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

Phase 4

• Conditions: Myocardial Infarction
• Interventions: Procedure: Immediate stenting; Procedure: Delayed stenting

• Registration Number: NCT01462188
• Lead Sponsor: Marco Valgimigli

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 Timeline

• Status Verified: 2011-10
• Study Start: 2011-10
• Study First Submitted: 2011-10-24
• Study First Submitted QC: 2011-10-28
• Last Update Submitted: 2011-10-28
• Study First Posted: 2011-10-31
• Last Update Posted: 2011-10-31
• Primary Completion: 2012-10
• Study Completion: 2015-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate stenting	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.
Delayed stenting	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
ST segment elevation resolution	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	90 minutes after the procedure
infarct size	5 days	Infarct size will be quantified by MRI
Infarct size	6 months	Infarct size will be quantified by MRI
microvascular obstruction	6 months	microvascular obstruction will be quantified by MRI
Mortality	6 months	overall and cardiac mortality will be assessed up to 6 months

Trial Locations

Locations (1)

U.O. Cardiologia; 🇮🇹 Ferrara, Emilia Romagna, Italy