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

Acute Myocardial Infarction Clinical Trial

— RENOVAMI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01760382
• Other study ID #: RENOVAMI01
• Status: Recruiting
• Phase: N/A
• First received: December 30, 2012
• Last updated: March 25, 2015
• Start date: January 2011
• Est. completion date: March 2016

Study information

• Verified date: March 2015
• Source: Azienda Ospedaliero Universitaria Maggiore della Carita
• Contact: ALESSANDRO LUPI, M.D.
• Phone: +393495643838
• Email: lupialessandro1[@]tin.it
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: March 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Device:
• Primary PCI
mechanical reopening of the STEMI-related coronary artery by PTCA, with or without coronary stent implantation

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero Universitaria Maggiore della Carita	Novara	Piedmont

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero Universitaria Maggiore della Carita

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful reperfusion	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).	1 day	No
Secondary	In Hospital Cardiac Mortality	In Hospital death for cardiac causes	1 week	No
Secondary	In hospital myocardial infarction	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	1 week	No
Secondary	In hospital stent thrombosis	In hospital thrombosis of the stent implanted in the STEMI-related artery	1 week	No