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

Myocardial Infarction Clinical Trial

— OPTIMASTRATEGY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01462188
• Other study ID #: TRAPS-09-I
• Status: Recruiting
• Phase: Phase 4
• First received: October 24, 2011
• Last updated: October 28, 2011
• Start date: October 2011
• Est. completion date: October 2015

Study information

• Verified date: October 2011
• Source: Università degli Studi di Ferrara
• Contact: Alessandro Dal Monte, MD
• Phone: 3487243479
• Email: dalmo_it[@]yahoo.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2015
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

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

Locations

Country	Name	City	State
Italy	U.O. Cardiologia	Ferrara	Emilia Romagna

Sponsors (1)

Lead Sponsor	Collaborator
Marco Valgimigli

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial blush grade (MBG) equal or greater than 2	The MBG will be estimated visually by 2 experienced observers, as previously described.	post-procedure	No
Secondary	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	No
Secondary	ST segment elevation Resolution		90 minutes after the procedure	No
Secondary	infarct size	Infarct size will be quantified by MRI	5 days	No
Secondary	Infarct size	Infarct size will be quantified by MRI	6 months	No
Secondary	microvascular obstruction	microvascular obstruction will be quantified by MRI	5 days	No
Secondary	microvascular obstruction	microvascular obstruction will be quantified by MRI	6 months	No
Secondary	Mortality	overall and cardiac mortality will be assessed up to 6 months	6 months	Yes