NCT02325973

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
242

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

14 active sites

Status
completed

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

June 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2014

Completed
11 months until next milestone

First Posted

Study publicly available on registry

December 25, 2014

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
7.5 years until next milestone

Results Posted

Study results publicly available

August 8, 2025

Completed
Last Updated

August 8, 2025

Status Verified

July 1, 2025

Enrollment Period

4.7 years

First QC Date

January 30, 2014

Results QC Date

February 2, 2024

Last Update Submit

July 23, 2025

Conditions

Multi Vessel Coronary Artery DiseaseSTEMI

Keywords

STEMIIMRFFRmicrocirculatory

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year

Secondary Outcomes (10)

  • New Congestive Heart Failure (CHF) During Index Hospitalization

    At the end of hospital stay

  • Left Ventricular (LV) Remodeling

    1 year

  • Left Ventricular (LV) Remodeling

    1 year

  • Left Ventricular (LV) Remodeling

    1 year

  • Left Ventricular (LV) Remodeling

    1 year

  • +5 more secondary outcomes

Study Arms (1)

IMR evaluation

OTHER

Assessment of IMR index in coronaries through PressureWire Certus guidewire

Device: PressureWire Certus guidewire

Interventions

PressureWire Certus guidewireDEVICE

Assessment of IMR index in coronaries through PressureWire Certus guidewire

IMR evaluation

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Ospedale Giovanni Paolo II

Sciacca, Agrigento, 92019, Italy

Location

Ospedale Generale Regionale "F. Miulli"

Acquaviva delle Fonti, BA, 70021, Italy

Location

Azienda Ospedaliera Universitaria Careggi

Florence, FI, 50134, Italy

Location

Azienda Ospedaliera Villa Scassi

Genova, GE, 16149, Italy

Location

Fondazione Toscana G.Monasterio - Ospedale del Cuore

Massa, MS, 54100, Italy

Location

Azienda Ospedaliera di Padova

Padua, PD, 35128, Italy

Location

Azienda Ospedaliera Ospedali Riuniti Marche Nord

Pesaro, PU, 61121, Italy

Location

Fondazione IRCCS Policlinico S.Matteo

Pavia, PV, 27100, Italy

Location

Arcispedale Santa Maria Nuova

Reggio Emilia, RE, 43123, Italy

Location

Ospedale di Castelfranco Veneto

Castelfranco Veneto, Treviso, 31033, Italy

Location

Presidio Ospedaliero di Conegliano

Conegliano, Treviso, 31015, Italy

Location

Ospedale di Circolo Fondazione Macchi

Varese, VA, 21100, Italy

Location

Ospedale Sant'Andrea

La Spezia, 19100, Italy

Location

Policlinico Le Scotte

Siena, 53100, Italy

Location

Related Publications (1)

  • 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.

    PMID: 36531736DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Vanoni Benedetta, Abbott Clinical Site Lead
Organization
Abbott Medical Italia
benedetta.vanoni@abbott.com
+39340571064

Study Officials

  • Massimo Fineschi, MD

    Policlinico Le Scotte, Siena

    STUDY CHAIR

  • Marco Valgimigli, MD

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2014

First Posted

December 25, 2014

Study Start

June 1, 2013

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

August 8, 2025

Results First Posted

August 8, 2025

Record last verified: 2025-07

Locations

IT(14)