Limb Remote Ischemic Conditioning and Cerebrovascular Reserve
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| ClinicalTrials.gov Identifier: NCT03589053 |
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Recruitment Status : Unknown
Verified October 2018 by Ji Xunming,MD,PhD, Capital Medical University.
Recruitment status was: Recruiting
First Posted : July 17, 2018
Last Update Posted : October 9, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Ischemic Cerebrovascular Disease | Device: Limb remote ischemic conditioning Device: Control group | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 30 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Effects of Limb Remote Ischemic Conditioning (LRIC) on Cerebrovascular Reserve (CVR) in Ischemic Cerebrovascular Disease Patients |
| Estimated Study Start Date : | October 8, 2018 |
| Estimated Primary Completion Date : | December 30, 2018 |
| Estimated Study Completion Date : | March 30, 2019 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: LRIC group
Participants in the experimental group receive both LRIC and standard clinical therapy. The LRIC treatment is composed of 5 cycles of bilateral upper limb ischemia for 5 minutes followed by reperfusion for another 5 minutes performed twice a day for a total of 90 consecutive days.The procedure was performed by using an electric autocontrol device with cuffs that inflated to a pressure of 200 mmHg during the ischemic period and deflated during the reperfusion (Patent No.CN200820123637.X, China).
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Device: Limb remote ischemic conditioning
The LRIC treatment consisted of 5 cycles of bilateral upper limb ischemia for 5 minutes followed by reperfusion for another 5 minutes performed twice a day for a total of 90 consecutive days.The procedure was performed by using an electric autocontrol device with cuffs that inflated to a pressure of 200 mmHg during the ischemic period and deflated during the reperfusion. |
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Sham Comparator: Control group
Participants in the control group receive both sham LRIC and standard clinical therapy.
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Device: Control group
Participants in the control group receive both sham LRIC and standard clinical therapy. |
- Change of cerebrovascular reserve [ Time Frame: 90 days ]We evaluate the compensatory capacity of cerebral blood vessels and brain tissue by the rate of changes in cerebral blood flow and brain metabolism under stress and resting conditions, respectively.
- Recurrence of stroke [ Time Frame: 90 days ]
- Safety of LRIC [Number of patients not tolerating RIC procedure and patients with erythema or skin lesions related to RIC] [ Time Frame: 90 days ]The safety of LRIC by the number of patients not tolerating RIC procedure and patients with erythema or skin lesions related to RIC.
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- (1)Symptomatic intracranial arterial stenosis measuring >=50% by angiography or >=70% by ultrasound, CT angiography (CTA), or magnetic resonance angiography (MRA);(2)Age range 18-80 years;(3)Compared with normal brain tissue, the reduction of cerebral glucose metabolism (CGM) and/ or cerebral blood flow (CBF) in the focal area>=8%;(4)Stable vital signs, normal renal and hepatic functions; (5)No hemorrhagic tendency;(6)Subject or his or her legally authorized representative was able to provide an informed conised.
Exclusion Criteria:
-(1)Uncontrolled hypertension (defined as systolic blood pressure>=200 mmHg despite medications at enrollment); (2)Any vascular, soft tissue, or orthopedic injury (eg, superficial wounds and fractures of the arm) that contraindicated bilateral arm ischemic preconditioning;(3)Peripheral vascular disease (especially subclavian arterial and upper limb artery stenosis or occlusion); (4)Hematologic disease;(5)Severe or unstable concomitant disease;(6)Can not tolerate LRIC treatment;(7)No informed consent.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03589053
| Contact: Xunming Ji, MD.PhD | +86-10-83198952 | jixunming@vip.163.com |
| China, Beijing | |
| Xunming Ji | Recruiting |
| Beijing, Beijing, China, 100053 | |
| Contact: Hong An, MD anhong0622@163.com | |
| Principal Investigator: | Xunming Ji | Capital Medical University |
| Responsible Party: | Ji Xunming,MD,PhD, professor, Capital Medical University |
| ClinicalTrials.gov Identifier: | NCT03589053 |
| Other Study ID Numbers: |
LRIC-CVR |
| First Posted: | July 17, 2018 Key Record Dates |
| Last Update Posted: | October 9, 2018 |
| Last Verified: | October 2018 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Limb remote ischemic conditioning Cerebrovascular reserve |
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Cerebrovascular Disorders Ischemia Pathologic Processes Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |