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Идёт набор NCT04827498

Myocardial Ischemia Without Obstructive Coronary Stenoses

Наблюдательное Myocardial Ischemia Non-Obstructive Coronary Atherosclerosis Microvascular Coronary Artery Disease Vasospastic Angina

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: Invasive coronary endothelium-dependent and non-endothelium-dependent physiological assessment.
Кому может быть актуально
Состояния в реестре: Myocardial Ischemia, Non-Obstructive Coronary Atherosclerosis, Microvascular Coronary Artery Disease, Vasospastic Angina. 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
Испания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Myocardial Ischemia Without Obstructive Coronary Stenoses: A Prospective Observational Study With Invasive Coronary Pressure and Flow Measurements and Endothelial Function Test

Обзор

Coronary-related myocardial ischemia can result from obstructive epicardial stenosis or non-obstructive causes including coronary microcirculatory dysfunction and vasomotor disorders. This prospective study has been created in order to provide knowledge in the field of non-obstructive coronary artery disease.

Подробное описание

All-comer patients referred for coronary physiological assessment with pressure-flow measurements and acetylcholine endothelial function test, aimed to investigate different aspects of non-obstructive coronary artery disease, will be enrolled. Coronary hemodynamics during adenosine or acetylcholine evaluation will be measured either with a physiology wire equipped with pressure and temperature sensors (Abbott), or with a physiology wire equipped with pressure sensor and Doppler (Philips). Non-endothelium-dependent functional assessment will be performed with intravenous or intracoronary adenosine administration following the standard practice. Endothelium-dependent functional assessment will be performed with intracoronary acetylcholine bolus administration following the standard practice, which includes continuous 12-lead ECG monitorization. Microcirculatory dysfunction and vasomotor disorders will be diagnosed according to the criteria from the last European expert consensus on Ischaemia with Non-Obstructive Coronary Arteries (INOCA). Medical therapy will be adjusted on the basis of physiology study results and patients will be followed at 30 days, 1-, 2- and 5-years either at the outpatient clinic or by telephone contact. The Seattle Questionnaire of Angina will be applied during follow-up for obtaining an objective characterisation of the angina status.

OBJECTIVES OF THE STUDY:

* To investigate the coronary hemodynamics across the spectrum of coronary microcirculatory dysfunction. * To investigate the coronary hemodynamics across the spectrum of vasomotor disorders. * To investigate the impact of coronary microcirculatory dysfunction on clinical outcomes and patient symptoms at long-term follow-up. * To investigate the impact of coronary vasomotor disorders on clinical outcomes and patient symptoms at long-term follow-up. * To investigate the impact of a stratified medical therapy (guided by invasive physiology study) on patient symptoms. * To investigate the role of microcirculatory dysfunction and vasomotor disorders in different settings of ischemic heart disease (i.e., recurrent angina despite successful percutaneous coronary intervention; myocardial infarction without obstructive coronary artery disease; left ventricular dysfunction (either systolic or diastolic) with or without heart failure). * To develop new, alternative methods aimed to assess the coronary microcirculation. * To investigate the role of myocardial bridging on myocardial ischemia generating mechanisms. * To document safety of intracoronary testing in routine clinical practice.

Вмешательства

  • Диагностический тест Invasive coronary endothelium-dependent and non-endothelium-dependent physiological assessment
    Coronary hemodynamics and vessel anatomical measures obtained during adenosine and acetylcholine evaluation with a dedicated physiology wire

Первичные конечные точки

  • Patient-oriented composite outcome [Срок оценки: Up to 5 years]
  • Vessel-oriented composite outcome [Срок оценки: Up to 5 years]
  • Patient symptoms burden [Срок оценки: Up to 12 months]
Вторичные конечные точки (6)
  • Cumulative incidence of any death [Срок оценки: Up to 5 years]
  • Cumulative incidence of cardiac death [Срок оценки: Up to 5 years]
  • Cumulative incidence of nonfatal myocardial infarction [Срок оценки: Up to 5 years]
  • Cumulative incidence of ischemia-driven revascularization [Срок оценки: Up to 5 years]
  • Safety of invasive comprehensive coronary functional testing with adenosine and acetylcholine [Срок оценки: During procedure]
  • Emergency room visit due to angina episode [Срок оценки: Up to 5 years]

Критерии участия

Критерии включения

  • Written informed consent available.
  • Age ≥ 18 years.
  • Patient eligible for invasive physiological assessment with adenosine and / or acetylcholine.

Критерии исключения

  • Hemodynamic instability.
  • Anticipated technical issues for physiology wire measurements.
  • Culprit vessel of acute coronary syndrome
  • Contraindications for adenosine administration.
  • Contraindications for acetylcholine test.
  • Reduced life expectancy (less than 1 year).

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Испания · 1 центр
  • Hospital Clinico San Carlos — Madrid

Публикации

  • Mejia-Renteria H, Shabbir A, Nunez-Gil IJ, Macaya F, Salinas P, Tirado-Conte G, Nombela-Franco L, Jimenez-Quevedo P, Gonzalo N, Fernandez-Ortiz A, Escaned J. Feasibility and Improved Diagnostic Yield of Intracoronary Adenosine to Assess Microvascular Dysfunction With Bolus Thermodilution. J Am Heart Assoc. 2024 Nov 19;13(22):e035404. doi: 10.1161/JAHA.124.035404. Epub 2024 Nov 7. PMID 39508144
  • Mejia-Renteria H, Wang L, Chipayo-Gonzales D, van de Hoef TP, Travieso A, Espejo C, Nunez-Gil IJ, Macaya F, Gonzalo N, Escaned J. Angiography-derived assessment of coronary microcirculatory resistance in patients with suspected myocardial ischaemia and non-obstructive coronary arteries. EuroIntervention. 2023 Apr 3;18(16):e1348-e1356. doi: 10.4244/EIJ-D-22-00579. PMID 36534493

Идентификаторы

NCT: NCT04827498 · 21/289-E

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗