Ischemic Stroke, Transient Ischemic Attack
Conditions
Keywords
Ischemic Stroke, Transient Ischemic Attack, Symptomatic intracranial arterial stenosis
Brief summary
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.
Detailed description
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.
Interventions
OTHERNon-Interventional Study
After completing 12-month intervention from RESIST trial, investigators would not make any interventions or impact on subjects.
Sponsors
Capital Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Participants who enrolled in the RESIST trial and completed the 12-month follow-up. 2. Written informed consent to participate in this 3-year observational extension.
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| New ischemic stroke events | Within 3 years after randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | At 3 years after randomization | The modified Rankin scale (range, 0 \[no symptoms\] to 6 \[death\], with higher scores indicating greater disability) |
| The score of mini-Montreal Cognitive Assessment | At 3 years after randomization | The score of mini-Montreal Cognitive Assessment (range, 0 to 15, with higher scores indicating greater cognition) |
| Quality of life assessed by EuroQol 5 Dimensions 5 level questionnaire (EQ-5D-5L) | At 3 years after randomization | The EQ-5D-5L includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= n |
| Rate of Falls | Within 3 years after randomization | — |
| All-cause death | Within 3 years after randomization | — |
Countries
China
Contacts
CONTACTXunming Ji
CONTACTChuanjie Wu
Outcome results
None listed