Clinical trial NCT02325973: Assessing Microvascular Resistance Via IMR To Predict Cumulative Outcome in STEMI Patients Undergoing Primary PCI
Official title: Assessing Microvascular Resistance Via IMR To Predict Cumulative Outcome in STEMI Patients Undergoing Primary PCI (AMICRO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multi Vessel Coronary Artery Disease
STEMI
Keywords: STEMI
IMR
FFR
microcirculatory
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2014-12-25
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Patient of legal age in hosting country able and willing to provide informed consent form
2. Hospital admission either within 12 h of symptom onset or between 12 and 24 h after onset with evidence of continuing ischemia
3. Electrocardiographic ST-segment elevation ≥1 mm in two or more contiguous ECG leads, or with a left bundle-branch block (LBBB)
4. Multivessel diseased patients with lesions in the proximal 2/3 part of the vessels
5. Culprit Lesion EyeBall (EB) identified during evaluation of basal angiography
6. 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

Exclusion Criteria:

1. Patients who cannot give informed consent
2. A life expectancy of less than 1 year
3. Patients who are pregnant or nursing
4. Contra-indication to angiography
5. Allergy/intolerance to Adenosine
6. Contra-indication/Allergy/Intolerance to contrast media or to medical therapy foreseen for PCI
7. Documented allergy to Adenosine diphosphate (ADP) inhibitors (aspirin and clopidogrel)
8. New infarct on the same area of a previous infarct
9. Critical non treatable Lesion EB\>70% downstream of the culprit lesion
10. Absence of non-culprit lesion/s
11. Patient with hemodynamic instability not controllable with medical therapy and/or need intra aortic balloon pump implantation (IABP)
12. Prior Coronary Artery Bypass Graft (CABG) or indication for CABG
13. Patients with Left Main (LM) coronary artery disease requiring revascularization

Primary outcomes:
measure: Composite of: cardiovascular death*, re-myocardial infarct, re-hospitalization for heart failure (HF) and Congestive Heart Failure (CHF), resuscitation or ICD appropriate shock.
timeFrame: 1 year
Secondary outcomes:
measure: New CHF during index hospitalization
timeFrame: At the end of hospital stay, an expected average of 5-10 days
measure: Left Ventricular (LV) remodeling
timeFrame: 1 year
measure: Need for new revascularization (revascularization yes/no)
timeFrame: 1 year
measure: Stent thrombosis (thrombosis yes/no)
timeFrame: 1 year
measure: ST resolution or residual ST elevation post PCI (Electrocardiographic ST-segment elevation in two or more contiguous electrocardiogram (ECG) leads)
timeFrame: At the end of hospital stay, an expected average of 5-10 days
Other outcomes:
Locations:
city: Sciacca
country: Italy
facility: Ospedale Giovanni Paolo II
state: Agrigento
city: Acquaviva delle Fonti
country: Italy
facility: Ospedale Generale Regionale "F. Miulli"
state: BA
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
state: FI
city: Genova
country: Italy
facility: Azienda Ospedaliera Villa Scassi
state: GE
city: Massa
country: Italy
facility: Fondazione Toscana G.Monasterio - Ospedale del Cuore
state: MS
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
state: PD
city: Pesaro
country: Italy
facility: Azienda Ospedaliera Ospedali Riuniti Marche Nord
state: PU
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico S.Matteo
state: PV
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova
state: RE
city: Castelfranco Veneto
country: Italy
facility: Ospedale di Castelfranco Veneto
state: Treviso
city: Conegliano
country: Italy
facility: Presidio Ospedaliero di Conegliano
state: Treviso
city: Varese
country: Italy
facility: Ospedale di Circolo Fondazione Macchi
state: VA
city: La Spezia
country: Italy
facility: Ospedale Sant'Andrea
city: Siena
country: Italy
facility: Policlinico Le Scotte
Study officials:
affiliation: Policlinico Le Scotte, Siena
name: Massimo Fineschi, MD
role: STUDY_CHAIR
name: Marco Valgimigli, MD
role: STUDY_CHAIR
References: