Acute Myocardial InfarctionRENOVAMINCT01760382
REgister of Myocardial Infarction Patients Treated by the NOVAra STE-MI Network
An observational study of Acute Myocardial Infarction, run by Azienda Ospedaliero Universitaria Maggiore della Carita at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Primary PCI
- Type of treatment
- Medical device
- How many people
- 700 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2011to Mar 2016
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chest pain or equivalents (dyspnea, epigastrial pain) and ST segmnent elevation on more 2 or more contiguous ECG leads
Who may be able to join
- 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
Who cannot join
- symptoms beginning more than 12 hours before (with patient asymptomatic)
- survival estimated < 6 months according to the treating physician
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliero Universitaria Maggiore della Carita
Novara, Piedmont, 28100
Alessandro Lupi, M.D., +393495643838, lupialessandro1@tin.it
About this study
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).
Read the 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
- Being tested
- Primary PCI
- Keywords
- Acute myocardial infarction, ST elevation myocardial infarction, primary PCI, reperfusion therapy, angioplasty, stent
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary PCIDevice
mechanical reopening of the STEMI-related coronary artery by PTCA, with or without coronary stent implantation
| Study group | Role | What they receive |
|---|---|---|
| STEMI network Primary PCI patients | Patients with STEMI brought to the Hub Hospital by the STEMI network ambulance and treated by primary PCI. Receives: 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 Receives: Device: Primary PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 day
Secondary outcomes (3)
In Hospital Cardiac Mortality
In Hospital death for cardiac causes
Measured: 1 week
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
Measured: 1 week
In hospital stent thrombosis
In hospital thrombosis of the stent implanted in the STEMI-related artery
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2013 (estimated)
- Study startJan 2011
- Primary completionDec 2015 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della Carita
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lupi Alessandro, Azienda Ospedaliero Universitaria Maggiore della Carita
- Investigators
- Alessandro Lupi, M.D., Principal investigator, Azienda Ospedaliero Universitaria Maggiore della Carita
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01760382
- Sponsor's protocol ID
- RENOVAMI01
- Acronym
- RENOVAMI
- Status last verified
- Mar 2015
- First submitted
- 30 Dec 2012
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29618159
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REgister of Myocardial Infarction Patients Treated by the NOVAra STE-MI Network
- ClinicalTrials.gov ID
- NCT01760382
- Acronym / sponsor ID
- RENOVAMI / RENOVAMI01
- Conditions
- Acute Myocardial Infarction
- Keywords
- Acute myocardial infarction, ST elevation myocardial infarction, primary PCI, reperfusion therapy, angioplasty, stent
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della CaritaUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 4 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STEMI network Primary PCI patients | – | Device: Primary PCIPatients with STEMI brought to the Hub Hospital by the STEMI network ambulance and treated by primary PCI. |
| STEMI Hospital ED Primary PCI patients | – | Device: Primary PCIPatients with STEMI who reached by themselves the Hub Hospital, where they were admitted for STEMI and tretated by Primary PCI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chest pain or equivalents (dyspnea, epigastrial pain) and ST segmnent elevation on more 2 or more contiguous ECG leads
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- symptoms beginning more than 12 hours before (with patient asymptomatic)
- survival estimated < 6 months according to the treating physician
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primary PCImechanical reopening of the STEMI-related coronary artery by PTCA, with or without coronary stent implantation | Device | STEMI Hospital ED Primary PCI patients, STEMI network Primary PCI patients |
Primary outcome
Successful reperfusion
Time frame: 1 day
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).
3 secondary outcomes
In Hospital Cardiac Mortality
Time frame: 1 week
In hospital myocardial infarction
Time frame: 1 week
In hospital stent thrombosis
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2015.
- Derived from this study: PubMed 29618159Lupi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alessandro Lupi, M.D. principal investigator
Azienda Ospedaliero Universitaria Maggiore della Carita
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction, run by Azienda Ospedaliero Universitaria Maggiore della Carita at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ALESSANDRO LUPI, M.D. (+393495643838, lupialessandro1@tin.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful reperfusion (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01760382, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2015.