NCT03238508

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2017

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
Last Updated

August 8, 2017

Status Verified

August 1, 2017

Enrollment Period

4.7 years

First QC Date

August 1, 2017

Last Update Submit

August 7, 2017

Conditions

Acute Myocardial Infarction

Keywords

Deferred stentingMicrovascular dysfunction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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 Arms (2)

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

Deferred stentingPROCEDURE

Previously described

Deferred stenting group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Bucheon-si, Gyeonggi-do, 422-711, South Korea

RECRUITING

Related 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):e004101. doi: 10.1161/CIRCINTERVENTIONS.116.004101.

    PMID: 27965296BACKGROUND

Study Officials

  • Hyun Jong Lee, MD

    Sejong General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyun Jong Lee, MD

CONTACT

82-32-340-1812untouchables@sejongh.co.kr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

August 1, 2017

First Posted

August 3, 2017

Study Start

January 1, 2013

Primary Completion

August 30, 2017

Study Completion

September 30, 2017

Last Updated

August 8, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)