Идёт набор NCT06424834

Efficacy of Targeted Medical Therapy in Angina and Nonobstructive Coronary Arteries

Фаза II / Фаза III С лечением Angina Pectoris Microvascular Angina Vasospastic Angina Myocardial Bridge of Coronary Artery

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: Amlodipine, Nebivolol, Placebo.
Кому может быть актуально: Состояния в реестре: Angina Pectoris, Microvascular Angina, Vasospastic Angina, Myocardial Bridge of Coronary Artery. 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
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

A Randomized Controlled Study of Targeted Medical Therapy Versus Placebo for Angina and Non- Obstructive Coronary Arteries: The MVP-ANOCA Study

Обзор

The goal of this clinical trial is to learn if targeted medical therapy will improve symptoms and quality of life in patients with angina and non-obstructive coronary arteries compared to placebo, after the underlying cause of the chest pain has been ascertained by coronary function testing. Participants will be treated with either medications that target the underlying cause of their chest pain or placebo for 4 weeks after a drug titration phase of 1-3 weeks. They will be asked to complete a series of questionnaires to evaluate their quality of life at the beginning and end of the study.

Вмешательства

Препарат Amlodipine
Amlodipine taken once orally daily at a starting dose of 2.5mg, uptitrated to a maximum of 10mg if tolerated.
Препарат Nebivolol
Nebivolol taken once orally daily at a starting dose of 5mg, uptitrated to a maximum of 20mg if tolerated.
Препарат Placebo
Placebo taken once orally daily.

Первичные конечные точки

Seattle Angina Questionnaire summary score [Срок оценки: 5-7 weeks (depending on drug titration period)]

Вторичные конечные точки (12)

EuroQol 5 dimension - 5L index score [Срок оценки: 5-7 weeks (depending on drug titration period)]
EuroQol 5 dimension - 5L visual analogue score [Срок оценки: 5-7 weeks (depending on drug titration period)]
PHQ-4 score [Срок оценки: 5-7 weeks (depending on drug titration period)]
Treatment Satisfaction Questionnaire for Medication score [Срок оценки: 5-7 weeks (depending on drug titration period)]
Seattle Angina Questionnaire summary score stratified by specific chest pain endotypes [Срок оценки: 5-7 weeks (depending on drug titration period)]
EuroQol 5 dimension - 5L index score stratified by specific chest pain endotypes [Срок оценки: 5-7 weeks (depending on drug titration period)]
EuroQol 5 dimensions - 5L visual analogue score stratified by specific chest pain endotypes [Срок оценки: 5-7 weeks (depending on drug titration period)]
PHQ-4 scores stratified by specific chest pain endotypes [Срок оценки: 5-7 weeks (depending on drug titration period)]
Treatment Satisfaction Questionnaire for Medication score stratified by specific chest pain endotypes [Срок оценки: 5-7 weeks (depending on drug titration period)]
Seattle Angina Questionnaire summary score stratified by baseline angina frequency [Срок оценки: 5-7 weeks (depending on drug titration period)]
Proportion of patients with good response, no angina, and excellent health status [Срок оценки: 5-7 weeks (depending on drug titration period)]
Safety endpoints [Срок оценки: Baseline]

Критерии участия

Критерии включения

All patients with stable angina referred to the Stanford University Hospital cardiac catheterization laboratory for clinically indicated coronary function testing are eligible for inclusion into the study.

Specific inclusion criteria for randomization:

Absence of significant epicardial coronary artery disease on angiography
Fractional flow reserve > 0.80

And ≥ 1 of the following:

Epicardial coronary spasm on acetylcholine testing
Microvascular spasm on acetylcholine testing
Coronary flow reserve < 2.5
Index of microcirculatory resistance ≥ 25
Myocardial bridge on intravascular ultrasound with dobutamine resting full-cycle ratio ≤ 0.76