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

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.

Study Overview

• Status: Unknown
• Conditions: Acute Myocardial Infarction
• Intervention / Treatment: Procedure: Deferred stenting

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 Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Hyun Jong Lee, MD; Phone Number: 82-32-340-1812; Email: untouchables@sejongh.co.kr

Study Locations

• Korea, Republic of
  • Gyeonggi
    • Bucheon, Gyeonggi, Korea, Republic of, 422-711
      • Recruiting
      • Sejong general hospital, 91-121 Sosa 2-Dong, Sosa-Gu
      • Contact: Hyun-Jong Lee, MD; Phone Number: 82-32-340-1812; Email: untouchables@sejongh.co.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing primary precutaneous coronary intervention for ST- segment elevation or Non ST-segment elevation myocardial infarcation with ongoing myocardial ischemia

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Immediate stenting group; Conventional stenting immediate after the re-opening of infarct-related artery during primary PCI
Deferred stenting group; Elective stenting following cooling down of infarct- related artery for several days after restoration of epicardial coronary blood flow during primary PCI	Procedure: Deferred stenting; Previously described

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sejong General Hospital
• Investigators: Principal Investigator: Hyun Jong Lee, MD, Sejong General Hospital

Publications and helpful links

General Publications

• Kim JS, Lee HJ, Woong Yu C, Kim YM, Hong SJ, Park JH, Choi RK, Choi YJ, Park JS, Kim TH, Jang HJ, Joo HJ, Cho SA, Ro YM, Lim DS. INNOVATION Study (Impact of Immediate Stent Implantation Versus Deferred Stent Implantation on Infarct Size and Microvascular Perfusion in Patients With ST-Segment-Elevation Myocardial Infarction). Circ Cardiovasc Interv. 2016 Dec;9(12):e004101. doi: 10.1161/CIRCINTERVENTIONS.116.004101.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Anticipated): August 30, 2017
• Study Completion (Anticipated): September 30, 2017

Study Registration Dates

• First Submitted: August 1, 2017
• First Submitted That Met QC Criteria: August 2, 2017
• First Posted (Actual): August 3, 2017

Study Record Updates

• Last Update Posted (Actual): August 8, 2017
• Last Update Submitted That Met QC Criteria: August 7, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Deferred stenting; Microvascular dysfunction
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: Sejong_IRB_1732

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No