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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02501070
Recruitment Status : Completed
First Posted : July 17, 2015
Last Update Posted : July 19, 2017
Sponsor:
Collaborators:
Hospital Universitario Lucus Augusti
Hospital Arquitecto Marcide
Information provided by (Responsible Party):
Guillermo Aldama, Complexo Hospitalario Universitario de A Coruña

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.


Condition or disease
Myocardial Infarction Acute Coronary Syndrome

Show Show detailed description

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Study Type : Observational
Actual Enrollment : 5937 participants
Observational Model: Cohort
Time Perspective: Retrospective
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.
Study Start Date : April 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

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).



Primary Outcome Measures :
  1. Death Pre vs Post PROGALIAM implantation (measured from medical records) [ Time Frame: 30 days ]
    A composite of total death and cardiovascular death

  2. 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

  3. Death Pre vs Post PROGALIAM implantation (measured from medical records) [ Time Frame: one year ]
    A composite of total death and cardiovascular death

  4. 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


Secondary Outcome Measures :
  1. Overall mortality Death Pre vs Post PROGALIAM implantation (measured from medical records) [ Time Frame: 30 days, One year ]
  2. Reinfarction Death Pre vs Post PROGALIAM implantation (measured from medical records) [ Time Frame: 30 days, one year ]
  3. Hospital Mayor bleeding Death Pre vs Post PROGALIAM implantation (measured from medical records) [ Time Frame: 30 days ]
  4. Vascular Complications Death Pre vs Post PROGALIAM implantation (measured from medical records) [ Time Frame: 30 days ]
  5. Heart failure Death Pre vs Post PROGALIAM implantation (measured from medical records) [ Time Frame: 30 days, one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02501070


Locations
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Spain
Hospital Universitario de A Coruña
A Coruña, Spain, 15006
Sponsors and Collaborators
Complexo Hospitalario Universitario de A Coruña
Hospital Universitario Lucus Augusti
Hospital Arquitecto Marcide
Investigators
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Study Director: Guillermo Aldama, M.D. Hospital Universitario de A Coruña
Principal Investigator: Melisa Santás, M.D. Hospital Universitario Lucus Augusti
Principal Investigator: Manuel Lopez, M.D. Hospital Arquitecto Marcide
Publications of Results:
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, Menasché 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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Guillermo Aldama, Interventional Cardiologist, Complexo Hospitalario Universitario de A Coruña
ClinicalTrials.gov Identifier: NCT02501070    
Other Study ID Numbers: D5130C00091
First Posted: July 17, 2015    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: July 2017
Keywords provided by Guillermo Aldama, Complexo Hospitalario Universitario de A Coruña:
Percutaneous Coronary Intervention
Angioplasty
Stent
Community Networks
Additional relevant MeSH terms:
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Myocardial Infarction
Acute Coronary Syndrome
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases