Assessing Microvascular Resistance Via IMR To Predict Cumulative Outcome in STEMI Patients Undergoing Primary PCI

NCT ID: NCT02325973

Last Updated: 2025-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 242 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2018-02-28

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.

Conditions

Multi Vessel Coronary Artery Disease; STEMI

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

IMR evaluation

Assessment of IMR index in coronaries through PressureWire Certus guidewire

Group Type: OTHER

PressureWire Certus guidewire

Intervention Type: DEVICE

Assessment of IMR index in coronaries through PressureWire Certus guidewire

Interventions

PressureWire Certus guidewire

Assessment of IMR index in coronaries through PressureWire Certus guidewire

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Massimo Fineschi, MD

Role: STUDY_CHAIR

Policlinico Le Scotte, Siena

Marco Valgimigli, MD

Role: STUDY_CHAIR

Locations

Ospedale Giovanni Paolo II

Sciacca, Agrigento, Italy

Ospedale Generale Regionale "F. Miulli"

Acquaviva delle Fonti, BA, Italy

Azienda Ospedaliera Universitaria Careggi

Florence, FI, Italy

Azienda Ospedaliera Villa Scassi

Genova, GE, Italy

Fondazione Toscana G.Monasterio - Ospedale del Cuore

Massa, MS, Italy

Azienda Ospedaliera di Padova

Padua, PD, Italy

Azienda Ospedaliera Ospedali Riuniti Marche Nord

Pesaro, PU, Italy

Fondazione IRCCS Policlinico S.Matteo

Pavia, PV, Italy

Arcispedale Santa Maria Nuova

Reggio Emilia, RE, Italy

Ospedale di Castelfranco Veneto

Castelfranco Veneto, Treviso, Italy

Presidio Ospedaliero di Conegliano

Conegliano, Treviso, Italy

Ospedale di Circolo Fondazione Macchi

Varese, VA, Italy

Ospedale Sant'Andrea

La Spezia, , Italy

Policlinico Le Scotte

Siena, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 36531736 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CV-12-018-IT-PW

Identifier Type: -

Identifier Source: org_study_id