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Optimizing Infarct Size by Transforming Emergent Stenting Into an Elective Procedure Study (OPTIMASTRATEGY)

Primary Purpose

Myocardial Infarction

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Immediate stenting
Delayed stenting
Sponsored by
Marco Valgimigli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring ST-segment elevation myocardial infarction, Primary angioplasty, stent

Eligibility Criteria

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

Inclusion Criteria:

  • chest pain for >30 min with ST-segment elevation of one mm or more in 2 or more contiguous ECG leads or with presumably new left bundle-branch block
  • admission either within 12 h of symptom onset or between 12 and 24 h with evidence of continuing ischaemia

Exclusion Criteria:

  • the exclusion criteria will include history of bleeding diathesis or documented allergy/intolerance or contraindication to clopidogrel or ticlopidine or prasugrel
  • inability to assume an oral P2Y12 receptor blocker on a consecutive daily basis for a minimum of 6 months, or to heparin or aspirin
  • uncontrolled hypertension (systolic or diastolic arterial pressure >180 mmHg or 120, respectively, despite medical therapy)
  • limited life expectancy, e.g. neoplasms, others
  • inability to obtain informed consent
  • pregnancy
  • patients were not enrolled if they were clinically unstable, presented with severe arrhythmia, or had known contraindications to CMR (claustrophobia, pacemakers, or implantable defibrillator devices)

Sites / Locations

  • U.O. CardiologiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Immediate stenting

Delayed stenting

Arm Description

Patients being randomized to the immediate stenting arm will be managed according to the guidelines. Irrespective of TIMI flow at presentation, investigators will be requested to thrombus aspirate immediately after successful wiring of the culprit vessel followed by direct stenting. In cases where insertion of thrombus removal catheter and/or direct stenting is not successful, balloon angioplasty will be allowed.

Patients being randomized to the delayed/staged stenting arm will be managed with the aim to obtain stable TIMI 3 flow with no considerations given at the percentage of residual stenosis at the culprit lesion. In patients presenting with TIMI 3 flow, investigators will be left free to wire the vessel and proceed to thrombus aspiration to decrease thrombus burden in the culprit lesion or to leave the vessel untreated at the time of index PCI. Patients presenting with suboptimal TIMI flow (i.e. less than 3), investigators are required to wire the vessel and thrombus aspirate. If stable (persisting for at least 5 minutes) TIMI 3 flow is obtained, investigators are requested to stop the procedure. The goal is to achieve s table TIMI 3 flow with no considerations given to the percentage of residual stenosis. Stenting in this arm will be allowed only on a bail-out strategy.

Outcomes

Primary Outcome Measures

Myocardial blush grade (MBG) equal or greater than 2
The MBG will be estimated visually by 2 experienced observers, as previously described.

Secondary Outcome Measures

ST segment elevation resolution
Cumulative ST segment elevation in all leads will be quantified before and after the procedure and expressed as percentage
ST segment elevation Resolution
infarct size
Infarct size will be quantified by MRI
Infarct size
Infarct size will be quantified by MRI
microvascular obstruction
microvascular obstruction will be quantified by MRI
microvascular obstruction
microvascular obstruction will be quantified by MRI
Mortality
overall and cardiac mortality will be assessed up to 6 months

Full Information

First Posted
October 24, 2011
Last Updated
October 28, 2011
Sponsor
Marco Valgimigli
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1. Study Identification

Unique Protocol Identification Number
NCT01462188
Brief Title
Optimizing Infarct Size by Transforming Emergent Stenting Into an Elective Procedure Study
Acronym
OPTIMASTRATEGY
Official Title
Immediate Versus Delayed Stenting in Patients With ST-Elevation Myocardial Infarction Undergoing Mechanical Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Unknown status
Study Start Date
October 2011 (undefined)
Primary Completion Date
October 2012 (Anticipated)
Study Completion Date
October 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marco Valgimigli

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of primary PCI is to restore anterograde myocardial flow. Stenting a largely thrombotic lesion may determine distal embolisation of thrombotic material therefore deteriorating myocardial perfusion.
Detailed Description
In the setting of largely thrombotic lesions such as those treated in the context of primary PCI, stenting often results in distal micro and macro-embolisation which hampers coronary flow and microvascular recovery. Interestingly in some of these studies comparing BMS versus balloon angioplasty an early hazard associated to the use of stent has been reported. Thus, investigators hypothesize in this protocol that refraining from stenting during the acute phase of ST segment myocardial infarction is safe and associated to improved myocardial recovery as compared to acute stenting.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
ST-segment elevation myocardial infarction, Primary angioplasty, stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immediate stenting
Arm Type
Active Comparator
Arm Description
Patients being randomized to the immediate stenting arm will be managed according to the guidelines. Irrespective of TIMI flow at presentation, investigators will be requested to thrombus aspirate immediately after successful wiring of the culprit vessel followed by direct stenting. In cases where insertion of thrombus removal catheter and/or direct stenting is not successful, balloon angioplasty will be allowed.
Arm Title
Delayed stenting
Arm Type
Experimental
Arm Description
Patients being randomized to the delayed/staged stenting arm will be managed with the aim to obtain stable TIMI 3 flow with no considerations given at the percentage of residual stenosis at the culprit lesion. In patients presenting with TIMI 3 flow, investigators will be left free to wire the vessel and proceed to thrombus aspiration to decrease thrombus burden in the culprit lesion or to leave the vessel untreated at the time of index PCI. Patients presenting with suboptimal TIMI flow (i.e. less than 3), investigators are required to wire the vessel and thrombus aspirate. If stable (persisting for at least 5 minutes) TIMI 3 flow is obtained, investigators are requested to stop the procedure. The goal is to achieve s table TIMI 3 flow with no considerations given to the percentage of residual stenosis. Stenting in this arm will be allowed only on a bail-out strategy.
Intervention Type
Procedure
Intervention Name(s)
Immediate stenting
Intervention Description
Primary coronary stenting
Intervention Type
Procedure
Intervention Name(s)
Delayed stenting
Intervention Description
Coronary stenting 3 to 7 days after having reopened the vessel in the acute phase
Primary Outcome Measure Information:
Title
Myocardial blush grade (MBG) equal or greater than 2
Description
The MBG will be estimated visually by 2 experienced observers, as previously described.
Time Frame
post-procedure
Secondary Outcome Measure Information:
Title
ST segment elevation resolution
Description
Cumulative ST segment elevation in all leads will be quantified before and after the procedure and expressed as percentage
Time Frame
30 minutes after the procedure
Title
ST segment elevation Resolution
Time Frame
90 minutes after the procedure
Title
infarct size
Description
Infarct size will be quantified by MRI
Time Frame
5 days
Title
Infarct size
Description
Infarct size will be quantified by MRI
Time Frame
6 months
Title
microvascular obstruction
Description
microvascular obstruction will be quantified by MRI
Time Frame
5 days
Title
microvascular obstruction
Description
microvascular obstruction will be quantified by MRI
Time Frame
6 months
Title
Mortality
Description
overall and cardiac mortality will be assessed up to 6 months
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: chest pain for >30 min with ST-segment elevation of one mm or more in 2 or more contiguous ECG leads or with presumably new left bundle-branch block admission either within 12 h of symptom onset or between 12 and 24 h with evidence of continuing ischaemia Exclusion Criteria: the exclusion criteria will include history of bleeding diathesis or documented allergy/intolerance or contraindication to clopidogrel or ticlopidine or prasugrel inability to assume an oral P2Y12 receptor blocker on a consecutive daily basis for a minimum of 6 months, or to heparin or aspirin uncontrolled hypertension (systolic or diastolic arterial pressure >180 mmHg or 120, respectively, despite medical therapy) limited life expectancy, e.g. neoplasms, others inability to obtain informed consent pregnancy patients were not enrolled if they were clinically unstable, presented with severe arrhythmia, or had known contraindications to CMR (claustrophobia, pacemakers, or implantable defibrillator devices)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alessandro Dal Monte, MD
Phone
3487243479
Ext
+39
Email
dalmo_it@yahoo.it
First Name & Middle Initial & Last Name or Official Title & Degree
Marco Valgimigli, MD, PhD
Phone
3356478877
Ext
+39
Email
vlgmrc@unife.it
Facility Information:
Facility Name
U.O. Cardiologia
City
Ferrara
State/Province
Emilia Romagna
ZIP/Postal Code
44100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandro Dal Monte, MD
Phone
3487243479
Ext
+39
Email
dalmo_it@yahoo.it

12. IPD Sharing Statement

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Optimizing Infarct Size by Transforming Emergent Stenting Into an Elective Procedure Study

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