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

Acute Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03238508
• Other study ID #: Sejong_IRB_1732
• Status: Recruiting
• Phase: N/A
• First received: August 1, 2017
• Last updated: August 7, 2017
• Start date: January 1, 2013
• Est. completion date: September 30, 2017

Study information

• Verified date: August 2017
• Source: Sejong General Hospital
• Contact: Hyun Jong Lee, MD
• Phone: 82-32-340-1812
• Email: untouchables[@]sejongh.co.kr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 30, 2017
• Est. primary completion date: August 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Procedure:
• Deferred stenting
Previously described

Locations

Country	Name	City	State
Korea, Republic of	Sejong general hospital, 91-121 Sosa 2-Dong, Sosa-Gu	Bucheon	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
Sejong General Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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). pii: e004101. — View Citation

Outcome

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