Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

ACTIVE NOT RECRUITING

NCT03744000

Deferred Stenting in Patients With Anterior Wall STEMI

Sponsor: Korea University Anam Hospital

View on ClinicalTrials.gov

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

Official title: Impact of Immediate Stent Implantation Versus Deferred Stent Implantation on Clinical Outcomes in Patients With Anterior Wall ST-segment Elevation Myocardial Infarction

Key Details

Gender

All

Age Range

19 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

185

Start Date

2018-04-03

Completion Date

2025-11-30

Last Updated

2024-04-22

Healthy Volunteers

Conditions

Acute Myocardial Infarction With ST Elevation Anterior Wall Myocardial Infarction

Interventions

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.

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.

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

Locations (1)

Korea University Anam Hospital

Seoul, South Korea