A Phase 2/3 interventional study of remote ischemic conditioning and sham remote ischemic conditioning in Aneurysm, Ruptured and Coiling Therapy, sponsored by Capital Medical University. Status unknown at 5 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-23.
Sponsored by Capital Medical University · Phase 2/3, Interventional, and Treatment
The overall incidence of DWI positive for thromboembolic events following endovascular treatment of intracranial aneurysms is proximately 50%. Whether remote ischemic conditioning was safe and effective to reduce ischemic brain lesions on DWI after endovascular treatment of intracranial aneurysms is still unclear. The investigators' hypothesis is that remote ischemic conditioning is a safe and effective strategy to reduce new ischemic lesions in intracranial aneurysms patients undergoing endovascular treatment.
29 studies on the registry are indexed under Aneurysm, Ruptured; 7 are open to participants now.
This study's planned enrollment of 210 is above the median of 33 across 16 interventional studies indexed under Aneurysm, Ruptured.
Browse Aneurysm, Ruptured studies →Capital Medical University is the lead sponsor of 295 studies on the registry; 91 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: remote ischemic conditioning
Device: sham remote ischemic conditioning
Remote ischemic conditioning is performed by using an electric autocontrol device with cuffs that inflated to a pressure of 200 mm Hg during the ischemic period (Patent No. CN200820123637.X, China)
Sham remote ischemic conditioning is performed by using an electric autocontrol device with cuffs that inflated to a pressure of 60 mm Hg
The presence of ≥1 new brain lesions on DWI
Assessed by DWI
Time frame: within 72 hours after endovascular treatment
Number of new ischemic lesions
Time frame: within 72 hours after endovascular treatment
Volume of new ischemic lesions
Time frame: within 72 hours after endovascular treatment
National Institutes of Health Stroke Scale
Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating more severe neurologic deficits.
Time frame: 7 days or discharge
Composite of Cerebrovascular events
This is a composited endpoint.Cerebrovascular events included ischemic stroke, hemorrhagic stroke, and TIA. The present subarachnoid hemorrhage isn't included.
Time frame: 30 days
Nondisabling events
Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating more severe neurologic deficits.National Institutes of Health Stroke Scale ≤3 or TIA is defined as nondisabling events The present subarachnoid hemorrhage isn't included.
Time frame: 30 days
Modified Rankin Scale
Scores on the modified Rankin scale of functional disability range from 0 (no symptoms) to 6 (death).
Time frame: 30 days
Occurrence of adverse events and serious adverse events
Occurrence of adverse events and serious adverse events
Time frame: 30 days
Started Oct 2018 (actual). Primary completion is estimated for May 2019, 7 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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