Идёт набор NCT07242768

Follow-up Extension Study of Regular Physical Exercise in Patients With Symptomatic Intracranial Arterial Stenosis

— Наблюдательное Ischemic Stroke Transient Ischemic Attack

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: Non-Interventional Study.
Кому может быть актуально: Состояния в реестре: Ischemic Stroke, Transient Ischemic Attack. Базовые параметры: 40 лет — 80 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: Китай
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

Regular Physical Exercise in Patients With Symptomatic Intracranial Arterial Stenosis: Three-year Follow-up of RESIST Trial

Обзор

This study will include the subjects with symptomatic intracranial arterial stenosis (ICAS) who have participated in and completed the 1-year follow-up of RESIST trial (NCT06615726). The aim is to observe the long-term clinical outcomes over 3 years after a 1-year regular physical exercise intervention in patients with symptomatic ICAS.

Подробное описание

This is a non-interventional, observational study designed to investigate long-term clinical outcomes in symptomatic ICAS patients who have already enrolled in RESIST trial and completed the 1-year follow-up.

After completing 12-month randomized intervention from RESISR trial, investigators continue to follow the subjects up to 3 years without any further intervention or changes to routine clinical management. The primary endpoint is the incidence of new ischemic stroke within 3 years. Secondary endpoints include new ischemic stroke and transient ischemic attack events in the responsible vessel supply area within 3 years; new ischemic stroke and transient ischemic attack events within 3 years; hemorrhagic stroke event within 3 years; myocardial infarction within 3 years; falls within 3 years; all-cause death within 3 years; the proportion of patients with modified Rankin Scale score 0-1 at 3 years; the score of mini-Montreal Cognitive Assessment at 3 years; and the score of EuroQol 5-Dimension 5-Level at 3 years.

Approximately 1,300 subjects who have completed the RESIST trial's 1-year follow-up and consented to continue will be included. The overall study duration will extend from the first participant's entry into the observation period until the last participant completes the 3-year follow-up.

Вмешательства

Другое Non-Interventional Study
After completing 12-month intervention from RESIST trial, investigators would not make any interventions or impact on subjects.

Первичные конечные точки

New ischemic stroke events [Срок оценки: Within 3 years after randomization]

Вторичные конечные точки (9)

New ischemic stroke and transient ischemic attack events in the responsible vessel supply area [Срок оценки: Within 3 years after randomization]
New ischemic stroke and transient ischemic attack events [Срок оценки: Within 3 years after randomization]
Hemorrhagic stroke events [Срок оценки: Within 3 years after randomization]
Myocardial infarction events [Срок оценки: Within 3 years after randomization]
Proportion of patients achieving modified Rankin Scale score (mRS) 0-1 [Срок оценки: At 3 years after randomization]
The score of mini-Montreal Cognitive Assessment [Срок оценки: At 3 years after randomization]
Quality of life assessed by EuroQol 5 Dimensions 5 level questionnaire (EQ-5D-5L) [Срок оценки: At 3 years after randomization]
Rate of Falls [Срок оценки: Within 3 years after randomization]
All-cause death [Срок оценки: Within 3 years after randomization]

Критерии участия

Критерии включения

Participants who enrolled in the RESIST trial and completed the 12-month follow-up.
Written informed consent to participate in this 3-year observational extension.