Clinical trial NCT01760382: REgister of Myocardial Infarction Patients Treated by the NOVAra STE-MI Network
Official title: REgister of Myocardial Infarction Patients Treated by the NOVAra STE-MI Network
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Myocardial Infarction
Keywords: Acute myocardial infarction
ST elevation myocardial infarction
primary PCI
reperfusion therapy
angioplasty
stent
Lead sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita
Sponsor class: OTHER
First posted: 2013-01-04
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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).

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 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

Primary outcomes:
measure: Successful reperfusion
timeFrame: 1 day
Secondary outcomes:
measure: In Hospital Cardiac Mortality
timeFrame: 1 week
measure: In hospital myocardial infarction
timeFrame: 1 week
measure: In hospital stent thrombosis
timeFrame: 1 week
Other outcomes:
Locations:
city: Novara
country: Italy
facility: Azienda Ospedaliero Universitaria Maggiore della Carita
state: Piedmont
Study officials:
affiliation: Azienda Ospedaliero Universitaria Maggiore della Carita
name: Alessandro Lupi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lupi A, Bona RD, Meliga E, Capodanno D, Schaffer A, Bongo AS, Gaudio G, Guasti L, Alexopoulos D, Valgimigli M, Porto I. Early P2Y12 Inhibitors Escalation in Primary PCI Patients: Insights from the RENOVAMI Registry. Thromb Haemost. 2018 May;118(5):852-863. doi: 10.1055/s-0038-1635578. Epub 2018 Apr 4.