RestoratIon of Myocardial Function by PeRcutaneous cOronary interVEntion in Patients With Ischemic CardioMyoPathy

Обзор

To compare the effects of physiology- and imaging-guided PCI combined with optimal medical therapy (OMT) versus OMT alone on the recovery of left ventricular systolic function in patients with ischemic cardiomyopathy and multivessel coronary artery disease.

Подробное описание

This study is a prospective, open-label, randomized, multicenter trial to test the safety and efficacy of physiology- and imaging-guided complete revascularization with PCI combined with optimal medical therapy (OMT) versus OMT alone on the recovery of left ventricle ejection fraction (LVEF) in patients with ischemic cardiomyopathy and multivessel coronary artery disease.

The primary hypothesis is that physiology- and imaging-guided complete revascularization with PCI combined with OMT will show greater improvements in LV systolic function at 6 months after randomization compared with OMT alone.

Patients with left ventricular ejection fraction (LVEF) less than 40% on echocardiography will undergo gadolinium-enhanced cardiac MRI to determine the underlying cause of cardiac dysfunction and assess the presence of viable myocardium. Among patients suspected of having ischemic cardiomyopathy, those who provide informed consent will be considered for enrollment. Eligible patients undergoing invasive coronary angiography and meeting inclusion and exclusion criteria will be randomly assigned to either: a group receiving physiology- and imaging-guided PCI in combination with optimal medical therapy, or a group receiving optimal medical therapy alone.

Improvement in LVEF will be evaluated using follow-up gadolinium-enhanced cardiac MRI at 6 months. Clinical outcomes will be assessed at 6 and 12 months, and long-term outcomes will be analyzed through 36-month follow-up.

Вмешательства

• Процедура Physiology-and imaging-guided PCI
  The criteria for performing revascularization are as follows 1. Lesions with ≥50% diameter stenosis and FFR ≤ 0.80, or lesions with severe stenosis (\>90%) 2. In vessels meeting the above criteria, IVUS findings consistent with either: * Minimum lumen area (MLA) ≤ 3 mm² * 3 mm² \< MLA ≤ 4 mm² and plaque burden \>70% For all target vessels and lesions identified for intervention, optimal revascularization should be pursued. The criteria for optimal revascularization are as follows, and o
• Препарат Optimal medical treatment
  All study participants will receive guideline-directed medical therapy. Even for patients assigned to the optimal medical therapy group, revascularization may be performed during follow-up if clinically indicated. If such a decision is made prior to the primary endpoint assessment, a gadolinium-enhanced cardiac MRI will be performed at the time of consideration to reassess myocardial viability.

Первичные конечные точки

• LV ejection fraction from GE-MRI [Срок оценки: At 6 months after randomization]

Вторичные конечные точки (12)

• Changes in the transmural extent of myocardial infarction from GE-MRI [Срок оценки: At 6 months after randomization]
• Number of improved dysfunctional myocardial segments from GE-MRI [Срок оценки: At 6 months after randomization]
• Changes in the LV chamber size from GE MRI [Срок оценки: At 6 months after randomization]
• LV ejection fraction from echocardiography [Срок оценки: At 6 months and 12 months after randomization]
• Number of improved dysfunctional myocardial segments from echocardiography [Срок оценки: At 6 months and 12 months after randomization]
• Changes in the LV chamber size change from echocardiography [Срок оценки: At 6 months and 12 months after randomization]
• All-cause death [Срок оценки: At 6 months, 12 months, and 36 months after randomization]
• Cardiovascular death [Срок оценки: At 6 months, 12 months, and 36 months after randomization]
• Non-fatal myocardial infarction [Срок оценки: At 6 months, 12 months, and 36 months after randomization]
• Unplanned revascularization [Срок оценки: At 6 months, 12 months, and 36 months after randomization]
• Hospitalization for heart failure [Срок оценки: At 6 months, 12 months, and 36 months after randomization]
• EuroQol 5-Dimension 5-Level Questionnaire [Срок оценки: At 6 months, 12 months, and 36 months after randomization]

Критерии участия

Критерии включения

• Subject must be ≥ 19 years
• Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive physiologic or imaging evaluation and PCI and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
• Subject with LV ejection fraction <40% from cardiac MRI
• Subject with multivessel disease in major epicardial coronary artery disease or their major branches (vessel size of 2.5 mm or more than 2.5mm) considering coronary revascularization

Критерии исключения

• Subjects with more than 50% transmural extent of infarction on GE-MRI in more than 25% of the dysfunctional myocardial segments
• Subject with suspicious of other cardiomyopathy (dilated cardiomyopathy, hypertrophic cardiomyopathy etc.)
• Subject with recent myocardial infarction within 4 weeks
• Subject with recent fatal arrhythmia (VT or VF) within 4 weeks
• Subject with hemodynamically unstable state
• Subject with complex coronary artery lesions, such as chronic total occlusions, in which complete revascularization is considered unfeasible
• Subject for whom coronary artery bypass surgery is prioritized over coronary artery intervention
• Subject with severe valvular heart disease requiring open heart surgery
• Subject with history of coronary artery bypass surgery or valve surgery
• Subject with expected life expectancy of less than 1 year
• Subject considered ineligible for this study based on the investigator's discretion

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

South Korea · 1 центр

• Seoul National University Hospital — Seoul

Идентификаторы

NCT: NCT06930092 · H-2411-106-1590 · Not yet assigned · Not yet assigned

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗