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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2011 by Università degli Studi di Ferrara.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Marco Valgimigli, Università degli Studi di Ferrara Identifier:
First received: October 24, 2011
Last updated: October 28, 2011
Last verified: October 2011
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 Intervention Phase
Myocardial Infarction
Procedure: Immediate stenting
Procedure: Delayed stenting
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Immediate Versus Delayed Stenting in Patients With ST-Elevation Myocardial Infarction Undergoing Mechanical Intervention

Resource links provided by NLM:

Further study details as provided by Università degli Studi di Ferrara:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 100
Study Start Date: October 2011
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01462188

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

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

Responsible Party: Marco Valgimigli, Head of the Catheterization laboratory, Università degli Studi di Ferrara Identifier: NCT01462188     History of Changes
Other Study ID Numbers: TRAPS-09-I
Study First Received: October 24, 2011
Last Updated: October 28, 2011

Keywords provided by Università degli Studi di Ferrara:
ST-segment elevation myocardial infarction
Primary angioplasty

Additional relevant MeSH terms:
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases processed this record on May 23, 2017