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

Immediate Versus Delayed Stenting in Patients With ST-Elevation Myocardial Infarction Undergoing Mechanical Intervention

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.

Study Overview

• Status: Unknown
• Conditions: Myocardial Infarction
• Intervention / Treatment: Procedure: Immediate stenting; Procedure: Delayed stenting

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: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Emilia Romagna
    • Ferrara, Emilia Romagna, Italy, 44100
      • Recruiting
      • U.O. Cardiologia
      • Contact: Alessandro Dal Monte, MD; Phone Number: +39 3487243479; Email: dalmo_it@yahoo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myocardial blush grade (MBG) equal or greater than 2	The MBG will be estimated visually by 2 experienced observers, as previously described.	post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ST segment elevation resolution	Cumulative ST segment elevation in all leads will be quantified before and after the procedure and expressed as percentage	30 minutes after the procedure
ST segment elevation Resolution		90 minutes after the procedure
infarct size	Infarct size will be quantified by MRI	5 days
Infarct size	Infarct size will be quantified by MRI	6 months
microvascular obstruction	microvascular obstruction will be quantified by MRI	5 days
microvascular obstruction	microvascular obstruction will be quantified by MRI	6 months
Mortality	overall and cardiac mortality will be assessed up to 6 months	6 months

Collaborators and Investigators

• Sponsor: Marco Valgimigli

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Anticipated): October 1, 2012
• Study Completion (Anticipated): October 1, 2015

Study Registration Dates

• First Submitted: October 24, 2011
• First Submitted That Met QC Criteria: October 28, 2011
• First Posted (Estimate): October 31, 2011

Study Record Updates

• Last Update Posted (Estimate): October 31, 2011
• Last Update Submitted That Met QC Criteria: October 28, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: ST-segment elevation myocardial infarction; stent; Primary angioplasty
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: TRAPS-09-I