ST-segment Elevation Myocardial InfarctionINNOVATIONNCT02324348
Efficacy and Safety Study of Deferred Stenting in Patients With STEMI
A study testing Deferred coronary stenting and Immediate coronary stenting in people with ST-segment Elevation Myocardial Infarction, run by Korea University Anam Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- ST-segment Elevation Myocardial Infarction
- What is being tested?
- Deferred coronary stenting and Immediate coronary stenting
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2013to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the detailed description
- 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.
- 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.
- 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.
- 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.
- 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.)
- 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.)
- 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.
- 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.
- 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.
- 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.
- Patient will maintain dual antiplatelet therapy of aspirin 100㎎ and clopidogrel 75㎎ after PCI.
- Among prescribed drugs after PCI, statin agent can be used upon operator's discretion.
- Cardiac MRI is done on the period of 30±7 days after diagnosed as STEMI in both group.
- 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.
- Being tested
- Deferred coronary stenting, Immediate coronary stenting
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deferred coronary stentingProcedure or surgery
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.
Immediate coronary stentingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate coronary stenting | Placebo comparator | 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 Receives: Procedure: Immediate coronary stenting |
| Deferred coronary stenting | Active comparator | 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. Receives: Procedure: Deferred coronary stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infarct size measured by cardiac magnetic resonance image (MRI)
Measured: Post MI 30 days
Secondary outcomes (7)
Microvascular obstruction (MVO) volume measured by cardiac MRI
Measured: Post MI 30 days
Ratio of MVO volume to infarct size
Measured: Post MI 30 days
Enzymatic infarct size
Measured: Post MI 30 days
Degree of resolution of ST-segment elevation
Measured: 1 hour after coronary stenting
CTFC (corrected TIMI frame count)
Measured: Immediately after coronary stenting
Myocardial brush grade
Measured: Immediately after coronary stenting
Rate of slow flow or no reflow phenomenon (TIMI flow≤2)
Measured: Immediately after coronary stenting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startJun 2013
- Primary completionMay 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ST-segment Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Terumo Corporation
- Responsible party
- Principal investigator, Dr. Cheol Woong Yu, Korea University Anam Hospital
- Investigators
- Cheol Woong Yu, M.D.,Ph.D., Principal investigator, Cardiovascular center, Korea university Anam hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02324348
- Sponsor's protocol ID
- 2012-3
- Acronym
- INNOVATION
- Status last verified
- Nov 2015
- First submitted
- 26 Aug 2014
- Last updated
- 18 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 34260542Kim 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Immediate Stent Implantation Versus Deferred Stent Implantation on Infarct Size and Microvascular Perfusion in Patients With ST-segment Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT02324348
- Acronym / sponsor ID
- INNOVATION / 2012-3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Collaborators
- Terumo Corporation
- Study start
- Jun 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 24 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
- 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.
- 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.
- 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.
- 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.
- 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.)
- 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.)
- 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.
- 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.
- 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.
- 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.
- Patient will maintain dual antiplatelet therapy of aspirin 100㎎ and clopidogrel 75㎎ after PCI.
- Among prescribed drugs after PCI, statin agent can be used upon operator's discretion.
- Cardiac MRI is done on the period of 30±7 days after diagnosed as STEMI in both group.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate coronary stenting | Placebo comparator | Procedure: Immediate coronary stentingWithin 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 comparator | Procedure: Deferred coronary stentingWithin 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deferred coronary stentingAbciximab (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. | Procedure or surgery | Deferred coronary stenting |
| Immediate coronary stentingAbciximab (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. | Procedure or surgery | Immediate coronary stenting |
Primary outcome
Infarct size measured by cardiac magnetic resonance image (MRI)
Time frame: Post MI 30 days
7 secondary outcomes
Microvascular obstruction (MVO) volume measured by cardiac MRI
Time frame: Post MI 30 days
Ratio of MVO volume to infarct size
Time frame: Post MI 30 days
Enzymatic infarct size
Time frame: Post MI 30 days
Degree of resolution of ST-segment elevation
Time frame: 1 hour after coronary stenting
CTFC (corrected TIMI frame count)
Time frame: Immediately after coronary stenting
Myocardial brush grade
Time frame: Immediately after coronary stenting
Rate of slow flow or no reflow phenomenon (TIMI flow≤2)
Time frame: Immediately after coronary stenting
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2015.
- Derived from this study: PubMed 34260542Kook 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.
- Derived from this study: PubMed 27965296Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheol Woong Yu, M.D.,Ph.D. principal investigator
Cardiovascular center, Korea university Anam hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deferred coronary stenting and Immediate coronary stenting in people with ST-segment Elevation Myocardial Infarction, run by Korea University Anam Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infarct size measured by cardiac magnetic resonance image (MRI) (time frame: Post MI 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02324348, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2015.