Index of Microcirculatory Resistance After Immediate Versus Deferred Stenting in Patients With Acute Myocardial Infarction

• Conditions: Acute Myocardial Infarction
• Interventions: Procedure: Deferred stenting

• Registration Number: NCT03238508
• Lead Sponsor: Sejong General Hospital

Brief Summary

This study will compare the microcirculatory resistance (IMR) of infarct-related artery (IRA) in patients who underwent immediate versus deferred stenting during percutaneous coronary intervention (PCI) for acute myocardial infarction.

Detailed Description

Primary PCI with immediate stenting (IS) is the current standard of reperfusion strategy for STEMI. However, it is thought that IS may cause additional myocardial injury by increasing distal embolization of clot and atheromatous plaque debris. Only about 35% of patients without cardiogenic shock can achieve optimal myocardial tissue perfusion at the microvascular level, even after restoration of epicardial coronary artery patency. IS in highly pro-thrombotic and inflammatory milieu of IRA during primary PCI would increase distal embolization of clot and atheromatous plaque debris, and provoke the inflammation process, so deferred stenting after a cooling down period of IRA for several days, have a potential to mitigate or prevent microvascular obstruction (MVO). Among several methods to evaluate MVO after STEMI, IMR has been well known as an good indicator of MVO and strong predictor for short and long term clinical outcomes.

Study Timeline

• Study Start: 2013-01-01
• Status Verified: 2017-08
• Study First Submitted: 2017-08-01
• Study First Submitted QC: 2017-08-02
• Study First Posted: 2017-08-03
• Last Update Submitted: 2017-08-07
• Last Update Posted: 2017-08-08
• Primary Completion: 2017-08-30
• Study Completion: 2017-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. More than 30 minutes in duration of typical chest pain
2. Thrombolysis In Myocardial Infarction (TIMI) flow 0, 1 or 2 prior to the procedure

Exclusion Criteria

1. Cardiogenic shock,
2. Previous history of myocardial infarction, or coronary artery bypass surgery
3. Rescue PCI after fibrinolysis
4. Life expectancy of less than 1 year
5. Acute occlusion of left main coronary artery
6. STEMI due to stent thrombosis
7. Major coronary dissection (type D~F) following procedures achieving TIMI 3 flow

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Deferred stenting group	Deferred stenting	Elective stenting following cooling down of infarct- related artery for several days after restoration of epicardial coronary blood flow during primary PCI

Primary Outcome Measures

Name	Time	Method
Index of microcirculatory resistance of infarct-related artery	3 to 5 days after primary reperfusion (TIMI 3 flow achievement) in both groups	Measured by pressure and temperature sensors- tipped guide wire

Secondary Outcome Measures

Name	Time	Method
The rate of urgent revascularization	During index hospitalization (intraoperative)
Major bleeding	During index hospitalization (intraoperative)	Defined as TIMI bleeding criteria
Major adverse cardiac events	One- year after primary reperfusion	Death, myocardial infarction, unplanned target vessel revascularization or CHF admission

Trial Locations

Locations (1)

Sejong general hospital, 91-121 Sosa 2-Dong, Sosa-Gu; 🇰🇷 Bucheon, Gyeonggi, Korea, Republic of