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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01760382
Acronym
RENOVAMI
Enrollment
700
Registered
2013-01-04
Start date
2011-01-31
Completion date
2016-03-31
Last updated
2015-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction

Keywords

Acute myocardial infarction, ST elevation myocardial infarction, primary PCI, reperfusion therapy, angioplasty, stent

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).

Interventions

mechanical reopening of the STEMI-related coronary artery by PTCA, with or without coronary stent implantation

Sponsors

Azienda Ospedaliero Universitaria Maggiore della Carita
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Successful reperfusion1 daySuccessful 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

MeasureTime frameDescription
In Hospital Cardiac Mortality1 weekIn Hospital death for cardiac causes
In hospital myocardial infarction1 weekIn 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 thrombosis1 weekIn hospital thrombosis of the stent implanted in the STEMI-related artery

Countries

Italy

Contacts

Primary ContactALESSANDRO LUPI, M.D.
lupialessandro1@tin.it+393495643838

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026