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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01462188
Recruitment Status : Unknown
Verified October 2011 by Marco Valgimigli, Università degli Studi di Ferrara.
Recruitment status was:  Recruiting
First Posted : October 31, 2011
Last Update Posted : October 31, 2011
Sponsor:
Information provided by (Responsible Party):
Marco Valgimigli, Università degli Studi di Ferrara

Tracking Information
First Submitted Date  ICMJE October 24, 2011
First Posted Date  ICMJE October 31, 2011
Last Update Posted Date October 31, 2011
Study Start Date  ICMJE October 2011
Estimated Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2011)
Myocardial blush grade (MBG) equal or greater than 2 [ Time Frame: post-procedure ]
The MBG will be estimated visually by 2 experienced observers, as previously described.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2011)
  • ST segment elevation resolution [ Time Frame: 30 minutes after the procedure ]
    Cumulative ST segment elevation in all leads will be quantified before and after the procedure and expressed as percentage
  • ST segment elevation Resolution [ Time Frame: 90 minutes after the procedure ]
  • infarct size [ Time Frame: 5 days ]
    Infarct size will be quantified by MRI
  • Infarct size [ Time Frame: 6 months ]
    Infarct size will be quantified by MRI
  • microvascular obstruction [ Time Frame: 5 days ]
    microvascular obstruction will be quantified by MRI
  • microvascular obstruction [ Time Frame: 6 months ]
    microvascular obstruction will be quantified by MRI
  • Mortality [ Time Frame: 6 months ]
    overall and cardiac mortality will be assessed up to 6 months
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Optimizing Infarct Size by Transforming Emergent Stenting Into an Elective Procedure Study
Official Title  ICMJE Immediate Versus Delayed Stenting in Patients With ST-Elevation Myocardial Infarction Undergoing Mechanical Intervention
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Myocardial Infarction
Intervention  ICMJE
  • Procedure: Immediate stenting
    Primary coronary stenting
  • Procedure: Delayed stenting
    Coronary stenting 3 to 7 days after having reopened the vessel in the acute phase
Study Arms  ICMJE
  • Active Comparator: Immediate stenting
    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.
    Intervention: Procedure: Immediate stenting
  • Experimental: Delayed stenting

    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: Procedure: Delayed stenting
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 28, 2011)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2015
Estimated Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01462188
Other Study ID Numbers  ICMJE TRAPS-09-I
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marco Valgimigli, Università degli Studi di Ferrara
Study Sponsor  ICMJE Marco Valgimigli
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Università degli Studi di Ferrara
Verification Date October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP