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Clinical Trials/NCT03238508
NCT03238508
Unknown
Not Applicable

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

Sejong General Hospital1 site in 1 country60 target enrollmentJanuary 1, 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Myocardial Infarction
Sponsor
Sejong General Hospital
Enrollment
60
Locations
1
Primary Endpoint
Index of microcirculatory resistance of infarct-related artery
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2013
End Date
September 30, 2017
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Sejong General Hospital
Responsible Party
Principal Investigator
Principal Investigator

Hyun Jong Lee

Principle Investigator

Sejong General Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Index of microcirculatory resistance of infarct-related artery

Time Frame: 3 to 5 days after primary reperfusion (TIMI 3 flow achievement) in both groups

Measured by pressure and temperature sensors- tipped guide wire

Secondary Outcomes

  • The rate of urgent revascularization(During index hospitalization (intraoperative))
  • Major bleeding(During index hospitalization (intraoperative))
  • Major adverse cardiac events(One- year after primary reperfusion)

Study Sites (1)

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