Acute StrokePhase 2REVISE-2NCT03045055
Remote Ischemic Conditioning Paired With Endovascular Treatment for Acute Ischemic Stroke
A Phase 2 study testing Remote ischemic conditioning. and Endovascular treatment. in people with Acute Stroke, run by Capital Medical University.
Trial summary
Ischemic stroke, which is due to the occlusion of a cerebral blood vessel, comprises nearly 80-90% of all strokes. Currently, reperfusion of the salvageable tissue via thrombolytic drug or endovascular treatment is the most effective strategy to reduce brain damage. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Stroke
- What is being tested?
- Remote ischemic conditioning. and Endovascular treatment.
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2020to 31 Mar 2023
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute ischemic stroke where patient is ineligible for intravenous thrombolytic treatment or the treatment is contraindicated, or where patient has received intravenous thrombolytic therapy without recanalization;
- Suspected proximal anterior circulation occlusion;
- No remarkable pre-stroke functional disability (mRS ≤ 1);
- Baseline NIHSS score obtained prior to randomization must be ≥6;
- Age ≥18 and ≤ 80;
- Patient treatable within 24 hours of symptom onset;
- Informed consent obtained from patient or acceptable patient's surrogate
Who cannot join
- Identified hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR > 3.0;
- Baseline platelet count < 30*109/L;
- Baseline blood glucose of < 2.7mmol/L or >22.2mmol/L;
- Renal insufficiency with creatinine ≥ 265 umol/L;
- Severe, sustained hypertension (SBP > 185 mmHg or DBP > 110 mmHg);
- Rapidly improving symptoms at the discretion of the investigator;
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- Seizures at stroke onset which would preclude obtaining a baseline NIHSS;
- Serious, advanced, or terminal illness with anticipated life expectancy of less than one year;
- History of life threatening allergy to contrast medium, Nickel, Titanium metals or their alloys;
- Woman of childbearing potential who is known to be pregnant or lactating or who has a positive pregnancy test on admission;
- Subject participating in a study involving other drug or device trial study;
- Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations;
- Unlikely to be available for 90-day follow-up;
- Contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs;
- Hypodensity on CT or restricted diffusion amounting to an ASPECTS score of <7 on noncontrast CT or <6 on DWI MRI;
- CT or MRI evidence of hemorrhage;
- Significant mass effect with midline shift on CT or MRI scans;
- Angiogram shows arterial tortuosity, pre-existing stent, and/or other arterial disease, which would prevent the device from reaching the target vessel and/or preclude safe recovery of the device;
- Subjects with artery occlusions in multiple vascular territories;
- Evidence of intracranial tumor.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Proof-of-Concept Study Assessing the Safety and Efficacy of Remote Ischemic Conditioning for Acute Ischemic Stroke Patients Undergoing Endovascular Treatment
Ischemic stroke, which is due to the occlusion of a cerebral blood vessel, comprises nearly 80-90% of all strokes. Currently, reperfusion of the salvageable tissue via thrombolytic drug or endovascular treatment is the most effective strategy to reduce brain damage. However, after recanalizing the occluded vessels, subsequent reperfusion injury is inevitable. It may not only weaken the therapeutic effects of timely reperfusion but also impede patients' recovery. Moreover, thousands of neuroprotective drugs effective in experimental models have been proved to be unsuccessful in clinical trials. Therefore, effective strategies are urgently needed to prevent and treat cerebral reperfusion injury and further improve the prognosis of acute ischemic stroke.
Researchers applied remote ischemic conditioning to mouse model of focal cerebral reperfusion injury and found that it could reduce cerebral infarct size. And clinical researches demonstrated that remote ischemic conditioning was an effective strategy to improve cerebral perfusion and prevent recurrent stroke in patients with ischemic stroke. However, whether remote ischemic conditioning is safe and effective in protecting patients with large-vessel ischemic stroke and undergoing endovascular treatment is still unclear. The investigators' hypothesis is that RIC is a safe and effective strategy to reduce brain injuries in stroke patients undergoing endovascular treatment.
- Conditions
- Acute Stroke
- Being tested
- Remote ischemic conditioning., Endovascular treatment., Sham remote ischemic conditioning
- Keywords
- Acute ischemic stroke, Endovascular treatment, Remote ischemic conditioning
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic conditioning.Device
Also called RIC
The RIC procedure consists of four cycles of unilateral arm ischemia for 5 minutes, which was followed by reperfusion for another 5 minutes. The procedure is performed with an electric, autocontrol device with a cuff that inflated to a pressure of 200 mmHg during the ischemia period. RIC is performed before recanalization of the occluded artery, immediately following successful recanalization, and once daily for the subsequent 7 days.
Endovascular treatment.Procedure or surgery
Endovascular treatment of acute ischemic stroke is performed by experienced neuroradiologist according to the latest guideline from American Heart Association and American Stroke Association.It includes thrombectomy, intra-arterial thrombolysis, thrombus aspiration, stenting and balloon angioplasty.
Sham remote ischemic conditioningDevice
Also called Sham RIC
The sham RIC procedure consists of four cycles of unilateral arm ischemia for 5 minutes, which was followed by reperfusion for another 5 minutes. The procedure is performed with an electric, autocontrol device with a cuff that inflated to a pressure of 30 mmHg during the ischemia period. Sham RIC is performed before recanalization of the occluded artery, immediately following successful recanalization, and once daily for the subsequent 7 days.
| Study group | Role | What they receive |
|---|---|---|
| RIC group | Experimental | RIC (remote ischemic conditioning) paired with endovascular treatment. Receives: Device: Remote ischemic conditioning.; Procedure: Endovascular treatment. |
| Sham group | Sham comparator | Sham RIC (remote ischemic conditioning) paired with endovascular treatment. Receives: Procedure: Endovascular treatment.; Device: Sham remote ischemic conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral infarction volume.
The cerebral infarction volume is evaluated on cerebral imaging.
Measured: 7 days after stroke onset.
Secondary outcomes (5)
The proportion of enrolled subjects that completed all the designed RIC procedures.
Nine times of RIC or sham RIC interventions are planned to be applied to each subject pre and post-endovascular treatment.
Measured: 0-7 days.
The severity of global disability at 90 days, as assessed by modified Rankin scale (mRS).
The mRS is an ordinal, graded interval scale that assigns patients among 7 global disability levels, which ranging from 0 (no symptom) to 5 (severe disability) and 6 (death).
Measured: 0-90 days.
Change in NIHSS.
NIHSS will be assessed by certified study investigator who are blind to the treatment assignment at baseline (pre-operation), 24±6 hrs, 5 to 7 days or discharge if earlier, and 90±7 days post-recanalization.
Measured: 0-90 days.
Symptomatic Intracerebral Hemorrhage.
Deterioration in NIHSS score of ≥4 points within 24 hours from treatment and evidence of intraparenchymal hemorrhage type 2 in imaging scans.
Measured: 0-90 days.
Safety - Assessment of adverse events and serious adverse events.
Assessment of adverse events and serious adverse events.
Measured: 0-90 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2017 (estimated)
- Study start1 Aug 2020 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute StrokeStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Shengli Oilfield Hospital
- Responsible party
- Principal investigator, Ji Xunming,MD,PhD, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03045055
- Sponsor's protocol ID
- REVISE-2
- Acronym
- REVISE-2
- Status last verified
- Jul 2020
- First submitted
- 3 Feb 2017
- Last updated
- 27 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Hausenloy DJ, Barrabes JA, Botker HE, Davidson SM, Di Lisa F, Downey J, Engstrom T, Ferdinandy P, Carbrera-Fuentes HA, Heusch G, Ibanez B, Iliodromitis EK, Inserte J, Jennings R, Kalia N, Kharbanda R, Lecour S, Marber M, Miura T, Ovize M, Perez-Pinzon MA, Piper HM, Przyklenk K, Schmidt MR, Redington A, Ruiz-Meana M, Vilahur G, Vinten-Johansen J, Yellon DM, Garcia-Dorado D. Ischaemic conditioning and targeting reperfusion injury: a 30 year voyage of discovery. Basic Res Cardiol. 2016 Nov;111(6):70. doi: 10.1007/s00395-016-0588-8. Epub 2016 Oct 20.
PubMed 27766474Zhao W, Meng R, Ma C, Hou B, Jiao L, Zhu F, Wu W, Shi J, Duan Y, Zhang R, Zhang J, Sun Y, Zhang H, Ling F, Wang Y, Feng W, Ding Y, Ovbiagele B, Ji X. Safety and Efficacy of Remote Ischemic Preconditioning in Patients With Severe Carotid Artery Stenosis Before Carotid Artery Stenting: A Proof-of-Concept, Randomized Controlled Trial. Circulation. 2017 Apr 4;135(14):1325-1335. doi: 10.1161/CIRCULATIONAHA.116.024807. Epub 2017 Feb 7.
PubMed 28174194Zhao W, Che R, Li S, Ren C, Li C, Wu C, Lu H, Chen J, Duan J, Meng R, Ji X. Remote ischemic conditioning for acute stroke patients treated with thrombectomy. Ann Clin Transl Neurol. 2018 Jun 6;5(7):850-856. doi: 10.1002/acn3.588. eCollection 2018 Jul.
PubMed 30009202Zhao W, Wu C, Dornbos D 3rd, Li S, Song H, Wang Y, Ding Y, Ji X. Multiphase adjuvant neuroprotection: A novel paradigm for improving acute ischemic stroke outcomes. Brain Circ. 2020 Feb 18;6(1):11-18. doi: 10.4103/bc.bc_58_19. eCollection 2020 Jan-Mar.
PubMed 32166195Zhao W, Li S, Ren C, Meng R, Jin K, Ji X. Remote ischemic conditioning for stroke: clinical data, challenges, and future directions. Ann Clin Transl Neurol. 2018 Nov 15;6(1):186-196. doi: 10.1002/acn3.691. eCollection 2019 Jan.
PubMed 30656197
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof-of-Concept Study Assessing the Safety and Efficacy of Remote Ischemic Conditioning for Acute Ischemic Stroke Patients Undergoing Endovascular Treatment
- ClinicalTrials.gov ID
- NCT03045055
- Acronym / sponsor ID
- REVISE-2 / REVISE-2
- Conditions
- Acute Stroke
- Keywords
- Acute ischemic stroke, Endovascular treatment, Remote ischemic conditioning
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Collaborators
- Shengli Oilfield Hospital
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 7 Feb 2017 (estimated)
- 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.
Ischemic stroke, which is due to the occlusion of a cerebral blood vessel, comprises nearly 80-90% of all strokes. Currently, reperfusion of the salvageable tissue via thrombolytic drug or endovascular treatment is the most effective strategy to reduce brain damage. However, after recanalizing the occluded vessels, subsequent reperfusion injury is inevitable. It may not only weaken the therapeutic effects of timely reperfusion but also impede patients' recovery. Moreover, thousands of neuroprotective drugs effective in experimental models have been proved to be unsuccessful in clinical trials. Therefore, effective strategies are urgently needed to prevent and treat cerebral reperfusion injury and further improve the prognosis of acute ischemic stroke.
Researchers applied remote ischemic conditioning to mouse model of focal cerebral reperfusion injury and found that it could reduce cerebral infarct size. And clinical researches demonstrated that remote ischemic conditioning was an effective strategy to improve cerebral perfusion and prevent recurrent stroke in patients with ischemic stroke. However, whether remote ischemic conditioning is safe and effective in protecting patients with large-vessel ischemic stroke and undergoing endovascular treatment is still unclear. The investigators' hypothesis is that RIC is a safe and effective strategy to reduce brain injuries in stroke 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 |
|---|---|---|
| RIC group | Experimental | Device: Remote ischemic conditioning., Procedure: Endovascular treatment.RIC (remote ischemic conditioning) paired with endovascular treatment. |
| Sham group | Sham comparator | Procedure: Endovascular treatment., Device: Sham remote ischemic conditioningSham RIC (remote ischemic conditioning) paired with endovascular treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Acute ischemic stroke where patient is ineligible for intravenous thrombolytic treatment or the treatment is contraindicated, or where patient has received intravenous thrombolytic therapy without recanalization;
- Suspected proximal anterior circulation occlusion;
- No remarkable pre-stroke functional disability (mRS ≤ 1);
- Baseline NIHSS score obtained prior to randomization must be ≥6;
- Age ≥18 and ≤ 80;
Key exclusion criteria (20 listed)
- Identified hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR > 3.0;
- Baseline platelet count < 30*109/L;
- Baseline blood glucose of < 2.7mmol/L or >22.2mmol/L;
- Renal insufficiency with creatinine ≥ 265 umol/L;
- Severe, sustained hypertension (SBP > 185 mmHg or DBP > 110 mmHg);
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 conditioning.Also: RICThe RIC procedure consists of four cycles of unilateral arm ischemia for 5 minutes, which was followed by reperfusion for another 5 minutes. The procedure is performed with an electric, autocontrol device with a cuff that inflated to a pressure of 200 mmHg during the ischemia period. RIC is performed before recanalization of the occluded artery, immediately following successful recanalization, and once daily for the subsequent 7 days. | Device | RIC group |
| Endovascular treatment.Endovascular treatment of acute ischemic stroke is performed by experienced neuroradiologist according to the latest guideline from American Heart Association and American Stroke Association.It includes thrombectomy, intra-arterial thrombolysis, thrombus aspiration, stenting and balloon angioplasty. | Procedure or surgery | RIC group, Sham group |
| Sham remote ischemic conditioningAlso: Sham RICThe sham RIC procedure consists of four cycles of unilateral arm ischemia for 5 minutes, which was followed by reperfusion for another 5 minutes. The procedure is performed with an electric, autocontrol device with a cuff that inflated to a pressure of 30 mmHg during the ischemia period. Sham RIC is performed before recanalization of the occluded artery, immediately following successful recanalization, and once daily for the subsequent 7 days. | Device | Sham group |
Primary outcome
Cerebral infarction volume.
Time frame: 7 days after stroke onset.
The cerebral infarction volume is evaluated on cerebral imaging.
5 secondary outcomes
The proportion of enrolled subjects that completed all the designed RIC procedures.
Time frame: 0-7 days.
The severity of global disability at 90 days, as assessed by modified Rankin scale (mRS).
Time frame: 0-90 days.
Change in NIHSS.
Time frame: 0-90 days.
Symptomatic Intracerebral Hemorrhage.
Time frame: 0-90 days.
Safety - Assessment of adverse events and serious adverse events.
Time frame: 0-90 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2020.
- Background: PubMed 27766474Hausenloy DJ, Barrabes JA, Botker HE, Davidson SM, Di Lisa F, Downey J, Engstrom T, Ferdinandy P, Carbrera-Fuentes HA, Heusch G, Ibanez B, Iliodromitis EK, Inserte J, Jennings R, Kalia N, Kharbanda R, Lecour S, Marber M, Miura T, Ovize M, Perez-Pinzon MA, Piper HM, Przyklenk K, Schmidt MR, Redington A, Ruiz-Meana M, Vilahur G, Vinten-Johansen J, Yellon DM, Garcia-Dorado D. Ischaemic conditioning and targeting reperfusion injury: a 30 year voyage of discovery. Basic Res Cardiol. 2016 Nov;111(6):70. doi: 10.1007/s00395-016-0588-8. Epub 2016 Oct 20.
- Background: PubMed 28174194Zhao W, Meng R, Ma C, Hou B, Jiao L, Zhu F, Wu W, Shi J, Duan Y, Zhang R, Zhang J, Sun Y, Zhang H, Ling F, Wang Y, Feng W, Ding Y, Ovbiagele B, Ji X. Safety and Efficacy of Remote Ischemic Preconditioning in Patients With Severe Carotid Artery Stenosis Before Carotid Artery Stenting: A Proof-of-Concept, Randomized Controlled Trial. Circulation. 2017 Apr 4;135(14):1325-1335. doi: 10.1161/CIRCULATIONAHA.116.024807. Epub 2017 Feb 7.
- Background: PubMed 30009202Zhao W, Che R, Li S, Ren C, Li C, Wu C, Lu H, Chen J, Duan J, Meng R, Ji X. Remote ischemic conditioning for acute stroke patients treated with thrombectomy. Ann Clin Transl Neurol. 2018 Jun 6;5(7):850-856. doi: 10.1002/acn3.588. eCollection 2018 Jul.
- Background: PubMed 32166195Zhao W, Wu C, Dornbos D 3rd, Li S, Song H, Wang Y, Ding Y, Ji X. Multiphase adjuvant neuroprotection: A novel paradigm for improving acute ischemic stroke outcomes. Brain Circ. 2020 Feb 18;6(1):11-18. doi: 10.4103/bc.bc_58_19. eCollection 2020 Jan-Mar.
- Background: PubMed 30656197Zhao W, Li S, Ren C, Meng R, Jin K, Ji X. Remote ischemic conditioning for stroke: clinical data, challenges, and future directions. Ann Clin Transl Neurol. 2018 Nov 15;6(1):186-196. doi: 10.1002/acn3.691. eCollection 2019 Jan.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Remote ischemic conditioning. and Endovascular treatment. in people with Acute Stroke, run by Capital Medical University.
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 7 inclusion and 20 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 27 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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 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.
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 PhD (861013120136877, jixunming@vip.163.com; zhaowb.cmu@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral infarction volume. (time frame: 7 days after stroke onset.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03045055, which also lists 5 linked publications.
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 27 Jul 2020.