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出境医 / 临床实验 / Remote Ischemic Conditioning for Intracerebral Hemorrhage (RICH)

Remote Ischemic Conditioning for Intracerebral Hemorrhage (RICH)

Study Description
Brief Summary:

Spontaneous intracerebral hemorrhage (ICH) results from the rupture of small vessels damaged by chronic hypertension, amyloid angiopathy or other disease. Hematoma volume has been demonstrated to be strongly correlated with the severity of white matter injury and conditions in ICH patients. In the past decades, surgical clot evacuation and stereotactic or endoscopic clot aspiration with thrombolytic drugs have been investigated for the treatment of ICH, however, none of them have been demonstrated to be effective. As such, medical management remains the standard of care for most patients with ICH, leading to ICH as the least treatable form of stroke.

Remote ischemic conditioning (RIC) has been found to have neuroprotective effects by in patients with ischemic stroke. In addition, animal studies show that RIC is safe in ICH model and it could accelerate the absorption of hematoma. Therefore, the investigators plan to undertake this study to evaluate the safety of RIC in patients with ICH, and planned for future study to determine if treatment with RIC can improve the outcome of patients with ICH.

In this study, our main objectives are: 1) to evaluated the safety of RIC, by determining the treatment related adverse events, in patients with ICH; and 2) to determine the preliminary effects of RIC on hematoma absorption and cerebral edema.

The investigators hypothesize that RIC is well-tolerated and has minimal serious adverse effects in patients with ICH; and that treatment with RIC will accelerate the absorption of hematoma and improve patients' functional outcomes. Results of this study can potentially bring into account new means to improve the outcomes of ICH patients.


Condition or disease Intervention/treatment Phase
Intracerebral Hemorrhage Device: remote ischemic conditioning Other: Regular treatment Phase 1

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safey and Efficacy of Remote Ischemic Conditioning in Patient With Spontaneous Intracerebral Hemorrhage
Actual Study Start Date : July 9, 2019
Actual Primary Completion Date : November 17, 2019
Actual Study Completion Date : February 10, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: RIC group
RIC treatment and regular treatment.
 Device: remote ischemic conditioning
RIC is a non-invasive therapy that performed by an electric autocontrol device with cuffs placed on arm and inflated to 200 mmHg for 5-min followed by deflation for 5-min, the procedures is performed repeatedly for 4 to 5 times.

Other: Regular treatment
Regular treatment is based on associated guidelines for ICH.
Control group
Regular treatment alone.
 Other: Regular treatment
Regular treatment is based on associated guidelines for ICH.
Outcome Measures
Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [Safety] [ Time Frame: 7 days. ]

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age≥18 and ≤80.
  2. The diagnosis of ICH is confirmed by brain CT scan.
  3. Hematoma volume of 10 to 30 ml.
  4. Glasgow Coma Score (GCS)>8.
  5. Starting RIC treatment between 24 and 48 hours of ictus.
  6. Signed and dated informed consented is obtained.

Exclusion Criteria:

  1. Patients with suspected secondary ICH related to tumor, coagulopathy, ruptured aneurysm or arteriovenous malformation, or venous sinus thrombosis.
  2. ICH concomitant with subarachnoid hemorrhage or intraventricular hemorrhage. Planned surgical evacuation of hematoma prior to RIC.
  3. Evidence of significant shift of midline brain structure (> 10 mm) or herniation on brain imaging.
  4. Known pregnancy (or positive pregnancy test), or breast-feeding.
  5. Concurrent participation in another research protocol for investigation of another experimental therapy.
  6. Patients with a pre-existing neurological deficits (modified Ranks scale score >1) or psychiatric disease that would confound the neurological or functional evaluations.
  7. Life expectancy of less than 90 days due to co-morbid conditions.
  8. Severe hepatic and renal dysfunction.
  9. Severe, sustained hypertension (SBP > 180 mmHg or DBP > 110 mmHg).
  10. Contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs.
  11. Any condition which, in the judgment of the investigator, might increase the risk to the patient.
Contacts and Locations

Locations
Layout table for location information
China
Xuanwu Hospital, Capital Medical University
Beijing, China, 100053
Sponsors and Collaborators
Capital Medical University
Heze Municipal Hospital
The Sixth People's Hosptial of Hengshui
Weihai Municipal Hospital
Investigators
Layout table for investigator information
Principal Investigator: Xunming Ji, MD, PhD Xuanwu Hospital, Capital Medical Univeristy
Tracking Information
First Submitted Date  ICMJE April 20, 2019
First Posted Date  ICMJE April 29, 2019
Last Update Posted Date February 11, 2020
Actual Study Start Date  ICMJE July 9, 2019
Actual Primary Completion Date November 17, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2019) 		Incidence of Treatment-Emergent Adverse Events [Safety] [ Time Frame: 7 days. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Remote Ischemic Conditioning for Intracerebral Hemorrhage
Official Title  ICMJE Safey and Efficacy of Remote Ischemic Conditioning in Patient With Spontaneous Intracerebral Hemorrhage
Brief Summary

Spontaneous intracerebral hemorrhage (ICH) results from the rupture of small vessels damaged by chronic hypertension, amyloid angiopathy or other disease. Hematoma volume has been demonstrated to be strongly correlated with the severity of white matter injury and conditions in ICH patients. In the past decades, surgical clot evacuation and stereotactic or endoscopic clot aspiration with thrombolytic drugs have been investigated for the treatment of ICH, however, none of them have been demonstrated to be effective. As such, medical management remains the standard of care for most patients with ICH, leading to ICH as the least treatable form of stroke.

Remote ischemic conditioning (RIC) has been found to have neuroprotective effects by in patients with ischemic stroke. In addition, animal studies show that RIC is safe in ICH model and it could accelerate the absorption of hematoma. Therefore, the investigators plan to undertake this study to evaluate the safety of RIC in patients with ICH, and planned for future study to determine if treatment with RIC can improve the outcome of patients with ICH.

In this study, our main objectives are: 1) to evaluated the safety of RIC, by determining the treatment related adverse events, in patients with ICH; and 2) to determine the preliminary effects of RIC on hematoma absorption and cerebral edema.

The investigators hypothesize that RIC is well-tolerated and has minimal serious adverse effects in patients with ICH; and that treatment with RIC will accelerate the absorption of hematoma and improve patients' functional outcomes. Results of this study can potentially bring into account new means to improve the outcomes of ICH patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Intracerebral Hemorrhage
Intervention  ICMJE
  • Device: remote ischemic conditioning
    RIC is a non-invasive therapy that performed by an electric autocontrol device with cuffs placed on arm and inflated to 200 mmHg for 5-min followed by deflation for 5-min, the procedures is performed repeatedly for 4 to 5 times.
  • Other: Regular treatment
    Regular treatment is based on associated guidelines for ICH.
Study Arms  ICMJE
  • Experimental: RIC group
    RIC treatment and regular treatment.
    Interventions:
    • Device: remote ischemic conditioning
    • Other: Regular treatment
  • Control group
    Regular treatment alone.
    Intervention: Other: Regular treatment
Publications *
  • Vaibhav K, Braun M, Khan MB, Fatima S, Saad N, Shankar A, Khan ZT, Harris RBS, Yang Q, Huo Y, Arbab AS, Giri S, Alleyne CH Jr, Vender JR, Hess DC, Baban B, Hoda MN, Dhandapani KM. Remote ischemic post-conditioning promotes hematoma resolution via AMPK-dependent immune regulation. J Exp Med. 2018 Oct 1;215(10):2636-2654. doi: 10.1084/jem.20171905. Epub 2018 Sep 6.
  • Zhao 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.
  • Zhao W, Zhang J, Sadowsky MG, Meng R, Ding Y, Ji X. Remote ischaemic conditioning for preventing and treating ischaemic stroke. Cochrane Database Syst Rev. 2018 Jul 5;7:CD012503. doi: 10.1002/14651858.CD012503.pub2. Review.
  • Zhao 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.
  • Zhao 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. Review.
  • Zhao W, Jiang F, Li S, Liu G, Wu C, Wang Y, Ren C, Zhang J, Gu F, Zhang Q, Gao X, Gao Z, Song H, Ma Q, Ding Y, Ji X; RICH-1 Investigators. Safety and efficacy of remote ischemic conditioning for the treatment of intracerebral hemorrhage: A proof-of-concept randomized controlled trial. Int J Stroke. 2021 Apr 7:17474930211006580. doi: 10.1177/17474930211006580. [Epub ahead of print]
  • Zhao W, Jiang F, Li S, Wu C, Gu F, Zhang Q, Gao X, Gao Z, Song H, Wang Y, Ji X; RICH-1 Investigators. Remote Ischemic Conditioning for Intracerebral Hemorrhage (RICH-1): Rationale and Study Protocol for a Pilot Open-Label Randomized Controlled Trial. Front Neurol. 2020 Apr 28;11:313. doi: 10.3389/fneur.2020.00313. eCollection 2020.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 25, 2019) 		40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 10, 2020
Actual Primary Completion Date November 17, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age≥18 and ≤80.
  2. The diagnosis of ICH is confirmed by brain CT scan.
  3. Hematoma volume of 10 to 30 ml.
  4. Glasgow Coma Score (GCS)>8.
  5. Starting RIC treatment between 24 and 48 hours of ictus.
  6. Signed and dated informed consented is obtained.

Exclusion Criteria:

  1. Patients with suspected secondary ICH related to tumor, coagulopathy, ruptured aneurysm or arteriovenous malformation, or venous sinus thrombosis.
  2. ICH concomitant with subarachnoid hemorrhage or intraventricular hemorrhage. Planned surgical evacuation of hematoma prior to RIC.
  3. Evidence of significant shift of midline brain structure (> 10 mm) or herniation on brain imaging.
  4. Known pregnancy (or positive pregnancy test), or breast-feeding.
  5. Concurrent participation in another research protocol for investigation of another experimental therapy.
  6. Patients with a pre-existing neurological deficits (modified Ranks scale score >1) or psychiatric disease that would confound the neurological or functional evaluations.
  7. Life expectancy of less than 90 days due to co-morbid conditions.
  8. Severe hepatic and renal dysfunction.
  9. Severe, sustained hypertension (SBP > 180 mmHg or DBP > 110 mmHg).
  10. Contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs.
  11. Any condition which, in the judgment of the investigator, might increase the risk to the patient.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03930940
Other Study ID Numbers  ICMJE RICH
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ji Xunming,MD,PhD, Xuanwu Hospital, Beijing
Study Sponsor  ICMJE Capital Medical University
Collaborators  ICMJE
  • Heze Municipal Hospital
  • The Sixth People's Hosptial of Hengshui
  • Weihai Municipal Hospital
Investigators  ICMJE
Principal Investigator: Xunming Ji, MD, PhD Xuanwu Hospital, Capital Medical Univeristy
PRS Account Capital Medical University
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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