N/A
N=242
Assessing Microvascular Resistance Via IMR To Predict Cumulative Outcome in STEMI Patients Undergoing Primary PCI
Multi Vessel Coronary Artery Disease · STEMI
Bottom Line
View on ClinicalTrials.gov: NCT02325973 ↗Enrolled (actual)
242
Serious AEs
24.0%
Results posted
Aug 2025
Primary outcome: Primary: Composite of: Cardiovascular Death*, Re-myocardial Infarct, Re-hospitalization for Heart Failure (HF) and Congestive Heart Failure (CHF), Resuscitation or ICD Appropriate Shock. — 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PressureWire Certus guidewire (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite of: Cardiovascular Death*, Re-myocardial Infarct, Re-hospitalization for Heart Failure (HF) and Congestive Heart Failure (CHF), Resuscitation or ICD Appropriate Shock. |
8 | — |
| SECONDARY New Congestive Heart Failure (CHF) During Index Hospitalization |
8 | — |
| SECONDARY Left Ventricular (LV) Remodeling |
1.8; 1.9 | — |
| SECONDARY Left Ventricular (LV) Remodeling |
1.8; 1.9 | — |
| SECONDARY Left Ventricular (LV) Remodeling |
1.8; 1.9 | — |
| SECONDARY Left Ventricular (LV) Remodeling |
1.8; 1.9 | — |
| SECONDARY Left Ventricular (LV) Remodeling - Mitral Insufficiency |
35; 33; 130; 139; 29; 26 | — |
| SECONDARY Need for New Revascularization |
12 | — |
| SECONDARY Stent Thrombosis |
1 | — |
| SECONDARY Evaluation of a Better Cut-off of IMR Index Based on Primary Endpoints Events |
0.125; 0.114; 0.505; 0.375; 0.211; 0.582 | — |
| SECONDARY Evaluation of Possible Events Predictors |
0,3139; 0,8407; 0,0415; 0,3039; 0,1948; 0,5603 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02325973). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.