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

Primary Purpose

Multi Vessel Coronary Artery Disease, STEMI

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
PressureWire Certus guidewire
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Multi Vessel Coronary Artery Disease focused on measuring STEMI, IMR, FFR, microcirculatory

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ospedale Giovanni Paolo II
  • Ospedale Generale Regionale "F. Miulli"
  • Azienda Ospedaliera Universitaria Careggi
  • Azienda Ospedaliera Villa Scassi
  • Fondazione Toscana G.Monasterio - Ospedale del Cuore
  • Azienda Ospedaliera di Padova
  • Azienda Ospedaliera Ospedali Riuniti Marche Nord
  • Fondazione IRCCS Policlinico S.Matteo
  • Arcispedale Santa Maria Nuova
  • Ospedale di Castelfranco Veneto
  • Presidio Ospedaliero di Conegliano
  • Ospedale di Circolo Fondazione Macchi
  • Ospedale Sant'Andrea
  • Policlinico Le Scotte

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

IMR evaluation

Arm Description

Assessment of IMR index in coronaries through PressureWire Certus guidewire

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

New CHF during index hospitalization
Left Ventricular (LV) remodeling
Need for new revascularization (revascularization yes/no)
Stent thrombosis (thrombosis yes/no)
ST resolution or residual ST elevation post PCI (Electrocardiographic ST-segment elevation in two or more contiguous electrocardiogram (ECG) leads)

Full Information

First Posted
January 30, 2014
Last Updated
July 23, 2020
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT02325973
Brief Title
Assessing Microvascular Resistance Via IMR To Predict Cumulative Outcome in STEMI Patients Undergoing Primary PCI
Acronym
AMICRO
Official Title
Assessing Microvascular Resistance Via IMR To Predict Cumulative Outcome in STEMI Patients Undergoing Primary PCI (AMICRO)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multi Vessel Coronary Artery Disease, STEMI
Keywords
STEMI, IMR, FFR, microcirculatory

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
242 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IMR evaluation
Arm Type
Other
Arm Description
Assessment of IMR index in coronaries through PressureWire Certus guidewire
Intervention Type
Device
Intervention Name(s)
PressureWire Certus guidewire
Intervention Description
Assessment of IMR index in coronaries through PressureWire Certus guidewire
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
New CHF during index hospitalization
Time Frame
At the end of hospital stay, an expected average of 5-10 days
Title
Left Ventricular (LV) remodeling
Time Frame
1 year
Title
Need for new revascularization (revascularization yes/no)
Time Frame
1 year
Title
Stent thrombosis (thrombosis yes/no)
Time Frame
1 year
Title
ST resolution or residual ST elevation post PCI (Electrocardiographic ST-segment elevation in two or more contiguous electrocardiogram (ECG) leads)
Time Frame
At the end of hospital stay, an expected average of 5-10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Massimo Fineschi, MD
Organizational Affiliation
Policlinico Le Scotte, Siena
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Marco Valgimigli, MD
Official's Role
Study Chair
Facility Information:
Facility Name
Ospedale Giovanni Paolo II
City
Sciacca
State/Province
Agrigento
ZIP/Postal Code
92019
Country
Italy
Facility Name
Ospedale Generale Regionale "F. Miulli"
City
Acquaviva delle Fonti
State/Province
BA
ZIP/Postal Code
70021
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Careggi
City
Firenze
State/Province
FI
ZIP/Postal Code
50134
Country
Italy
Facility Name
Azienda Ospedaliera Villa Scassi
City
Genova
State/Province
GE
ZIP/Postal Code
16149
Country
Italy
Facility Name
Fondazione Toscana G.Monasterio - Ospedale del Cuore
City
Massa
State/Province
MS
ZIP/Postal Code
54100
Country
Italy
Facility Name
Azienda Ospedaliera di Padova
City
Padova
State/Province
PD
ZIP/Postal Code
35128
Country
Italy
Facility Name
Azienda Ospedaliera Ospedali Riuniti Marche Nord
City
Pesaro
State/Province
PU
ZIP/Postal Code
61121
Country
Italy
Facility Name
Fondazione IRCCS Policlinico S.Matteo
City
Pavia
State/Province
PV
ZIP/Postal Code
27100
Country
Italy
Facility Name
Arcispedale Santa Maria Nuova
City
Reggio Emilia
State/Province
RE
ZIP/Postal Code
43123
Country
Italy
Facility Name
Ospedale di Castelfranco Veneto
City
Castelfranco Veneto
State/Province
Treviso
ZIP/Postal Code
31033
Country
Italy
Facility Name
Presidio Ospedaliero di Conegliano
City
Conegliano
State/Province
Treviso
ZIP/Postal Code
31015
Country
Italy
Facility Name
Ospedale di Circolo Fondazione Macchi
City
Varese
State/Province
VA
ZIP/Postal Code
21100
Country
Italy
Facility Name
Ospedale Sant'Andrea
City
La Spezia
ZIP/Postal Code
19100
Country
Italy
Facility Name
Policlinico Le Scotte
City
Siena
ZIP/Postal Code
53100
Country
Italy

12. IPD Sharing Statement

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

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