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Набор по приглашению NCT07722793

EndoVascular Aneurysm Repair: Heart Remodeling and Aortic Stiffness Study

— Наблюдательное Abdominal Aortic Aneurysm Arterial Stiffness Left Ventricle Remodeling

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Abdominal Aortic Aneurysm, Arterial Stiffness, Left Ventricle Remodeling. 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
Хорватия
Следующий шаг
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Официальное название

Impact of Endovascular Abdominal Aortic Aneurysm Repair on Aortic Stiffness and Left Ventricular Remodeling

Обзор

Abdominal aortic aneurysm (AAA) is associated with a high burden of cardiovascular morbidity and mortality. Although endovascular aneurysm repair (EVAR) has become the preferred treatment for many patients with infrarenal AAA because of its lower perioperative risk, its impact on arterial stiffness and cardiac function remains insufficiently understood. Experimental and clinical evidence suggests that endograft implantation may increase aortic stiffness by reducing aortic compliance, potentially altering ventricular-arterial coupling and contributing to left ventricular remodeling and dysfunction. This prospective observational study aims to evaluate the effects of elective EVAR on aortic stiffness, left ventricular structure and function, and circulating biomarkers of myocardial stress and extracellular matrix remodeling. Patients with infrarenal AAA scheduled for elective EVAR will be assessed before the procedure and at 48 hours, 6 months, and 12 months after intervention. Aortic stiffness will be assessed using estimated carotid-femoral pulse wave velocity (cfPWV), while left ventricular function and remodeling will be evaluated by transthoracic echocardiography, including global longitudinal strain (GLS). Circulating NT-proBNP and MMP-3 concentrations will also be measured. The study will provide insight into the cardiovascular effects of EVAR and may improve understanding of procedure-related changes in arterial stiffness and cardiac remodeling, thereby supporting better long-term cardiovascular risk assessment and postoperative management in patients undergoing EVAR.

Первичные конечные точки

  • Change in arterial stiffness after endovascular aneurysm repair (EVAR) [Срок оценки: Baseline (pre-EVAR) to 12 months after EVAR (2 days, 6 months, 12 months)]
Вторичные конечные точки (8)
  • Early and long-term changes in arterial stiffness after EVAR [Срок оценки: Baseline, 2 days, 6 months, 12 months]
  • Change in left ventricular ejection fraction (LVEF) [Срок оценки: Baseline, 2 days, 6 months, 12 months]
  • Changes in circulating biomarkers after EVAR [Срок оценки: Baseline, 2 days, 6 months, 12 months]
  • Change in left ventricular filling pressure (E/e') [Срок оценки: Baseline, 2 days, 6 months, 12 months]
  • Change in left atrial volume index (LAVI) [Срок оценки: Baseline, 2 days, 6 months, 12 months]
  • Change in left ventricular end-diastolic volume (LVEDV) [Срок оценки: Baseline, 2 days, 6 months, 12 months]
  • Change in left ventricular global longitudinal strain (LV GLS) [Срок оценки: Baseline, 2 days, 6 months, 12 months]
  • Change in left atrial reservoir strain (LA reservoir strain) [Срок оценки: Baseline, 2 days, 6 months, 12 months]

Критерии участия

Критерии включения

  • Adult patients (≥18 years of age) with diagnosed abdominal aortic aneurysm (AAA) who are scheduled for elective endovascular aneurysm repair (EVAR)
  • Patients eligible for EVAR according to current clinical guidelines and anatomical criteria
  • Signed informed consent for participation in the study
  • Ability to undergo scheduled follow-up examinations (baseline, early post-procedural assessment, and follow-up visits)

Критерии исключения

  • Emergency EVAR for ruptured or symptomatic abdominal aortic aneurysm
  • Previous aortic repair or previous endovascular intervention involving the abdominal aorta
  • Concomitant major cardiovascular surgery or intervention during the study period
  • Severe hemodynamic instability or critical illness at the time of inclusion
  • Active infection or acute inflammatory disease that may influence vascular or inflammatory biomarkers
  • Malignancy with active treatment or life expectancy limiting follow-up
  • Inability to provide informed consent
  • Inability to complete planned follow-up assessments
  • Known severe valvular heart disease or advanced heart failure
  • Conditions affecting arterial stiffness measurements (e.g. atrial fibrillation, severe arrhythmias, inability to obtain reliable PWV measurements)

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Хорватия · 1 центр
  • Department of Vascular Surgery, University Hospital Center Osijek — Osijek

Идентификаторы

NCT: NCT07722793 · EVAR-HRAS Study

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗