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

Not Applicable

Completed

• Conditions: STEMI; Multi Vessel Coronary Artery Disease
• Interventions: Device: PressureWire Certus guidewire

• Registration Number: NCT02325973
• Lead Sponsor: Abbott Medical Devices

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.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2014-01-30
• Study First Submitted QC: 2014-12-19
• Study First Posted: 2014-12-25
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-23
• Last Update Posted: 2020-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 242

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IMR evaluation	PressureWire Certus guidewire	Assessment of IMR index in coronaries through PressureWire Certus guidewire

Primary Outcome Measures

Name	Time	Method
Composite of: cardiovascular death*, re-myocardial infarct, re-hospitalization for heart failure (HF) and Congestive Heart Failure (CHF), resuscitation or ICD appropriate shock.	1 year

Secondary Outcome Measures

Name	Time	Method
Left Ventricular (LV) remodeling	1 year
New CHF during index hospitalization	At the end of hospital stay, an expected average of 5-10 days
Need for new revascularization (revascularization yes/no)	1 year
Stent thrombosis (thrombosis yes/no)	1 year
ST resolution or residual ST elevation post PCI (Electrocardiographic ST-segment elevation in two or more contiguous electrocardiogram (ECG) leads)	At the end of hospital stay, an expected average of 5-10 days

Trial Locations

Locations (14)

Ospedale Giovanni Paolo II; 🇮🇹 Sciacca, Agrigento, Italy

Azienda Ospedaliera Universitaria Careggi; 🇮🇹 Firenze, FI, Italy

Azienda Ospedaliera di Padova; 🇮🇹 Padova, PD, Italy

Azienda Ospedaliera Villa Scassi; 🇮🇹 Genova, GE, Italy

Fondazione Toscana G.Monasterio - Ospedale del Cuore; 🇮🇹 Massa, MS, 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

Ospedale di Circolo Fondazione Macchi; 🇮🇹 Varese, VA, Italy

Ospedale Sant'Andrea; 🇮🇹 La Spezia, Italy

Policlinico Le Scotte; 🇮🇹 Siena, Italy

Ospedale Generale Regionale "F. Miulli"; 🇮🇹 Acquaviva delle Fonti, BA, Italy

Presidio Ospedaliero di Conegliano; 🇮🇹 Conegliano, Treviso, Italy