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

NCT ID: NCT01760382

Last Updated: 2015-03-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 700 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2016-03-31

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).

Conditions

Acute Myocardial Infarction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

STEMI network Primary PCI patients

Patients with STEMI brought to the Hub Hospital by the STEMI network ambulance and treated by primary PCI.

Primary PCI

Intervention Type: DEVICE

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

Primary PCI

Intervention Type: DEVICE

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

Interventions

Primary PCI

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliero Universitaria Maggiore della Carita

OTHER

Sponsor Role: lead

Responsible Party

Lupi Alessandro

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alessandro Lupi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliero Universitaria Maggiore della Carita

Locations

Azienda Ospedaliero Universitaria Maggiore della Carita

Novara, Piedmont, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

ALESSANDRO LUPI, M.D.

Role: CONTACT

lupialessandro1@tin.it

+393495643838

Facility Contacts

Alessandro Lupi, M.D.

Role: primary

lupialessandro1@tin.it

+393495643838

References

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.

Reference Type: DERIVED

PMID: 29618159 (View on PubMed)

Other Identifiers

RENOVAMI01

Identifier Type: -

Identifier Source: org_study_id