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Status unknownNCT03238508Updated Aug 8, 2017

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

An observational study in Acute Myocardial Infarction, sponsored by Sejong General Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-08-08.

Sponsored by Sejong General Hospital · Observational

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 80 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Acute Myocardial Infarction

Keywords

  • Deferred stenting
  • Microvascular dysfunction
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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
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

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

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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
60 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • 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

Interventions

  • ProcedureDeferred stenting

    Previously described

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What researchers measure

Primary outcomes

  1. Index of microcirculatory resistance of infarct-related artery

    Measured by pressure and temperature sensors- tipped guide wire

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

Secondary outcomes

  1. The rate of urgent revascularization

    Time frame: During index hospitalization (intraoperative)

  2. Major bleeding

    Defined as TIMI bleeding criteria

    Time frame: During index hospitalization (intraoperative)

  3. Major adverse cardiac events

    Death, myocardial infarction, unplanned target vessel revascularization or CHF admission

    Time frame: One- year after primary reperfusion

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Study locations

1 of 1 sites recruiting
  • Sejong general hospital, 91-121 Sosa 2-Dong, Sosa-Gu
    Bucheon, Gyeonggi 422-711, Korea, Republic of
    Recruiting
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References and documents

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. PubMed 27965296 ↗

Individual participant data

Plan to share: No

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Registry details

Key details

Study ID
NCT03238508
Lead sponsor
Sejong General Hospital
Responsible party
Hyun Jong Lee (Principle Investigator, Sejong General Hospital) — Principal investigator
First posted
Aug 3, 2017
Start date
Jan 1, 2013
Primary completion
Aug 30, 2017 (estimated)
Completion
Sep 30, 2017 (estimated)
Last update
Aug 8, 2017

Study contacts

Hyun Jong Lee, MD
Contact
untouchables@sejongh.co.kr
82-32-340-1812
Hyun Jong Lee, MD
principal investigator · Sejong General Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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