Xuanwu Hospital, Capital Medical University
Beijing, China
Location status: Recruiting
NCT Number: NCT07242768
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.
Interested in participating?
Request Info40 year–80 year
All sexes
Observational
Beijing, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
After completing 12-month intervention from RESIST trial, investigators would not make any interventions or impact on subjects.
Time frame: Within 3 years after randomization
Time frame: Within 3 years after randomization
Time frame: Within 3 years after randomization
Time frame: Within 3 years after randomization
Time frame: Within 3 years after randomization
Time frame: At 3 years after randomization
The modified Rankin scale (range, 0 [no symptoms] to 6 [death], with higher scores indicating greater disability)
Time frame: At 3 years after randomization
The score of mini-Montreal Cognitive Assessment (range, 0 to 15, with higher scores indicating greater cognition)
Time frame: 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
Time frame: Within 3 years after randomization
Time frame: Within 3 years after randomization
Contact information is provided by the study sponsor or research team.
Capital Medical University
Other
Regular Physical Exercise in Patients With Symptomatic Intracranial Arterial Stenosis: Three-year Follow-up of RESIST Trial
Acronym: RESIST-FE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06653348
Brain Diseases, Brain Ischemia
Sari, Mazandaran, Iran
View Trial DetailsNCT03710902
Arrhythmias, Cardiac, Atrial Fibrillation
Hämeenlinna, Finland
View Trial DetailsNCT04582825
Brain Diseases, Brain Ischemia
Vienna, State of Vienna, Austria
View Trial DetailsNCT05995600
Antiphospholipid Syndrome, Autoimmune Diseases
Anyang, South Korea
View Trial Details