CompREhensive Diagnostic Assessment of Coronary Endothelial Function Impairment and Vasospasm With CoNtinuous ThErmodilution in Patients With Suspected Coronary Microvascular and Vasomotor Dysfunction

Обзор

The goal of this observational study is to learn more about the diagnosis of coronary endothelium function and coronary vasospasm using a dedicated invasive protocol in patients who has angina without obstruction in their main heart arteries. The main question it aims to answer is the feasibility, reproducibility, and safety of this invasive protocol: Does this invasive protocol diagnose coronary endothelial dysfunction and vasospasm without issues? Participants already having invasive coronary angiogram and physiological studies will undergo additional physiological measurements during the same procedure. Participants will enrol in a symptoms and quality of life questionnaire using dedicated questionnaires and a mobile application to assess the burden of their symptoms before and after the invasive procedure and up to 12 months follow up. A subset of participants will undergo a repeat set of these measurements to assess reproducibility of the invasive protocol. A subset of the participants will also undergo a cardiac MRI to assess correlation with the invasive protocol measurements.

Вмешательства

• Процедура Invasive coronary physiological measurements
  Invasive assessment of changes in coronary blood flow, resistance, and distal pressure in response to acetylcholine infusion. These will be measured during a clinical indicated invasive coronary angiogram procedure and physiological studies using a standard coronary pressure wire and a dedicated infusion catheter.

Первичные конечные точки

• Feasibility outcome [Срок оценки: At baseline]

Вторичные конечные точки (5)

• Reproducibility outcome [Срок оценки: At baseline]
• Safety outcome [Срок оценки: At Baseline and up to 12 months]
• Correlation between invasive and non-invasive measures of endothelial-dependent coronary microvascular dysfunction. [Срок оценки: From baseline and up to 3 months]
• Correlation between invasive physiological indices of coronary microvascular function and symptom burden at baseline. [Срок оценки: Baseline (at time of invasive coronary function testing).]
• Change in symptoms, quality of life, and need for further investigation or treatment during follow-up. [Срок оценки: From baseline to 12 months follow-up]

Критерии участия

Критерии включения

• Patients with symptoms suggestive of angina.
• Evidence of unobstructed coronary arteries on invasive or non-invasive coronary angiography (coronary stenosis <50% and /or FFR >0.80).
• Above the age of 18.
• The subject has been informed of the nature of the study, agrees to its provisions and has signed written informed consent.

Критерии исключения

• Pregnancy.
• Contraindication to angiography and/or physiological assessment with adenosine or acetylcholine.
• Previous coronary artery bypass graft (CABG).
• Moderate to severe valvular heart disease.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07337005 · IRAS 356198

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗