Deferred Stenting in Patients With Anterior Wall STEMI

NCT03744000 | Active Not Recruiting DMC

• 1 other identifier: INNOVATION-CORE
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 1

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. 1.the clinical efficacy and safety
2. 2.the microvascular obstruction using Cardiac magnetic resonance (MR)
3. 3.the structural and functional cardiac remodeling using conventional echocardiography and strain imaging
4. 4.the intravascular findings using optical coherence tomography (OCT)
5. 5.Clinical events A. All-cause death B. Cardiac death C. Hospitalization due to heart failure D. Recurrent MI E. TVR F. Stent thrombosis
6. 6.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

Conditions

Acute Myocardial Infarction With ST Elevation; Anterior Wall Myocardial Infarction

Keywords

STEMI; Deferred stenting; Anterior wall myocardial infarction

Outcome Measures

Primary Outcomes (1)

• composite of all-cause death, hospitalization due to heart failure, recurrent MI, TVR, major adverse cardiovascular events (MACE)

  Initial admission date to last outpatient clinic visit or clinical outcome of interest occurs, whichever occur first, assessed up to 5 years

Secondary Outcomes (9)

• All-cause death

  Initial admission date to last outpatient clinic visit or clinical outcome of interest occurs, whichever occur first, assessed up to 5 years

• Cardiac death

  Initial admission date to last outpatient clinic visit or clinical outcome of interest occurs, whichever occur first, assessed up to 5 years

• Hospitalization due to heart failure

  Initial admission date to last outpatient clinic visit or clinical outcome of interest occurs, whichever occur first, assessed up to 5 years

• Recurrent MI

  Initial admission date to last outpatient clinic visit or clinical outcome of interest occurs, whichever occur first, assessed up to 5 years

• TVR

  Initial admission date to last outpatient clinic visit or clinical outcome of interest occurs, whichever occur first, assessed up to 5 years

Study Arms (2)

Immediate 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 stenting group.

Procedure: Immediate stenting

Deferred 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 for 3-7 days in the deferred stenting group.

Procedure: Deferred stenting

Interventions

Immediate stenting PROCEDURE

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.

Immediate stenting

Deferred stenting PROCEDURE

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.

Deferred stenting

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Typical ischemic chest pain lasting more than 30 minutes
• 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.
• Symptom onset of chest pain within 6 hours
• 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.
• If TIMI blood flow before intervention is 0, 1 or 2
• If TIMI 3 blood flow was secured before coronary stenting by intracoronary abciximab injection, manual thrombus aspiration and balloon dilatation
• 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.

You may not qualify if:

• If there is a previous history of myocardial infarction or coronary artery bypass surgery
• Cardiogenic shock
• Rescue PCI after thrombolytic therapy
• 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.
• 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)
• STEMI due to Stent thrombosis
• 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

Sponsors & Collaborators

• Korea University Anam Hospital: lead
• Abbott: collaborator
• Samjin Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Anterior Wall Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Cheol Woong Yu, M.D.,Ph.D.

  Cardiovascular center, Korea University Anam Hospital

  PRINCIPAL INVESTIGATOR

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 21, 2018
• First Posted: November 16, 2018
• Study Start: April 3, 2018
• Primary Completion: April 3, 2025
• Study Completion: November 30, 2025
• Last Updated: April 22, 2024

Record last verified: 2024-04

Locations

KR (1)