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

Sponsor
Abbott Medical Devices (Industry)
Overall Status
Completed
CT.gov ID
NCT02325973
Collaborator
(none)
242
Enrollment
14
Locations
1
Arm
56
Duration (Months)
17.3
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: PressureWire Certus guidewire
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
242 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Assessing Microvascular Resistance Via IMR To Predict Cumulative Outcome in STEMI Patients Undergoing Primary PCI (AMICRO)
Study Start Date :
Jun 1, 2013
Actual Primary Completion Date :
Feb 1, 2018
Actual Study Completion Date :
Feb 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Other: IMR evaluation

Assessment of IMR index in coronaries through PressureWire Certus guidewire

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. New CHF during index hospitalization [At the end of hospital stay, an expected average of 5-10 days]

  2. Left Ventricular (LV) remodeling [1 year]

  3. Need for new revascularization (revascularization yes/no) [1 year]

  4. Stent thrombosis (thrombosis yes/no) [1 year]

  5. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ospedale Giovanni Paolo II Sciacca Agrigento Italy 92019
2 Ospedale Generale Regionale "F. Miulli" Acquaviva delle Fonti BA Italy 70021
3 Azienda Ospedaliera Universitaria Careggi Firenze FI Italy 50134
4 Azienda Ospedaliera Villa Scassi Genova GE Italy 16149
5 Fondazione Toscana G.Monasterio - Ospedale del Cuore Massa MS Italy 54100
6 Azienda Ospedaliera di Padova Padova PD Italy 35128
7 Azienda Ospedaliera Ospedali Riuniti Marche Nord Pesaro PU Italy 61121
8 Fondazione IRCCS Policlinico S.Matteo Pavia PV Italy 27100
9 Arcispedale Santa Maria Nuova Reggio Emilia RE Italy 43123
10 Ospedale di Castelfranco Veneto Castelfranco Veneto Treviso Italy 31033
11 Presidio Ospedaliero di Conegliano Conegliano Treviso Italy 31015
12 Ospedale di Circolo Fondazione Macchi Varese VA Italy 21100
13 Ospedale Sant'Andrea La Spezia Italy 19100
14 Policlinico Le Scotte Siena Italy 53100

Sponsors and Collaborators

  • Abbott Medical Devices

Investigators

  • Study Chair: Massimo Fineschi, MD, Policlinico Le Scotte, Siena
  • Study Chair: Marco Valgimigli, MD,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Abbott Medical Devices
ClinicalTrials.gov Identifier:
NCT02325973
Other Study ID Numbers:
  • CV-12-018-IT-PW
First Posted:
Dec 25, 2014
Last Update Posted:
Jul 24, 2020
Last Verified:
Jul 1, 2020
Keywords provided by Abbott Medical Devices
STEMI
IMR
FFR
microcirculatory
Additional relevant MeSH terms:
Coronary Artery Disease
ST Elevation Myocardial Infarction

Study Results

No Results Posted as of Jul 24, 2020