Aneurysm, RupturedPhase 2/3NEAT-2NCT03561311
The Neuroprotective Effect of Remote Ischemic Conditioning in Ruptured Aneurysm Coiling Therapy
A Phase 2/3 study testing remote ischemic conditioning in people with Aneurysm, Ruptured and Coiling Therapy, run by Capital Medical University at 5 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysm, Ruptured, Coiling Therapy
- What is being tested?
- remote ischemic conditioning
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 5 sitesChina
- Study dates
- 6 Oct 2018to 30 Jun 2019
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Ruptured brain aneurysm deemed suitable for neuroendovascular repair
- Normal baseline brain MRI
- Female subjects of childbearing potential have a negative pregnancy test.
- Signed informed consent prior to entering study
Who cannot join
- Dissecting or mycotic brain aneurysm.
- Planned endovascular vessel sacrifice as the primary modality for aneurysm treatment
- Renal insufficiency with creatinine ≥ 265 umol/L
- Severe, sustained hypertension (SBP > 185 mmHg or DBP > 110 mmHg)
- Contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs
- Pre-morbid modified Rankin scale score of greater than 1
- Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations Patients who are unable to have an MRI scan for any reason.
- Currently participating or previously participated in any investigational drug or device study within 6 months.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites, 5 recruiting
- Not yet recruiting
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
Xunming Ji
Xunming Ji
- Recruiting
Shengli Oilfield Central Hospital
Dongying, Shandong
Zongen Gao
Zongen Gao
- Recruiting
The Second People's Hospital of Liaocheng
Liaocheng
Wansheng Chang
- Recruiting
Nanyang City Center Hospital
Nanyang
Changming Wen
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
Yajun Lian
About this study
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.
- Conditions
- Aneurysm, Ruptured, Coiling Therapy
- Being tested
- remote ischemic conditioning, sham remote ischemic conditioning
- Medical subject headings
- Aneurysm, Ruptured
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remote ischemic conditioningDevice
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 conditioningDevice
Sham remote ischemic conditioning is performed by using an electric autocontrol device with cuffs that inflated to a pressure of 60 mm Hg
| Study group | Role | What they receive |
|---|---|---|
| Remote ischemic conditioning group | Experimental | Not described Receives: Device: remote ischemic conditioning |
| Sham remote ischemic conditioning group | Sham comparator | Not described Receives: Device: sham remote ischemic conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
The presence of ≥1 new brain lesions on DWI
Assessed by DWI
Measured: within 72 hours after endovascular treatment
Secondary outcomes (6)
Number of new ischemic lesions
Measured: within 72 hours after endovascular treatment
Volume of new ischemic lesions
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30 days
Modified Rankin Scale
Scores on the modified Rankin scale of functional disability range from 0 (no symptoms) to 6 (death).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start6 Oct 2018
- Primary completion31 May 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneurysm, RupturedStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Xunming,MD,PhD, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03561311
- Sponsor's protocol ID
- 2017-NEAT-2
- Acronym
- NEAT-2
- Status last verified
- Nov 2018
- First submitted
- 23 May 2018
- Last updated
- 23 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Neuroprotective Effect of Remote Ischemic Conditioning in Ruptured Aneurysm Coiling Therapy
- ClinicalTrials.gov ID
- NCT03561311
- Acronym / sponsor ID
- NEAT-2 / 2017-NEAT-2
- Conditions
- Aneurysm, Ruptured, Coiling Therapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 6 Oct 2018 (actual)
- Primary completion
- 31 May 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 19 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote ischemic conditioning group | Experimental | Device: remote ischemic conditioning |
| Sham remote ischemic conditioning group | Sham comparator | Device: sham remote ischemic conditioning |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older
- Ruptured brain aneurysm deemed suitable for neuroendovascular repair
- Normal baseline brain MRI
- Female subjects of childbearing potential have a negative pregnancy test.
- Signed informed consent prior to entering study
Key exclusion criteria (8 listed)
- Dissecting or mycotic brain aneurysm.
- Planned endovascular vessel sacrifice as the primary modality for aneurysm treatment
- Renal insufficiency with creatinine ≥ 265 umol/L
- Severe, sustained hypertension (SBP > 185 mmHg or DBP > 110 mmHg)
- Contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| remote ischemic conditioningRemote 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) | Device | Remote ischemic conditioning group |
| sham remote ischemic conditioningSham remote ischemic conditioning is performed by using an electric autocontrol device with cuffs that inflated to a pressure of 60 mm Hg | Device | Sham remote ischemic conditioning group |
Primary outcome
The presence of ≥1 new brain lesions on DWI
Time frame: within 72 hours after endovascular treatment
Assessed by DWI
6 secondary outcomes
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
Time frame: 7 days or discharge
Composite of Cerebrovascular events
Time frame: 30 days
Nondisabling events
Time frame: 30 days
Modified Rankin Scale
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing remote ischemic conditioning in people with Aneurysm, Ruptured and Coiling Therapy, run by Capital Medical University at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xunming Ji, MD (008601083198930, jixm@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The presence of ≥1 new brain lesions on DWI (time frame: within 72 hours after endovascular treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2018.