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Deferred Stenting in Patients With Anterior Wall STEMI (INNOVATIONCORE)

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ClinicalTrials.gov Identifier: NCT03744000
Recruitment Status : Recruiting
First Posted : November 16, 2018
Last Update Posted : November 16, 2018
Sponsor:
Collaborators:
Abbott
Samjin Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Dr. Cheol Woong Yu, Korea University Anam Hospital

Brief Summary:

Trial Name) Impact of Immediate SteNt ImplaNtatiOn Versus Deferred Stent ImplAntaTION on Clinical Outcomes in Patients with AnteRior Wall ST-segment Elevation Myocardial Infarction (INNOVATION-CORE)

Objectives) To evaluate the impact of deferred versus immediate stenting in patients with acute ST-segment elevation anterior wall myocardial infarction (STEMI) on

  1. the clinical efficacy and safety
  2. the microvascular obstruction using Cardiac magnetic resonance (MR)
  3. the structural and functional cardiac remodeling using conventional echocardiography and strain imaging
  4. the intravascular findings using optical coherence tomography (OCT)

Study Design) A multicenter, prospective, randomized, controlled, open-label clinical trial for anterior wall STEMI patients

Patient Enrollment) 460 patients will be enrolled at 20 centers in South-Korea

Patient Follow-Up) Clinical follow-up will occur at 1, 6, 12 months, 2, 3 years and 5 years. Investigator or designee may conduct follow-up as telephone contacts or office visits.

Primary Endpoint) Composite of all-cause death, hospitalization due to heart failure, recurrent myocardial infarction (MI), target vessel revascularization (TVR) at 2 years.

Secondary Endpoints)

  1. Clinical events A. All-cause death B. Cardiac death C. Hospitalization due to heart failure D. Recurrent MI E. TVR F. Stent thrombosis
  2. Imaging parameters A. Echocardiographic parameters i. Left ventricle (LV) remodeling index ii. %LV strain iii. Regional wall motion abnormality B. Cardiac MR parameters (optional) i. Infarct size ii. Microvascular obstruction (MVO) size iii. MVO incidence iv. MVO to infarct ratio C. OCT parameters (optional) i. Plaque morphology ii. Lipid index iii. Minimal scaffold area and area stenosis iv. Stent malapposition

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction With ST Elevation Anterior Wall Myocardial Infarction Procedure: Immediate stenting Procedure: Deferred stenting Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 460 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Immediate Stent Implantation Versus Deferred Stent Implantation on Clinical Outcomes in Patients With Anterior Wall ST-segment Elevation Myocardial Infarction
Actual Study Start Date : April 3, 2018
Estimated Primary Completion Date : April 3, 2022
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Placebo Comparator: Immediate 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 stenting group.
Procedure: Immediate 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 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 for 3-7 days in the deferred stenting group.
Procedure: Deferred 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 3 to 7 days after TIMI Ⅲ flow has achieved.




Primary Outcome Measures :
  1. composite of all-cause death, hospitalization due to heart failure, recurrent MI, TVR, major adverse cardiovascular events (MACE) [ Time Frame: Initial admission date to last outpatient clinic visit or clinical outcome of interest occurs, whichever occur first, assessed up to 5 years ]

Secondary Outcome Measures :
  1. All-cause death [ Time Frame: Initial admission date to last outpatient clinic visit or clinical outcome of interest occurs, whichever occur first, assessed up to 5 years ]
  2. Cardiac death [ Time Frame: Initial admission date to last outpatient clinic visit or clinical outcome of interest occurs, whichever occur first, assessed up to 5 years ]
  3. Hospitalization due to heart failure [ Time Frame: Initial admission date to last outpatient clinic visit or clinical outcome of interest occurs, whichever occur first, assessed up to 5 years ]
  4. Recurrent MI [ Time Frame: Initial admission date to last outpatient clinic visit or clinical outcome of interest occurs, whichever occur first, assessed up to 5 years ]
  5. TVR [ Time Frame: Initial admission date to last outpatient clinic visit or clinical outcome of interest occurs, whichever occur first, assessed up to 5 years ]
  6. Stent thrombosis [ Time Frame: Initial admission date to last outpatient clinic visit or clinical outcome of interest occurs, whichever occur first, assessed up to 5 years ]
  7. MVO volume [ Time Frame: Post MI 30 days ]
  8. MVO incidence [ Time Frame: Post MI 30 days ]
  9. MVO to infarct size [ Time Frame: Post MI 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Typical ischemic chest pain lasting more than 30 minutes
  2. New ST elevation at the J point in two contiguous leads with the cut-points: ≥0.1 mV in all leads other than leads V2-V3 where the following cut-points apply: 0.2 ≥mV in men ≥40 years; ≥0.25 mV in men <40 years, or ≥0.15 mV in women27 or new left bundle branch block28.
  3. Symptom onset of chest pain within 6 hours
  4. If left anterior descending artery is culprit lesion on coronary angiography (Ostium to mid lesion). However, if the right coronary artery is hypoplastic and the distal portion of the left anterior descending artery feeds to the area of the posterior lower coronary artery (PDA), culprit lesion of the distal part of left anterior descending artery can also be included in the study.
  5. If TIMI blood flow before intervention is 0, 1 or 2
  6. If TIMI 3 blood flow was secured before coronary stenting by intracoronary abciximab injection, manual thrombus aspiration and balloon dilatation
  7. Patients who wrote the informed consent: The subject should be able to receive informations of treatment, risks, effects and other therapeutic modalities regarding staged percutaneous coronary intervention (PCI) at least verbally, and investigators should be provided written informed consent from a subject or a legally recognized representative prior to giving any treatment related to the study.

Exclusion Criteria:

  1. If there is a previous history of myocardial infarction or coronary artery bypass surgery
  2. Cardiogenic shock
  3. Rescue PCI after thrombolytic therapy
  4. If the life expectancy of the accompanying disease is expected to be less than one year or the patient is not cooperating with the protocol.
  5. In cases where the left main lesion is an infarction related artery (If the left main lesion is a simple left main branch lesion rather than an infarction related vessel, it is included in the study)
  6. STEMI due to Stent thrombosis
  7. A major dissection (Type C to F) occurred during the procedure including balloon dilatation for securing TIMI blood flow and the risk of acute closure at the time of staged stenting was expected

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03744000


Contacts
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Contact: Cheol Woong Yu, M.D.,Ph.D. +82-2-920-6726 ycw717@naver.com
Contact: Hyungdon Kook, M.D. +82-10-9000-8095 kookhyungdon@gmail.com

Locations
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Korea, Republic of
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of, 02841
Contact: Cheol Woong Yu, M.D., Ph.D.    +82-2-920-6726    ycw717@naver.com   
Sponsors and Collaborators
Korea University Anam Hospital
Abbott
Samjin Pharmaceutical Co., Ltd.
Investigators
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Principal Investigator: Cheol Woong Yu, M.D.,Ph.D. Cardiovascular center, Korea University Anam Hospital

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Responsible Party: Dr. Cheol Woong Yu, Professor, Korea University Anam Hospital
ClinicalTrials.gov Identifier: NCT03744000     History of Changes
Other Study ID Numbers: INNOVATION-CORE
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: November 16, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Dr. Cheol Woong Yu, Korea University Anam Hospital:
STEMI
Deferred stenting
Anterior wall myocardial infarction
Additional relevant MeSH terms:
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Myocardial Infarction
Anterior Wall Myocardial Infarction
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases