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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Azienda Ospedaliero Universitaria Maggiore della Carita
Sponsor:
Information provided by (Responsible Party):
Lupi Alessandro, Azienda Ospedaliero Universitaria Maggiore della Carita
ClinicalTrials.gov Identifier:
NCT01760382
First received: December 30, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

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 Intervention
Acute Myocardial Infarction
Device: Primary PCI

Study Type: Observational [Patient Registry]
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliero Universitaria Maggiore della Carita:

Primary Outcome Measures:
  • Successful reperfusion [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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:
  • In Hospital Cardiac Mortality [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    In Hospital death for cardiac causes

  • In hospital myocardial infarction [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    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

  • In hospital stent thrombosis [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    In hospital thrombosis of the stent implanted in the STEMI-related artery


Estimated Enrollment: 700
Study Start Date: January 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Lupi Alessandro, Principal investigator, Azienda Ospedaliero Universitaria Maggiore della Carita
ClinicalTrials.gov Identifier: NCT01760382     History of Changes
Other Study ID Numbers: RENOVAMI01
Study First Received: December 30, 2012
Last Updated: December 30, 2012
Health Authority: Italy: National Institute of Health

Keywords provided by 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

ClinicalTrials.gov processed this record on October 16, 2014