REgister of Myocardial Infarction Patients Treated by the NOVAra STE-MI Network (RENOVAMI)
Recruitment status was Recruiting
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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 |
- 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).
- 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 |
Patients with chest pain or equivalents (dyspnea, epigastrial pain) and ST segmnent elevation on more 2 or more contiguous ECG leads
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01760382
| Contact: ALESSANDRO LUPI, M.D. | +393495643838 | lupialessandro1@tin.it |
| Italy | |
| Azienda Ospedaliero Universitaria Maggiore della Carita | Recruiting |
| Novara, Piedmont, Italy, 28100 | |
| Contact: Alessandro Lupi, M.D. +393495643838 lupialessandro1@tin.it | |
| 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 Cardiovascular Diseases Heart Diseases Ischemia |
Myocardial Ischemia Necrosis Pathologic Processes Vascular Diseases |
ClinicalTrials.gov processed this record on March 03, 2015