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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regular Physical Exercise Group | Participants with symptomatic ICAS who were assigned to the regular physical exercise intervention in the RESIST trial and completed the 12-month follow-up. |
| |
| Control Group | Participants with symptomatic ICAS who were assigned to the control group in the RESIST trial and completed the 12-month follow-up. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional Study | Other | After completing 12-month intervention from RESIST trial, investigators would not make any interventions or impact on subjects. |
|
| Measure | Description | Time Frame |
|---|---|---|
| New ischemic stroke events | Within 3 years after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| New ischemic stroke and transient ischemic attack events in the responsible vessel supply area | Within 3 years after randomization | |
| New ischemic stroke and transient ischemic attack events | Within 3 years after randomization |
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Inclusion Criteria:
Exclusion Criteria:
Participants who withdrew consent in the RESIST trial, decline to participate in this extension, or were lost to follow-up at 12 months.
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This study will include the subjects who enrolled in the RESIST trial.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xunming Ji | Contact | 01083198962 | jixm@ccmu.edu.cn | |
| Chuanjie Wu | Contact | 01083199439 | wuchuanjie@ccmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital, Capital Medical University | Recruiting | Beijing | China |
The study is proceeding.
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D002546 | Ischemic Attack, Transient |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Hemorrhagic stroke events | Within 3 years after randomization |
| Myocardial infarction events | Within 3 years after randomization |
| Proportion of patients achieving modified Rankin Scale score (mRS) 0-1 | The modified Rankin scale (range, 0 [no symptoms] to 6 [death], with higher scores indicating greater disability) | At 3 years after randomization |
| The score of mini-Montreal Cognitive Assessment | The score of mini-Montreal Cognitive Assessment (range, 0 to 15, with higher scores indicating greater cognition) | At 3 years after randomization |
| Quality of life assessed by EuroQol 5 Dimensions 5 level questionnaire (EQ-5D-5L) | The EQ-5D-5L includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= n | At 3 years after randomization |
| Rate of Falls | Within 3 years after randomization |
| All-cause death | Within 3 years after randomization |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002545 | Brain Ischemia |