Efficacy and Safety Study of Deferred Stenting in Patients With STEMI (INNOVATION)

November 16, 2015 updated by: Dr. Cheol Woong Yu, Korea University Anam Hospital

Impact of Immediate Stent Implantation Versus Deferred Stent Implantation on Infarct Size and Microvascular Perfusion in Patients With ST-segment Elevation Myocardial Infarction

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. Patients will be enrolled if they agree to participate in the study and sign informed consent among patients who are satisfied with inclusion and exclusion criteria. Acceptance of the study will be taken concurrently at the situation when the patient admitted via emergency department with the diagnosis of STEMI and informed consent of primary coronary angiography and intervention is taken. Considering emergent situation of the procedure, it is thought to be impossible to take informed consent of the study before procedure and after achieving TIMI flow. Duty operator will inform to the patient when taking informed consent of primary coronary angiography and intervention that the patient will be randomized to immediate coronary stenting group or deferred coronary stent group, and explain about theoretical background of deferred coronary stenting. To all patients, aspirin 300㎎, clopidogrel 600㎎ are administered orally and heparin intravenously until achieving ACT (activated clotting time) between 200 and 250 seconds. Maximal total dose of unfractionated heparin of 100 unit/㎏ will be administered before intervention.
  2. Transradial or transfemoral approach will be determined on operator's decision. Flow of the infarct related artery (IRA) will be checked as total occlusion, TIMI 0, Ⅰ or Ⅱ after coronary angiography.
  3. 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.
  4. Although stent implantation without balloon angioplasty is preferred in immediate stenting group, balloon angioplasty can be performed to achieve distal flow. In deferred stenting group, second stage procedure (stent implantation) will be done at 5 to 7 days after TIMI Ⅲ flow has achieved.
  5. On coronary intervention (stent implantation), all possible cases will be implanted with Nobori Biolimus A9-eluting coronary stent (Terumo, Tokyo, Japan). (Other stents can be used if the length of the lesion cannot be covered with Nobori stent.)
  6. In both group, abciximab continuous intravenous infusion on a dose of 0.125 ㎍/㎏/min (maximum dose 10 ㎍/min) will be done after initial procedure if possible. (Intracoronary injection and intravenous infusion of abciximab should be done unless there is no contraindication of abciximab.)
  7. In both group, subcutaneous enoxaparin (low molecular weight heparin) injection will be done twice daily until 3 days after procedure if possible. In case of stent implantation in the fifth to seventh day within deferred coronary stenting group, enoxaparin injection can be extended until deferred intervention.
  8. Transradial and transfemoral approach are all possible. If procedure is done with transfemoral approach, sheath removal will be done after continuous intravenous abciximal infusion of 12 hours and enoxaparin injection after hemostasis has been confirmed.
  9. In case of residual stenosis of IRA is below 30% within deferred coronary stenting group, intravascular ultrasonography (IVUS) will be performed at the secondary procedure and withdrawal of stenting can be done upon operator's discretion.
  10. In case of multivessel disease, intervention of non-IRA will be deferred in both groups. Therefore, PCI on IRA and non-IRA will be done concurrently in deferred coronary stenting group.
  11. Patient will maintain dual antiplatelet therapy of aspirin 100㎎ and clopidogrel 75㎎ after PCI.
  12. Among prescribed drugs after PCI, statin agent can be used upon operator's discretion.
  13. Cardiac MRI is done on the period of 30±7 days after diagnosed as STEMI in both group.
  14. Follow-up period is 1 month ± 1 week, 6 month ± 4 week, and 12 month ± 4 week in both group. Transthoracic echocardiography will be done at 6 month ± 4 week follow-up period.

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years of age or older
  • more than 30 minutes of duration of typical chest pain
  • 1mm 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Immediate coronary stenting
Within 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
Procedure: Immediate coronary stenting
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.
Active Comparator: Deferred coronary stenting
Within 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.
Procedure: Deferred coronary stenting
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Infarct size measured by cardiac magnetic resonance image (MRI)
Time Frame: Post MI 30 days
Post MI 30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Microvascular obstruction (MVO) volume measured by cardiac MRI
Time Frame: Post MI 30 days
Post MI 30 days
Ratio of MVO volume to infarct size
Time Frame: Post MI 30 days
Post MI 30 days
Enzymatic infarct size
Time Frame: Post MI 30 days
Post MI 30 days
Degree of resolution of ST-segment elevation
Time Frame: 1 hour after coronary stenting
1 hour after coronary stenting
CTFC (corrected TIMI frame count)
Time Frame: Immediately after coronary stenting
Immediately after coronary stenting
Myocardial brush grade
Time Frame: Immediately after coronary stenting
Immediately after coronary stenting
Rate of slow flow or no reflow phenomenon (TIMI flow≤2)
Time Frame: Immediately after coronary stenting
Immediately after coronary stenting

Other Outcome Measures

Outcome Measure
Time Frame
Left ventricle (LV) ejection fraction
Time Frame: Post MI 6 months
Post MI 6 months
Left ventricle (LV) remodelling index
Time Frame: Post MI 6 months
Post MI 6 months
MACCE (major adverse cardiac and cerebrovascular event)
Time Frame: Post MI 1, 6, 12 month
Post MI 1, 6, 12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea University Anam Hospital

Collaborators

Terumo Corporation

Investigators

  • Principal Investigator: Cheol Woong Yu, M.D.,Ph.D., Cardiovascular center, Korea University Anam Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

August 26, 2014

First Submitted That Met QC Criteria

December 18, 2014

First Posted (Estimate)

December 24, 2014

Study Record Updates

Last Update Posted (Estimate)

November 18, 2015

Last Update Submitted That Met QC Criteria

November 16, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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