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

STEMI Clinical Trial

— AMICRO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02325973
• Other study ID #: CV-12-018-IT-PW
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Est. completion date: February 2018

Study information

• Verified date: July 2020
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Multi Vessel Coronary Artery Disease
• ST Elevation Myocardial Infarction
• STEMI

Intervention

Device:
• PressureWire Certus guidewire
Assessment of IMR index in coronaries through PressureWire Certus guidewire

Locations

Country	Name	City	State
Italy	Ospedale Generale Regionale "F. Miulli"	Acquaviva delle Fonti	BA
Italy	Ospedale di Castelfranco Veneto	Castelfranco Veneto	Treviso
Italy	Presidio Ospedaliero di Conegliano	Conegliano	Treviso
Italy	Azienda Ospedaliera Universitaria Careggi	Firenze	FI
Italy	Azienda Ospedaliera Villa Scassi	Genova	GE
Italy	Ospedale Sant'Andrea	La Spezia
Italy	Fondazione Toscana G.Monasterio - Ospedale del Cuore	Massa	MS
Italy	Azienda Ospedaliera di Padova	Padova	PD
Italy	Fondazione IRCCS Policlinico S.Matteo	Pavia	PV
Italy	Azienda Ospedaliera Ospedali Riuniti Marche Nord	Pesaro	PU
Italy	Arcispedale Santa Maria Nuova	Reggio Emilia	RE
Italy	Ospedale Giovanni Paolo II	Sciacca	Agrigento
Italy	Policlinico Le Scotte	Siena
Italy	Ospedale di Circolo Fondazione Macchi	Varese	VA

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	New CHF during index hospitalization		At the end of hospital stay, an expected average of 5-10 days
Secondary	Left Ventricular (LV) remodeling		1 year
Secondary	Need for new revascularization (revascularization yes/no)		1 year
Secondary	Stent thrombosis (thrombosis yes/no)		1 year
Secondary	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