Multi Vessel Coronary Artery DiseaseAMICRONCT02325973
Assessing Microvascular Resistance Via IMR To Predict Cumulative Outcome in STEMI Patients Undergoing Primary PCI
A study testing PressureWire Certus guidewire in people with Multi Vessel Coronary Artery Disease and STEMI, run by Abbott Medical Devices at 14 sites in Italy.
Trial summary
The purpose of this study is to assess whether the Index of Microcirculatory Resistance (IMR) can be considered a prognostic predictor for the occurrence of events at one year of follow up after primary Percutaneous Coronary Intervention (PCI) in ST-Elevation Myocardial Infarction (STEMI) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multi Vessel Coronary Artery Disease, STEMI
- What is being tested?
- PressureWire Certus guidewire
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 14 sitesItaly
- Study dates
- Jun 2013to Feb 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Patient of legal age in hosting country able and willing to provide informed consent form
- Hospital admission either within 12 h of symptom onset or between 12 and 24 h after onset with evidence of continuing ischemia
- Electrocardiographic ST-segment elevation ≥1 mm in two or more contiguous ECG leads, or with a left bundle-branch block (LBBB)
- Multivessel diseased patients with lesions in the proximal 2/3 part of the vessels
- Culprit Lesion EyeBall (EB) identified during evaluation of basal angiography
- Presence of at least one non-culprit lesion >50% EB detected in the basal angiography and eligible for PCI for which the operators decision is to perform a staged pre-discharge angioplasty procedure
Who cannot join
- Patients who cannot give informed consent
- A life expectancy of less than 1 year
- Patients who are pregnant or nursing
- Contra-indication to angiography
- Allergy/intolerance to Adenosine
- Contra-indication/Allergy/Intolerance to contrast media or to medical therapy foreseen for PCI
Show all 13Show fewer
- Documented allergy to Adenosine diphosphate (ADP) inhibitors (aspirin and clopidogrel)
- New infarct on the same area of a previous infarct
- Critical non treatable Lesion EB>70% downstream of the culprit lesion
- Absence of non-culprit lesion/s
- Patient with hemodynamic instability not controllable with medical therapy and/or need intra aortic balloon pump implantation (IABP)
- Prior Coronary Artery Bypass Graft (CABG) or indication for CABG
- Patients with Left Main (LM) coronary artery disease requiring revascularization
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Italy14 sites
Ospedale Generale Regionale "F. Miulli"
Acquaviva delle Fonti, BA, 70021
Ospedale di Castelfranco Veneto
Castelfranco Veneto, Treviso, 31033
Presidio Ospedaliero di Conegliano
Conegliano, Treviso, 31015
Azienda Ospedaliera Universitaria Careggi
Florence, FI, 50134
Azienda Ospedaliera Villa Scassi
Genova, GE, 16149
Ospedale Sant'Andrea
La Spezia, 19100
Fondazione Toscana G.Monasterio - Ospedale del Cuore
Massa, MS, 54100
Azienda Ospedaliera di Padova
Padova, PD, 35128
Fondazione IRCCS Policlinico S.Matteo
Pavia, PV, 27100
Azienda Ospedaliera Ospedali Riuniti Marche Nord
Pesaro, PU, 61121
Arcispedale Santa Maria Nuova
Reggio Emilia, RE, 43123
Ospedale Giovanni Paolo II
Sciacca, Agrigento, 92019
Policlinico Le Scotte
Siena, 53100
Ospedale di Circolo Fondazione Macchi
Varese, VA, 21100
About this study
Official title: Assessing Microvascular Resistance Via IMR To Predict Cumulative Outcome in STEMI Patients Undergoing Primary PCI (AMICRO)
The purpose of this study is to assess whether the Index of Microcirculatory Resistance (IMR) can be considered a prognostic predictor for the occurrence of events at one year of follow up after primary Percutaneous Coronary Intervention (PCI) in ST-Elevation Myocardial Infarction (STEMI) patients.
Any correlation between IMR and the short and medium term outcomes, defined as cardiovascular death, re-Myocardial Infarct (MI), re-hospitalization for Heart Failure (HF), resuscitation or Implantable Cardioverter Defibrillator (ICD) appropriate shock, will be assessed in the study.
Read the detailed description
Prospective, multicentre study designed to evaluate IMR ability to predict events occurrence, defined as Cardiovascular death, re-MI, re-hospitalization for HF, resuscitation or ICD appropriate shock, during a 1 year follow-up period.
All participants will have the culprit lesion treated following clinical practice and guidelines; Fractional Flow Reserve (FFR) and IMR will be measured after the primary PCI procedure to evaluate treatment success and myocardial viability. Non-culprit lesions will be functionally evaluated through FFR index and will be treated if FFR will show functional stenosis. FFR and IMR will be measured to evaluate treatment success and myocardial viability. Patients will be followed-up at 1m, 6m and 1y periods.
- Conditions
- Multi Vessel Coronary Artery Disease, STEMI
- Being tested
- PressureWire Certus guidewire
- Keywords
- STEMI, IMR, FFR, microcirculatory
- 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.
PressureWire Certus guidewireDevice
Assessment of IMR index in coronaries through PressureWire Certus guidewire
| Study group | Role | What they receive |
|---|---|---|
| IMR evaluation | Other | Assessment of IMR index in coronaries through PressureWire Certus guidewire Receives: Device: PressureWire Certus guidewire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of: Cardiovascular Death*, Re-myocardial Infarct, Re-hospitalization for Heart Failure (HF) and Congestive Heart Failure (CHF), Resuscitation or ICD Appropriate Shock.
Composite of: cardiovascular death*, re-myocardial infarct, re-hospitalization for heart failure (HF) and Congestive Heart Failure (CHF), resuscitation or ICD appropriate shocK, at 1 year.
- = timing of mortality evaluation: once culprit lesion has been evaluated through IMR
Composite endpoint was evaluated as time to first event, whichever individual component occurred first.
Measured: 1 year
Secondary outcomes (10)
New Congestive Heart Failure (CHF) During Index Hospitalization
Count of participants with a new CHF during index hospitalization. Hospital stay expected average = 5-10 days
Measured: At the end of hospital stay
Left Ventricular (LV) Remodeling
Left Ventricular (LV) remodeling at 1 year; improvement of Ejection Fraction %(EF) assessed by TTE.
A TTE evaluation has been done both at discharge and at 1-year fup.
Measured: 1 year
Left Ventricular (LV) Remodeling
Left Ventricular (LV) remodeling at 1 year; improvement of Left Ventricular End Systole Volume (LVESV) and Left Ventricular End Diastole Volume (LVEDV) assessed by TTE.
A TTE evaluation has been done both at discharge and at 1-year fup.
Measured: 1 year
Left Ventricular (LV) Remodeling
Left Ventricular (LV) remodeling at 1 year; improvement of Left Ventricular End Diastole Diameter (LVEDD) and Left Ventricular End Systole Diameter (LVESD) assessed by TTE.
A TTE evaluation has been done both at discharge and at 1-year fup.
Measured: 1 year
Left Ventricular (LV) Remodeling
Left Ventricular (LV) remodeling at 1 year; improvement of 16 segments Wall Motion Score Index (WMSI) assessed by TTE.
A TTE evaluation has been done both at discharge and at 1-year fup. 16WMSI = 1 is considered normokinetic; 16WMSI = 1,5 is considered mild hypokinesia; 16WMSI = 2 is considered hypokinesia; 16WMSI = 2,5 is considered severe hypokinesia; 16WMSI = 3 is considered akinetic.
Scale range: from 1 to 3
Measured: 1 year
Left Ventricular (LV) Remodeling - Mitral Insufficiency
Left Ventricular (LV) remodeling at 1 year; improvement of mitral insufficiency (MI) values assessed by TTE.
A TTE evalutation has been done both at discharge and at 1-year fup. Each row reports the number of participants that have that specific grade of mitral insufficiency.
Grade = 0 indicates no MI; grade = 1 indicates mild MI; grade = 2 indicates moderate MI; grade = 3 indicates severe MI
Measured: 1 year
Need for New Revascularization
Incidence of new revascularizations at 1 year
Measured: 1 year
Stent Thrombosis
Incidence of stent thrombosis at 1 year
Measured: 1 year
Evaluation of a Better Cut-off of IMR Index Based on Primary Endpoints Events
Evaluation of a better cut-off of IMR index based on primary endpoints events. Table below reports the values of ROC curve.
Measured: 1 year
Evaluation of Possible Events Predictors
Results of logistic regression model; differences were considered statistically significant when p<0,05.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2014 (estimated)
- Study startJun 2013
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multi Vessel Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Massimo Fineschi, MD, Study chair, Policlinico Le Scotte, SienaMarco Valgimigli, MD, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02325973
- Sponsor's protocol ID
- CV-12-018-IT-PW
- Acronym
- AMICRO
- Status last verified
- Jul 2025
- First submitted
- 30 Jan 2014
- Last updated
- 8 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Fineschi M, Verna E, Barioli A, Mezzapelle G, Bartolini D, Turiano G, Guiducci V, Manari A, Lucarelli K, Uguccioni L, Repetto A, Tarantini G. One-year results from the Assessing MICRO-vascular resistances via IMR to predict outcome in ST-elevation myocardial infarction patients with multivessel disease undergoing primary PCI (AMICRO) trial. Front Cardiovasc Med. 2022 Dec 2;9:1051174. doi: 10.3389/fcvm.2022.1051174. eCollection 2022.
PubMed 36531736
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Microvascular Resistance Via IMR To Predict Cumulative Outcome in STEMI Patients Undergoing Primary PCI (AMICRO)
- ClinicalTrials.gov ID
- NCT02325973
- Acronym / sponsor ID
- AMICRO / CV-12-018-IT-PW
- Conditions
- Multi Vessel Coronary Artery Disease, STEMI
- Keywords
- STEMI, IMR, FFR, microcirculatory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 25 Dec 2014 (estimated)
- Results
- Posted 8 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess whether the Index of Microcirculatory Resistance (IMR) can be considered a prognostic predictor for the occurrence of events at one year of follow up after primary Percutaneous Coronary Intervention (PCI) in ST-Elevation Myocardial Infarction (STEMI) patients.
Any correlation between IMR and the short and medium term outcomes, defined as cardiovascular death, re-Myocardial Infarct (MI), re-hospitalization for Heart Failure (HF), resuscitation or Implantable Cardioverter Defibrillator (ICD) appropriate shock, will be assessed in the study.
Detailed description
Prospective, multicentre study designed to evaluate IMR ability to predict events occurrence, defined as Cardiovascular death, re-MI, re-hospitalization for HF, resuscitation or ICD appropriate shock, during a 1 year follow-up period.
All participants will have the culprit lesion treated following clinical practice and guidelines; Fractional Flow Reserve (FFR) and IMR will be measured after the primary PCI procedure to evaluate treatment success and myocardial viability. Non-culprit lesions will be functionally evaluated through FFR index and will be treated if FFR will show functional stenosis. FFR and IMR will be measured to evaluate treatment success and myocardial viability. Patients will be followed-up at 1m, 6m and 1y periods.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMR evaluation | Other | Device: PressureWire Certus guidewireAssessment of IMR index in coronaries through PressureWire Certus guidewire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient of legal age in hosting country able and willing to provide informed consent form
- Hospital admission either within 12 h of symptom onset or between 12 and 24 h after onset with evidence of continuing ischemia
- Electrocardiographic ST-segment elevation ≥1 mm in two or more contiguous ECG leads, or with a left bundle-branch block (LBBB)
- Multivessel diseased patients with lesions in the proximal 2/3 part of the vessels
- Culprit Lesion EyeBall (EB) identified during evaluation of basal angiography
Key exclusion criteria (13 listed)
- Patients who cannot give informed consent
- A life expectancy of less than 1 year
- Patients who are pregnant or nursing
- Contra-indication to angiography
- Allergy/intolerance to Adenosine
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 |
|---|---|---|
| PressureWire Certus guidewireAssessment of IMR index in coronaries through PressureWire Certus guidewire | Device | IMR evaluation |
Primary outcome
Composite of: Cardiovascular Death*, Re-myocardial Infarct, Re-hospitalization for Heart Failure (HF) and Congestive Heart Failure (CHF), Resuscitation or ICD Appropriate Shock.
Time frame: 1 year
Composite of: cardiovascular death*, re-myocardial infarct, re-hospitalization for heart failure (HF) and Congestive Heart Failure (CHF), resuscitation or ICD appropriate shocK, at 1 year. * = timing of mortality evaluation: once culprit lesion has been evaluated through IMR Composite endpoint was evaluated as time to first event, whichever individual component occurred first.
10 secondary outcomes
New Congestive Heart Failure (CHF) During Index Hospitalization
Time frame: At the end of hospital stay
Left Ventricular (LV) Remodeling
Time frame: 1 year
Left Ventricular (LV) Remodeling
Time frame: 1 year
Left Ventricular (LV) Remodeling
Time frame: 1 year
Left Ventricular (LV) Remodeling
Time frame: 1 year
Left Ventricular (LV) Remodeling - Mitral Insufficiency
Time frame: 1 year
Need for New Revascularization
Time frame: 1 year
Stent Thrombosis
Time frame: 1 year
Evaluation of a Better Cut-off of IMR Index Based on Primary Endpoints Events
Time frame: 1 year
Evaluation of Possible Events Predictors
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36531736Fineschi M, Verna E, Barioli A, Mezzapelle G, Bartolini D, Turiano G, Guiducci V, Manari A, Lucarelli K, Uguccioni L, Repetto A, Tarantini G. One-year results from the Assessing MICRO-vascular resistances via IMR to predict outcome in ST-elevation myocardial infarction patients with multivessel disease undergoing primary PCI (AMICRO) trial. Front Cardiovasc Med. 2022 Dec 2;9:1051174. doi: 10.3389/fcvm.2022.1051174. eCollection 2022.
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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.
Massimo Fineschi, MD study chair
Policlinico Le Scotte, Siena
Marco Valgimigli, MD study chair
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PressureWire Certus guidewire in people with Multi Vessel Coronary Artery Disease and STEMI, run by Abbott Medical Devices at 14 sites 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 6 inclusion and 13 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: finished, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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?
Yes. Results are posted in the registry (first posted 8 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of: Cardiovascular Death*, Re-myocardial Infarct, Re-hospitalization for Heart Failure (HF) and Congestive Heart Failure (CHF), Resuscitation or ICD Appropriate Shock. (time frame: 1 year). 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 NCT02325973, 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 8 Aug 2025.