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Completed

NCT Number: NCT02325973

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ospedale Giovanni Paolo II, Sciacca, Agrigento, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

PressureWire Certus guidewire

Device

Assessment of IMR index in coronaries through PressureWire Certus guidewire

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.

    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.

Secondary outcomes

  1. New Congestive Heart Failure (CHF) During Index Hospitalization

    Time frame: At the end of hospital stay

    Count of participants with a new CHF during index hospitalization. Hospital stay expected average = 5-10 days

  2. Left Ventricular (LV) Remodeling

    Time frame: 1 year

    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.

  3. Left Ventricular (LV) Remodeling

    Time frame: 1 year

    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.

  4. Left Ventricular (LV) Remodeling

    Time frame: 1 year

    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.

  5. Left Ventricular (LV) Remodeling

    Time frame: 1 year

    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

  6. Left Ventricular (LV) Remodeling - Mitral Insufficiency

    Time frame: 1 year

    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

  7. Need for New Revascularization

    Time frame: 1 year

    Incidence of new revascularizations at 1 year

  8. Stent Thrombosis

    Time frame: 1 year

    Incidence of stent thrombosis at 1 year

  9. Evaluation of a Better Cut-off of IMR Index Based on Primary Endpoints Events

    Time frame: 1 year

    Evaluation of a better cut-off of IMR index based on primary endpoints events. Table below reports the values of ROC curve.

  10. Evaluation of Possible Events Predictors

    Time frame: 1 year

    Results of logistic regression model; differences were considered statistically significant when p<0,05.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

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

Acronym: AMICRO

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Dec 25, 2014
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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