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REgister of Myocardial Infarction Patients Treated by the NOVAra STE-MI Network (RENOVAMI)

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ClinicalTrials.gov Identifier: NCT01760382
Recruitment Status : Unknown
Verified March 2015 by Lupi Alessandro, Azienda Ospedaliero Universitaria Maggiore della Carita.
Recruitment status was:  Recruiting
First Posted : January 4, 2013
Last Update Posted : March 26, 2015
Sponsor:
Information provided by (Responsible Party):
Lupi Alessandro, Azienda Ospedaliero Universitaria Maggiore della Carita

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Myocardial infarction (MI) outcomes strictly depend on the time to reponed the infarct-related coronary artery. Networks have been activated in the last years in many countries to achieve fast track access of patients with ST-elevation MI to hospital with h24 primary PCI availability or directly to Cath Labs. From 2011 a regional STEMI network have been formally activated in Piedmont. The aim of our registry is to monitor the activity of the STEMI network in the large suburban area of Novara (population of about 800.000 subjects).

Condition or disease Intervention/treatment
Acute Myocardial Infarction Device: Primary PCI

Detailed Description:

Myocardial infarction (MI) outcomes strictly depend on the time to reponed the infarct-related coronary artery. Networks have been activated in the last years in many countries to achieve fast track access of patients with ST-elevation MI to hospital with h24 primary PCI availability or directly to Cath Labs. From 2011 a regional STEMI network have been formally activated in Piedmont. The aim of our registry is to monitor the activity of the STEMI network in the large suburban area of Novara (population of about 800.000 subjects).

Novara STEMI network depends on the 118 service (the same of 911 in USA). When a call for suspected MI is processed, an Ambulance capable of transmitting a 12D ECG to the Hub Center is sent to the patient domicile. If the ECG and history suggest STEMI and transport time <90min, the patient is given aspirin and sent to Hub Hospital for primary PCI. If transport time is estimated >90min thrombolysis with TNK is performed in ambulance and the patient is sent to Hub Hospital for rescue PCI or re-evaluation in case of reperfusion.

Inclusion criteria: all patients with STEMI admitted to Novara Hospital (3rd level Hub with Cardiac Surgery Facility). No exclusion criteria.

Patients will be divided for comparisons in 2 groups (Group A: people admitted to hospital through the STEMI network. Group B: people admitted for STEMI through the Emergency department of the Novara Hospital or via secondary trasports regulated by Spoke Hospitals).

Quality factors: recording of time from symptoms onset and 1st medical contact, time from 1st medical contact and coronary angiography (door to needle time) and time from 1st medical contact and mechanical reperfusion (door to balloon time), angiographic indexes of reperfusion (baseline and postprocedural TIMI flow, blush grade, corrected TIMI frame count), trends for ST elevation resolution,trends for troponin and CK-MB dismission, baseline and postprocedural echocardiography. Clinical outcomes will be successful reperfusion, in-hospital cardiac mortality, in-hospital reinfarction and in-hospital stent thrombosis. Moreover patients will be followed up clinically for at least 1 year (outcomes: cardiac mortality, reinfarction, symptoms/ischemia driven target vessel revascularization).


Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 700 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: REgister of Myocardial Infarction Patients Treated by the NOVAra STE-MI Network
Study Start Date : January 2011
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
STEMI network Primary PCI patients
Patients with STEMI brought to the Hub Hospital by the STEMI network ambulance and treated by primary PCI.
 Device: Primary PCI
mechanical reopening of the STEMI-related coronary artery by PTCA, with or without coronary stent implantation
STEMI Hospital ED Primary PCI patients
Patients with STEMI who reached by themselves the Hub Hospital, where they were admitted for STEMI and tretated by Primary PCI
 Device: Primary PCI
mechanical reopening of the STEMI-related coronary artery by PTCA, with or without coronary stent implantation


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Successful reperfusion [ Time Frame: 1 day ]
    Successful reperfusion of the infarct related artery according to both clinical (>70% reduction of ST elevation 90min after primary PCI, in comparison to baseline) and angiographic criteria (restoration of TIMI 3 flow with blush grade at least 2).


Secondary Outcome Measures :
  1. In Hospital Cardiac Mortality [ Time Frame: 1 week ]
    In Hospital death for cardiac causes

  2. In hospital myocardial infarction [ Time Frame: 1 week ]
    In hospital new myocardial infarction described as new episode of chest pain with new q waves on ECG and/or new release (secondary peak) of troponin/CK-MB

  3. In hospital stent thrombosis [ Time Frame: 1 week ]
    In hospital thrombosis of the stent implanted in the STEMI-related artery


Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with chest pain or equivalents (dyspnea, epigastrial pain) and ST segmnent elevation on more 2 or more contiguous ECG leads
Criteria

Inclusion Criteria:

  • chest pain or equivalents (dyspnea, epigastrial pain) within 12 hours from onset (also after 12 hours if patient still symptomatic)
  • ST segmnent elevation on more 2 or more contiguous ECG leads
  • reperfusion treatment by primary PCI

Exclusion Criteria:

  • symptoms beginning more than 12 hours before (with patient asymptomatic)
  • survival estimated < 6 months according to the treating physician
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01760382


Contacts
Contact: ALESSANDRO LUPI, M.D. +393495643838 lupialessandro1@tin.it

Locations
Italy
Azienda Ospedaliero Universitaria Maggiore della Carita Recruiting
Novara, Piedmont, Italy, 28100
Contact: Alessandro Lupi, M.D.    +393495643838    lupialessandro1@tin.it   
Sponsors and Collaborators
Azienda Ospedaliero Universitaria Maggiore della Carita
Investigators
Principal Investigator: Alessandro Lupi, M.D. Azienda Ospedaliero Universitaria Maggiore della Carita
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Lupi Alessandro, Principal investigator, Azienda Ospedaliero Universitaria Maggiore della Carita
ClinicalTrials.gov Identifier: NCT01760382     History of Changes
Other Study ID Numbers: RENOVAMI01
First Posted: January 4, 2013    Key Record Dates
Last Update Posted: March 26, 2015
Last Verified: March 2015

Keywords provided by Lupi Alessandro, Azienda Ospedaliero Universitaria Maggiore della Carita:
Acute myocardial infarction
ST elevation myocardial infarction
primary PCI
 reperfusion therapy
angioplasty
stent

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases