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Идёт набор NCT07133984

STICH3C Cardiac Magnetic Resonance Observational Study

— Наблюдательное Ischemic Left Ventricle Systolic Dysfunction Multivessel Coronary Artery Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Cardiac Magnetic Resonance Imaging.
Кому может быть актуально
Состояния в реестре: Ischemic Left Ventricle Systolic Dysfunction, Multivessel Coronary Artery Disease. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США, Австрия, Канада, Китай, Сербия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

STICH3C Cardiac Magnetic Resonance (CMR) Observational Study (STICOS)

Обзор

STICOS will test the hypothesis that residual jeopardized myocardium, late gadolinium enhancement, and non-ischemic substrate after revascularization is associated with postoperative adverse cardiovascular events such as heart failure , readmission, or death. This study will look at whether certain heart tissue abnormalities seen on MRI scans can help predict serious health problems after heart procedures like stents or bypass surgery.

Подробное описание

iLVSD (ischemic left ventricular dysfunction) is a leading cause of heart failure (HF) and death. It is widely treated via coronary revascularization despite limited understanding of determinants of revascularization response.

"Viability" imaging (to differentiate infarcted from salvageable myocardium) has been widely touted as an effective means to predict revascularization response. However prior multicenter trials have derived negative conclusions using heterogenous data with respect to both image modality and analysis.

Data by our investigators and others indicate that infarct transmurality on CMR strongly impacts remodeling and prognosis after coronary revascularization. The investigators have also developed new methods (dark-blood late gadolinium enhancement-CMR) to assess infarction and shown ischemia (hypoperfusion) and non-ischemic substrate on CMR to strongly impact LV remodeling. Despite conceptual rationale, utility of multiparametric CMR to elucidate mechanism and determinants of remodeling and differential outcomes after percutaneous and surgical revascularization of iLVSD has yet to be tested.

This prospective study will test the hypothesis that residual jeopardized (viable but hypoperfused) myocardium, LGE, and non-ischemic substrate after coronary revascularization (by PCI or CABG) is associated with postoperative adverse cardiovascular events

Вмешательства

  • Диагностический тест Cardiac Magnetic Resonance Imaging
    Cardiac MRI, also known as cardiac magnetic resonance imaging, is a non-invasive imaging technique that uses strong magnetic fields and radio waves to produce detailed pictures of the heart and its surrounding structures

Первичные конечные точки

  • Cardiac Magnetic Resonance Imaging (CMR) Indices [Срок оценки: 5 years]

Критерии участия

Критерии включения

  • Men and women ≥ 18 years old
  • LVEF ≤ 40% (quantified by echo, single-photon emission computed tomography \[SPECT\], or CMR within 2 months of enrollment)
  • Prognostically important CAD: either multivessel CAD (triple vessel or double vessel CAD including left anterior descendant artery (LAD), significant coronary stenosis defined as ≥ 70% based on coronary angiography, fractional flow reserve (FFR) ≤ 0.80 or instantaneous wave-free ratio (iFR) ≤ 0.89) or left main disease (+/- other CAD) for which significant stenosis defined as > 50% based on coronary angiography, intravascular ultrasound (IVUS) minimum luminal area \[MLA\] value ≤ 6.0 mm2 (< 4.5 mm2 Asian descent), or equivalent optical coherence tomography (OCT) measurements.
  • Planned CABG or PCI within 3 months

Критерии исключения

  • Concomitant valve disease or other condition (e.g., LV aneurysm) requiring surgical repair or replacement
  • Contraindication to CMR (i.e. magnetically activated materials), gadolinium, regadenoson/adenosine/dipyridamole
  • Active neoplasm and/or severe end-organ dysfunction with expected life expectancy less than 5 years.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 3 центра
  • NewYork-Presbyterian Brooklyn Methodist Hospital — Brooklyn
  • New York Presbyterian - Queens — Flushing
  • Weill Cornell Medicine/NewYork Presbyterian Hospital — New York
Канада · 3 центра
  • Libin Cardiovascular Institute — Calgary
  • Universite Laval Quebec (CRIUCPQ) Canada — Québec
  • Sunnybrook Health Sciences Centre — Toronto
Австрия · 1 центр
  • MU Vienna Austria — Vienna
Китай · 1 центр
  • Ruijin Hospital Shanghai Jiao Tong University School of Medicine — Шанхай
Сербия · 1 центр
  • Dedinje Cardiovascular Institute — Belgrade

Идентификаторы

NCT: NCT07133984 · 23-09026465 · 1R01HL170566-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗