NCT01760382

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 30, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 4, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 26, 2015

Status Verified

March 1, 2015

Enrollment Period

4.9 years

First QC Date

December 30, 2012

Last Update Submit

March 25, 2015

Conditions

Acute Myocardial Infarction

Keywords

Acute myocardial infarctionST elevation myocardial infarctionprimary PCIreperfusion therapyangioplastystent

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • In Hospital Cardiac Mortality

    1 week

  • In hospital myocardial infarction

    1 week

  • In hospital stent thrombosis

    1 week

Study Arms (2)

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

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

Interventions

Primary PCIDEVICE

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

STEMI Hospital ED Primary PCI patientsSTEMI network Primary PCI patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • symptoms beginning more than 12 hours before (with patient asymptomatic)
  • survival estimated \< 6 months according to the treating physician

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliero Universitaria Maggiore della Carita

Novara, Piedmont, 28100, Italy

RECRUITING

Related Publications (1)

  • 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.

    PMID: 29618159DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Alessandro Lupi, M.D.

    Azienda Ospedaliero Universitaria Maggiore della Carita

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ALESSANDRO LUPI, M.D.

CONTACT

+393495643838lupialessandro1@tin.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 30, 2012

First Posted

January 4, 2013

Study Start

January 1, 2011

Primary Completion

December 1, 2015

Study Completion

March 1, 2016

Last Updated

March 26, 2015

Record last verified: 2015-03

Locations

IT(1)