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

This study is currently recruiting participants.
Verified October 2011 by Università degli Studi di Ferrara
Sponsor:
Information provided by (Responsible Party):
Marco Valgimigli, Università degli Studi di Ferrara
ClinicalTrials.gov Identifier:
NCT01462188
First received: October 24, 2011
Last updated: October 28, 2011
Last verified: October 2011
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • infarct size [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    Infarct size will be quantified by MRI

  • Infarct size [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Infarct size will be quantified by MRI

  • microvascular obstruction [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    microvascular obstruction will be quantified by MRI

  • microvascular obstruction [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    microvascular obstruction will be quantified by MRI

  • Mortality [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01462188

Contacts
Contact: Alessandro Dal Monte, MD 3487243479 ext +39 dalmo_it@yahoo.it
Contact: Marco Valgimigli, MD, PhD 3356478877 ext +39 vlgmrc@unife.it

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

No publications provided

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

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

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013