMed 22179539Roger 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.
- Results publication: PubMed 16908490Mandelzweig 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.
- Results publication: PubMed 21521849Jernberg 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.
- Results publication: PubMed 11975899Marrugat 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.
- Results publication: PubMed 22922416Task 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.
- Results publication: PubMed 22147900Mamas 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.
- Results publication: PubMed 20038401Estevez-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.
- Results publication: PubMed 22325936Barge-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.
- Results publication: PubMed 22923432Thygesen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillermo Aldama, M.D. study director
Hospital Universitario de A Coruña
Melisa Santás, M.D. principal investigator
Hospital Universitario Lucus Augusti
Manuel Lopez, M.D. principal investigator
Hospital Arquitecto Marcide
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction and Acute Coronary Syndrome, run by Complexo Hospitalario Universitario de A Coruña at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death Pre vs Post PROGALIAM implantation (measured from medical records) (time frame: 30 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02501070, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2017.