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Intracranial AtherosclerosisNCT02534545

Remote Ischemic Conditioning for Avoiding Recurrence of Symptomatic Intracranial Atherosclerotic Stenosis (sICAS)

A study testing Doctormate® (200mmHg) and Doctormate® (60mmHg) in people with Intracranial Atherosclerosis, run by Ji Xunming,MD,PhD at 50 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The primary objective of the study will be to determine whether remote limb ischemic conditioning (RLIC) compared with sham RLIC (placebo) treatment reduces the 12-month risk of recurrent IS in patients with a recent TIA or IS caused by stenosis of a major intracranial artery. Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Intracranial Atherosclerosis
What is being tested?
Doctormate® (200mmHg) and Doctormate® (60mmHg)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3,000 participants
Where
50 sitesChina
Study dates
Oct 2015to Sep 2019
Phase
Interventional
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 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female with age from 40 to 80 years old.
  • Patients having an ischemic stroke or a TIA prior to randomization.
  • Patient having an ischemic stroke within 30 days with mRS score≤4 at baseline.
  • Patient having a TIA within 15 days with Oxfordshire Community Stroke Project on the basis of age, blood pressure (BP), clinical features, and duration of TIA symptoms (ABCD2) score≥4 at baseline.
  • The entry event is attributed to symptomatic atherosclerotic stenosis (50-99%) in an intracranial qualifying artery (carotid artery, middle cerebral artery (M1), vertebral artery, or basilar artery) that is documented by magnetic resonance angiography (MRA) or computed tomographic angiography (CTA).
  • Informed consent obtained.

Who cannot join

  • Thrombolytic therapy within 24 hours prior to enrollment.
  • Progressive neurological signs within 24 hours prior to enrollment.
  • Cerebral venous thrombosis/stenosis.
  • Intracranial arterial stenosis due to arterial dissection, Moya Moya disease; any known vasculitic disease; herpes zoster, varicella zoster or other viral vasculopathy; neurosyphilis; any other intracranial infection; any intracranial stenosis associated with cerebrospinal fluid (CSF) pleocytosis; radiation induced vasculopathy; fibromuscular dysplasia; sickle cell disease; neurofibromatosis; benign angiopathy of central nervous system; post-partum angiopathy; suspected vasospastic process, suspected recanalized embolus.
  • Any of the following unequivocal cardiac source of embolism: rheumatic mitral and or aortic stenosis, prosthetic heart valves, atrial fibrillation, atrial flutter, sick sinus syndrome, left atrial myxoma, patent foramen ovale, left ventricular mural thrombus or valvular vegetation, congestive heart failure, bacterial endocarditis, or any other cardiovascular condition interfering with the participation.
  • Uncontrolled severe hypertension [sitting systolic blood pressure (SBP) >180 mmHg and/or sitting diastolic blood pressure (DBP) >110 mmHg after medication].
Show all 21Show fewer
  • Patients with abnormal laboratory parameters: aspartate transaminase (AST) and/or alanine transaminase (ALT) >3×upper limit of normal range; creatinine clearance <0.6 ml/s and/or serum creatinine >265 μmol/l (>3.0 mg/dl); platelets <100×109/L.
  • Any intracranial hemorrhage (parenchymal, subarachnoid, subdural, epidural) within 90 days prior to enrollment.
  • Intracranial neoplasm, cerebral aneurysm or arteriovenous malformation.
  • Known retinal hemorrhage or visceral bleeding within 30 days prior to enrollment.
  • Severe hemostatic disorder or severe coagulation dysfunction.
  • Subclavian arterial stenosis≥50% or subclavian steal syndrome.
  • Extracranial stenosis ≥50%.
  • Previous treatment of target lesion with a stent, angioplasty, or other mechanical device, or plan to perform one of these procedures within 12 months after enrollment.
  • Major surgery (including open femoral, aortic, or carotid surgery, cardiac) within previous 30 days or scheduled in the 12 months after enrollment.
  • Contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs.
  • Life expectancy<3 years.
  • Pregnant or breast-feeding women.
  • Unwilling to be followed up or poor compliance for treatment.
  • Patients being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial.
  • Patients unsuitable for enrollment in the clinical trial according to investigators decision making.

Trial locations and contacts

50 sites in 1 country.

Xunming Ji, MD. PhD contact

+86-10-83198952

jixunming@vip.163.com

50 sites in 1 country

China50 sites, 50 recruiting

  • Ankang City Central Hospital

    Ankang, Shaanxi

    Kaifu Jiang

    Kaifu Jiang

    Recruiting

  • Anshanshi Changda The Hospital

    Anshan, Liaoning

    Xiujie Han

    Xiujie Han

    Recruiting

  • Baoding No.1 Hospital

    Baoding, Hebei

    Chunsheng Wang

    Chunsheng Wang

    Recruiting

  • The Hospital of Shunyi District Beijing

    Beijing, Beijing Municipality, 101300

    Quping Ouyang

    Quping Ouyang

    Recruiting

  • Beijing Huairou Hospital

    Beijing, Beijing Municipality

    Fuying Yu

    Fuying Yu

    Recruiting

  • Xuanwu Hospital, Capital Medical University

    Beijing, 100053

    Xunming Ji

    Xunming Ji

    Recruiting

  • Beijing Aerospace General Hospital

    Beijing

    Jilai Li

    Jilai Li

    Recruiting

  • Beijing Luhe Hospital, Capital Medical University

    Beijing

    Huishan Du

    Huishan Du

    Recruiting

  • Xiyuan Hospital, China Academy of Chinses Medical Sciences

    Beijing

    Chenguang Tong

    Chenguang Tong

    Recruiting

  • Cangzhou People Hospital

    Cangzhou, Hebei

    Jie Huang

    Jie Huang

    Recruiting

  • Hebei Province Cangzhou Hospital of Integrated Traditional and Western Medicine

    Cangzhou, Hebei

    Zhiyong Wang

    Zhiyong Wang

    Recruiting

  • Peace Hospital Affiliated to Changzhi Medical College Shanxi Province

    Changzhi, Shanxi

    Yufen Wang

    Yufen Wang

    Recruiting

  • Changzhou NO.2 People's Hospital

    Changzhou, Jiangsu

    Zhuoyou Chen

    Zhuoyou Chen

    Recruiting

  • Chaoyang Central Hospital

    Chaoyang, Liaoning

    Xiaomei He

    Xiaomei He

    Recruiting

  • Chengde Central Hospital

    Chengde, Hebei

    Haisong Du

    Haisong Du

    Recruiting

  • Dalian Municipal Central Hospital Affiliated of Dalian Medical University

    Dalian, Liaoning

    Hong Wang

    Hong Wang

    Recruiting

  • Dezhou People's Hospital

    Dezhou, Shandong

    Shaohua Su

    Shaohua Su

    Recruiting

  • Shengli Oilfield Central Hospital

    Dongying, Shandong

    Zongen Gao

    Zongen Gao

    Recruiting

  • Fenyang Hospital of Shanxi Medical Unversity

    Fenyang, Shanxi

    Xueying Guo

    Xueying Guo

    Recruiting

  • Handan First Hospital

    Handan, Hebei

    Liping Cheng

    Liping Cheng

    Recruiting

  • The First Clinical Hospital affiliated to Harbin Medical University

    Harbin, Heilongjiang

    Guozhong Li

    Guozhong Li

    Recruiting

  • The Fourth Hospital of Harbin Medical University

    Harbin, Heilongjiang

    Zhuobo Zhang

    Zhuobo Zhang

    Recruiting

  • Inner Mongolia People's Hospital

    Hohhot, Inner Mongolia

    Runxiu Zhu

    Runxiu Zhu

    Recruiting

  • Jinzhou Central Hopital

    Jinzhou, Liaoning

    Dongyu Wang

    Dongyu Wang

    Recruiting

  • The Third Affiliated Hospital of Liaoning Medical College

    Jinzhou, Liaoning

    Hui Zhang

    Hui Zhang

    Recruiting

  • Linyi People's Hospital

    Linyi, Shandong

    Hongxing Han

    Hongxing Han

    Recruiting

  • Luohe Central Hospital

    Luohe, Henan

    Chunling Zheng

    Chunling Zheng

    Recruiting

  • Rizhao Hospital of Traditional Chinese Medicine

    Rizhao, Shandong

    Wei Ding

    Wei Ding

    Recruiting

  • Shangqiu First People's Hospital

    Shangqiu, Henan

    Yan Fang

    Yan Fang

    Recruiting

  • Shaoxing Central Hospital

    Shaoxing, Zhejiang

    Ke Shen

    Ke Shen

    Recruiting

  • The First People's Hospital of Shenyang

    Shenyang, Liaoning

    Jin Zhou

    Jin Zhou

    Recruiting

  • The General Hospital of Shenyang Military

    Shenyang, Liaoning

    Huisheng Chen

    Huisheng Chen

    Not yet recruiting

  • The Peoele's Hospital of Liaoning Province

    Shenyang, Liaoning

    Xiaohong Chen

    Xiaohong Chen

    Recruiting

  • Hebei General Hospital

    Shijiazhuang, Hebei

    Peiyuan Lu

    Peiyuan Lu

    Recruiting

  • Shijiazhuang The First Hospital

    Shijiazhuang, Hebei

    Zhenquan Yan

    Zhenquan Yan

    Recruiting

  • Shijiazhuang The Third Hospital

    Shijiazhuang, Hebei

    Yunshu Zhang

    Yunshu Zhang

    Recruiting

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei

    Xueqin Song

    Xueqin Song

    Recruiting

  • First Hospital of Shanxi Medical Unversity

    Taiyuan, Shanxi

    Xiaoyuan Niu

    Xiaoyuan Niu

    Recruiting

  • Shanxi College of Traditional Chinese Medicine Hospital

    Taiyuan, Shanxi

    Aimei Wang

    Aimei Wang

    Recruiting

  • Tianjin 4th Centre Hospital

    Tianjin, Tianjin Municipality

    Hongxin Wang

    Hongxin Wang

    Recruiting

  • Tianjin Huanhu Hospital

    Tianjin, Tianjin Municipality

    Wei Yue

    Wei Yue

    Recruiting

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality

    Junwei Hao

    Junwei Hao

    Recruiting

  • Affiliated Hospital of Weifang Medical University

    Weifang, Shandong

    Xianwei Zeng

    Xianwei Zeng

    Recruiting

  • Technology The Central Hospital of Wuhan

    Wuhan, Hubei

    Linhong Zhang

    Linhong Zhang

    Recruiting

  • Wuhu NO.2 People's Hospital

    Wuhu, Anhui

    Hongbo Pang

    Hongbo Pang

    Recruiting

  • The Third Houspital of Xingtai

    Xingtai, Hebei

    Yuqing Wei

    Yuqing Wei

    Recruiting

  • Xingtai People's Hospital

    Xingtai, Hebei

    Peilin Hu

    Peilin Hu

    Recruiting

  • Xuchang Central Hospital

    Xuchang, Henan

    Tao Li

    Tao Li

    Recruiting

  • Zhoushan Putuo Hospital

    Zhoushan, Zhejiang

    Ming Wang

    Ming Wang

    Recruiting

  • Zhumadian Ctentral Hospital

    Zhumadian, Henan

    Xuezhang Lai

    Xuezhang Lai

    Recruiting

Other trials in China

About this study

Official title: Remote Ischemic Conditioning for Avoiding Recurrence of Ischemic Stroke in Patients With Symptomatic Intracranial Atherosclerotic Stenosis

The primary objective of the study will be to determine whether remote limb ischemic conditioning (RLIC) compared with sham RLIC (placebo) treatment reduces the 12-month risk of recurrent IS in patients with a recent TIA or IS caused by stenosis of a major intracranial artery.

After screening period, eligible patients will be randomly allocated into 2 groups. In addition, all participants receive an usual clinical therapy.

Read the detailed description

In this study, Patients in the RLIC group will be treated with Renqiao Remote Ischemic Conditioning Device (Doctormate®) (200mmHg) once daily for 12 months; patients in the sham RLIC group will be treated with the Renqiao Remote Ischemic Conditioning Device (Doctormate®) (60mmHg) once daily for 12 months. In the study, the RLIC treatment will be comprised of 5 cycles of bilateral upper limb ischemia and reperfusion, which will be induced by 2 cuffs placed around the upper arms respectively and inflated to 200mmHg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation. Sham RLIC treatment will be conducted using the same procedure but with a minimal inflation pressure of 60mmHg, which does not result in upper limb ischemia. In addition, all participants will have received their usual drug therapy according to local medical practice.

Being tested
Doctormate® (200mmHg), Doctormate® (60mmHg)
Keywords
Intracranial atherosclerotic stenosis, ischemia, remote ischemic conditioning, stroke
Medical subject headings
Intracranial Arteriosclerosis, Ischemia, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Doctormate® (200mmHg)Device

    Limb ischemia was induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®) inflating tourniquets to 200mmHg.

  • Doctormate® (60mmHg)Device

    Limb ischemia was induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®) inflating tourniquets to 60mmHg.

Study groups in NCT02534545
Study groupRoleWhat they receive
Doctormate® (200mmHg)ExperimentalPatients will be treated with Renqiao Remote Ischemic Conditioning Device (Doctormate®) (200mmHg) once daily for 12 months
Receives: Device: Doctormate® (200mmHg)
Doctormate® (60mmHg)Sham comparatorPatients will be treated with the Renqiao Remote Ischemic Conditioning Device (Doctormate®) (60mmHg) once daily for 12 months
Receives: Device: Doctormate® (60mmHg)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The time from randomization to the first occurrence of fatal or non-fatal ischemic stroke.

    Measured: During the first 12 months from randomization.

Secondary outcomes (3)

  1. The time from randomization to the first occurrence of a composite of fatal or non-fatal stroke (ischemic and hemorrhagic), fatal or non-fatal myocardial infarction, and transient ischemic attack (TIA) .

    Measured: During the first 12 months from randomization.

  2. The time from randomization to the first occurrence of each component of the composite of fatal or non-fatal stroke (ischemic and hemorrhagic), fatal or non-fatal myocardial infarction, and TIA.

    Measured: During the first 12 months from randomization.

  3. Time to death from all causes from randomization.

    Measured: During the first 12 months from randomization.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionSep 2019 (estimated)
  4. Study completionSep 2019 (estimated)

Resources

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 N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
3,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02534545
Sponsor's protocol ID
RICA
Status last verified
May 2018
First submitted
23 Aug 2015
Last updated
24 May 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Hou C, Lan J, Lin Y, Song H, Wang Y, Zhao W, Li S, Meng R, Hao J, Ding Y, Chimowitz MI, Fisher M, Hess DC, Liebeskind DS, Hausenloy DJ, Huang J, Li Z, Han X, Yang J, Zhou J, Chen P, Zhu X, Hu P, Pang H, Chen W, Chen H, Li G, Tao D, Yue W, Gao Z, Ji X; RICA investigators. Chronic remote ischaemic conditioning in patients with symptomatic intracranial atherosclerotic stenosis (the RICA trial): a multicentre, randomised, double-blind sham-controlled trial in China. Lancet Neurol. 2022 Dec;21(12):1089-1098. doi: 10.1016/S1474-4422(22)00335-0. Epub 2022 Oct 27.

    PubMed 36354026

Questions about this trial

What is this clinical trial studying?

A study testing Doctormate® (200mmHg) and Doctormate® (60mmHg) in people with Intracranial Atherosclerosis, run by Ji Xunming,MD,PhD at 50 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 6 inclusion and 21 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 24 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 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.

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 (+86-10-83198952, jixunming@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The time from randomization to the first occurrence of fatal or non-fatal ischemic stroke. (time frame: During the first 12 months from randomization.). 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 NCT02534545, which also lists 1 linked publication.

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 24 May 2018.

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