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

NCT ID: NCT03238508

Last Updated: 2017-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-01

Study Completion Date

2017-09-30

Brief Summary

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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

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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.

Conditions

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Acute Myocardial Infarction

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Immediate stenting group

Conventional stenting immediate after the re-opening of infarct-related artery during primary PCI

No interventions assigned to this group

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

Deferred stenting

Intervention Type PROCEDURE

Previously described

Interventions

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Deferred stenting

Previously described

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sejong General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hyun Jong Lee

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hyun Jong Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Sejong General Hospital

Locations

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Sejong general hospital, 91-121 Sosa 2-Dong, Sosa-Gu

Bucheon-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hyun Jong Lee, MD

Role: CONTACT

82-32-340-1812

Facility Contacts

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Hyun-Jong Lee, MD

Role: primary

82-32-340-1812

References

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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.

Reference Type BACKGROUND
PMID: 27965296 (View on PubMed)

Other Identifiers

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Sejong_IRB_1732

Identifier Type: -

Identifier Source: org_study_id

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