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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. 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
Information provided by (Responsible Party):
Marco Valgimigli, Università degli Studi di Ferrara

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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Procedure: Immediate stenting Procedure: Delayed stenting Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Immediate Versus Delayed Stenting in Patients With ST-Elevation Myocardial Infarction Undergoing Mechanical Intervention
Study Start Date : October 2011
Estimated Primary Completion Date : October 2012
Estimated Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
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.
Procedure: Immediate stenting
Primary coronary 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.

Procedure: Delayed stenting
Coronary stenting 3 to 7 days after having reopened the vessel in the acute phase

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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

  2. ST segment elevation Resolution [ Time Frame: 90 minutes after the procedure ]
  3. infarct size [ Time Frame: 5 days ]
    Infarct size will be quantified by MRI

  4. Infarct size [ Time Frame: 6 months ]
    Infarct size will be quantified by MRI

  5. microvascular obstruction [ Time Frame: 5 days ]
    microvascular obstruction will be quantified by MRI

  6. microvascular obstruction [ Time Frame: 6 months ]
    microvascular obstruction will be quantified by MRI

  7. Mortality [ Time Frame: 6 months ]
    overall and cardiac mortality will be assessed up to 6 months

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01462188

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Contact: Alessandro Dal Monte, MD 3487243479 ext +39
Contact: Marco Valgimigli, MD, PhD 3356478877 ext +39

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U.O. Cardiologia Recruiting
Ferrara, Emilia Romagna, Italy, 44100
Contact: Alessandro Dal Monte, MD    3487243479 ext +39   
Sponsors and Collaborators
Marco Valgimigli

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Responsible Party: Marco Valgimigli, Head of the Catheterization laboratory, Università degli Studi di Ferrara Identifier: NCT01462188    
Other Study ID Numbers: TRAPS-09-I
First Posted: October 31, 2011    Key Record Dates
Last Update Posted: October 31, 2011
Last Verified: October 2011
Keywords provided by Marco Valgimigli, Università degli Studi di Ferrara:
ST-segment elevation myocardial infarction
Primary angioplasty
Additional relevant MeSH terms:
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Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases