UnknownNot Applicable

Deferred Stenting in Patients With Anterior Wall STEMI

South Korea185 participantsStarted 2018-04-03

Plain-language 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

Who can participate

Age range19 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

What they're measuring

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

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

Trial details

NCT IDNCT03744000

SponsorKorea University Anam Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-03

View on ClinicalTrials.gov More Acute Myocardial Infarction With ST Elevation trials

Plain-language summary

Who can participate

Age range19 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Deferred Stenting in Patients With Anterior Wall STEMI

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Deferred Stenting in Patients With Anterior Wall STEMI

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Exclusion criteria