Efficacy and Safety Study of Deferred Stenting in Patients With STEMI
INNOVATION
Impact of Immediate Stent Implantation Versus Deferred Stent Implantation on Infarct Size and Microvascular Perfusion in Patients With ST-segment Elevation Myocardial Infarction
1 other identifier
interventional
114
1 country
1
Brief Summary
It is known that no reflow phenomenon by microvascular obstruction after revascularization in STEMI increase infarct size, cardiac remodeling, and a risk of late mortality. Major mechanism of microvascular obstruction is distal embolization during procedure. Some investigators showed deferred stenting decreased the degree of microvascular obstruction compared with immediate stenting in STEMI. The aim of current study is to compare impact of immediate stent implantation versus deferred stent implantation on infarct size and microvascular perfusion in patients with ST-segment elevation myocardial infarction (STEMI).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 26, 2014
CompletedFirst Posted
Study publicly available on registry
December 24, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedNovember 18, 2015
November 1, 2015
1.9 years
August 26, 2014
November 16, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Infarct size measured by cardiac magnetic resonance image (MRI)
Post MI 30 days
Secondary Outcomes (7)
Microvascular obstruction (MVO) volume measured by cardiac MRI
Post MI 30 days
Ratio of MVO volume to infarct size
Post MI 30 days
Enzymatic infarct size
Post MI 30 days
Degree of resolution of ST-segment elevation
1 hour after coronary stenting
CTFC (corrected TIMI frame count)
Immediately after coronary stenting
- +2 more secondary outcomes
Other Outcomes (3)
Left ventricle (LV) ejection fraction
Post MI 6 months
Left ventricle (LV) remodelling index
Post MI 6 months
MACCE (major adverse cardiac and cerebrovascular event)
Post MI 1, 6, 12 month
Study Arms (2)
Immediate coronary stenting
PLACEBO COMPARATORWithin enrolled patients who agreed to participate in the study, signed informed consent and being satisfied with inclusion and exclusion criteria, stent implantation is done on the initial procedure in immediate coronary stenting group
Deferred coronary stenting
ACTIVE COMPARATORWithin enrolled patients who agreed to participate in the study, signed informed consent and being satisfied with inclusion and exclusion criteria, only TIMI Ⅲ flow achievement is done on the initial procedure and stent implantation is deferred after 5-7 days admission in the deferred coronary stenting group.
Interventions
Abciximab (0.25㎎/㎏) intracoronary injection will be performed to all possible patients after guidewire has passed culprit lesion. Additional manual thrombus aspiration or balloon angioplasty can be performed by operator to achieve TIMI Ⅲ flow. When TIMI Ⅲ flow is achieved after these procedures, patient will be randomized to immediate stenting or deferred stenting group. In deferred stenting group, second stage procedure (stent implantation) will be done at 5 to 7 days after TIMI Ⅲ flow has achieved.
Abciximab (0.25㎎/㎏) intracoronary injection will be performed to all possible patients after guidewire has passed culprit lesion. Additional manual thrombus aspiration or balloon angioplasty can be performed by operator to achieve TIMI Ⅲ flow. When TIMI Ⅲ flow is achieved after these procedures, patient will be randomized to immediate stenting or deferred stenting group. In immediate stenting group, stenting will be done immediate after achieving TIMI III flow during initial procedure.
Eligibility Criteria
You may qualify if:
- years of age or older
- more than 30 minutes of duration of typical chest pain
- mm or more of ST elevation on 2 or more continuous leads
- chest pain within 12 hours
- Thrombolysis In Myocardial Infarction (TIMI) flow 0, Ⅰ or Ⅱ before procedure
- TIMI Ⅲ flow after balloon angioplasty, intracoronary abciximab infusion, or thrombus aspiration
- accepted informed consent
You may not qualify if:
- cardiogenic shock
- previous history of myocardiac infarction, or coronary artery bypass graft
- rescue percutaneous coronary intervention after fibrinolysis
- life expectancy \< 1 year
- left main disease (included if left main lesion is not infarct related artery)
- contraindication to cardiac MRI
- STEMI due to stent thrombosis
- anticipated risk of acute closure when assigned as deferred stenting group in the condition major dissection (type C\~F) has occurred during procedure achieving TIMI flow involving balloon angioplasty
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Korea University Anam Hospitallead
- Terumo Corporationcollaborator
Study Sites (1)
Korea University Anam Hospital
Seoul, 136-705, South Korea
Related Publications (2)
Kook H, Lee HJ, Kim MN, Yu CW, Kim JS, Joo HJ, Park JH, Hong SJ, Kim TH, Jang HJ, Park JS, Choi RK, Choi YJ, Kim YM, Lim DS, Ro YM. Effects of deferred versus immediate stenting on left ventricular function in patients with ST elevation myocardial infarction. Medicine (Baltimore). 2021 Jul 16;100(28):e26598. doi: 10.1097/MD.0000000000026598.
PMID: 34260542DERIVEDKim 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: 27965296DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cheol Woong Yu, M.D.,Ph.D.
Cardiovascular center, Korea university Anam hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 26, 2014
First Posted
December 24, 2014
Study Start
June 1, 2013
Primary Completion
May 1, 2015
Study Completion
July 1, 2015
Last Updated
November 18, 2015
Record last verified: 2015-11