NCT03105141

Brief Summary

This prospective, randomized, single-center clinical trial is designed to figure out the most optimal algorithm of remote ischemic conditioning on patients with chronic cerebral ischemia.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 7, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

December 5, 2017

Status Verified

December 1, 2017

Enrollment Period

1.8 years

First QC Date

April 2, 2017

Last Update Submit

December 2, 2017

Conditions

Chronic Cerebral IschemiaIntracranial Atherosclerosis

Keywords

Intracranial atherosclerotic stenosisRemote ischemic conditioningStroke

Outcome Measures

Primary Outcomes (1)

  • Recurrent rate of ischemic stroke and/or transient ischemic attack

    baseline, within 12 months

Secondary Outcomes (14)

  • Treatment Related Adverse Events

    within 12 months

  • The incidence of composite vascular events

    within 12 months

  • The incidence of each component of composite vascular events

    within 12 months

  • The incidence of all cause mortality

    within 12 months

  • The evaluation of cognitive function

    baseline, within 3, 6 and 12 months

  • +9 more secondary outcomes

Study Arms (4)

RIC substudy 1

EXPERIMENTAL

A total of 120 patients in this substudy will receive standard medical therapy and bilateral upper limb remote ischemic conditioning intervention (Doctormate®) (200 mmHg or 40 mmHg above systolic pressure) twice daily for 12 months.

Device: Remote ischemic conditioning

RIC substudy 2

EXPERIMENTAL

A total of 180 patients in this substudy will receive standard medical therapy and bilateral upper limb remote ischemic conditioning intervention (Doctormate®) (200 mmHg) twice daily for 12 months.

Device: Remote ischemic conditioning

RIC substudy 3

EXPERIMENTAL

A total of 180 patients in this substudy will receive standard medical therapy and bilateral upper limb remote ischemic conditioning intervention (Doctormate®) (200 mmHg) twice daily for 12 months.

Device: Remote ischemic conditioning

RIC substudy 4

EXPERIMENTAL

A total of 120 patients in this substudy will receive standard medical therapy and bilateral upper limb remote ischemic conditioning intervention (Doctormate®) (200 mmHg) once or twice daily for 12 months.

Device: Remote ischemic conditioning

Interventions

Remote ischemic conditioningDEVICE

Remote ischemic conditioning is composed of 5 cycles of 5-min bilateral upper limb ischemia intervened by 5-min reperfusion, which is induced by an automated cuff-inflator (Doctormate®) placed on both upper arms and inflated to a given pressure followed by deflation, twice daily for 12 months. Two different magnitude of limb ischemia pressure will be set: 200 mmHg and 40 mmHg above systolic pressure (60 patients for each). Optimal inflating pressure will be determined based on the results.

RIC substudy 1

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Age ranging from 45 to 80 years of age, both genders;
  • \. Patients diagnosed with an ischemic stroke or TIA before admission and the following requirements should be satisfied as well:
  • The occurrence of an ischemic stroke within 30 days and with a baseline modified Rankin Scale (mRS) score≤4.
  • The occurrence of an TIA within 15 days and with a baseline Oxfordshire Community Stroke Project on the basis of age, blood pressure (BP), clinical features, and duration of TIA symptoms (ABCD2) score≥4.
  • \. Patients with symptomatic intracranial atherosclerotic stenosis (sIAS) that is attributed to at least 50% stenosis of the diameter of a major intracranial artery (carotid artery, or middle cerebral artery (M1)) verified by magnetic resonance angiography (MRA) or computed tomographic angiography (CTA).
  • \. Informed consent obtained patients or health care proxy, as appropriate, able to cooperate and participate follow-up visits.

You may not qualify if:

  • \. Intracranial arterial stenosis due to any of the following non-atherosclerotic etiologies, for instance, moyamoya disease, artery dissection, any known vasculitic disease, any intracranial infection, radiation induced vasculopathy, cerebrospinal fluid (CSF) pleocytosis associated intraarterial stenosis, genetic or developmental abnormalities such as fibromuscular dysplasia, neurofibromatosis, sickle cell disease, and mitochondrial encephalopathy, intracranial granulomatous arteritis, postpartum angiopathy, suspected vasospasm or embolism, iatrogenic trauma.
  • \. Intracranial abnormalities such as tumor, abscess, vascular malformation, cerebral venous sinus stenosis or thrombosis.
  • \. Any hemorrhagic transformation or large area of cerebral infarction (more than 1/3 of middle cerebral artery perfusion territory).
  • \. Potential cardiac source of embolism such as rheumatic mitral and or aortic stenosis, prosthetic heart valves, atrial flutter, atrial fibrillation, left atrial myxoma, sick sinus syndrome, patent foramen ovale, left ventricular mural thrombus or valvular vegetation, congestive heart failure, and bacterial endocarditis.
  • \. Refractory hypertension (systolic blood pressure (SBP) \>180 mmHg; diastolic blood pressure (DBP) \>110 mmHg) that cannot be controlled by medical intervention.
  • \. Above 50% stenosis of extracranial artery (carotid artery or vertebral artery).
  • \. Above 50% stenosis of subclavian artery or subclavian steal syndrome.
  • \. Severe hemostatic or coagulation disorders (Haemoglobin \<10 g/dL, blood platelet count \< 100 × 109/L).
  • \. Hepatic or renal dysfunctions (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)).
  • \. Current or having a history of chronic physical diseases or mental disorders.
  • \. Life expectancy \< 3 years due to concomitant life-threatening illness.
  • \. Contraindications for remote ischemic conditioning: significant peripheral arterial disease, soft tissue or vascular injury, wounds, and fracture affecting the upper limbs.
  • \. Pregnant or lactating women.
  • \. Patients unlikely to be compliant with intervention or return for follow-up visits.
  • \. No consent obtained from the patient or available legally authorized representatives.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

Xuanwu Hospital, Capital Medical University

Beijing, 100053, China

RECRUITING

Related Publications (3)

  • Meng R, Asmaro K, Meng L, Liu Y, Ma C, Xi C, Li G, Ren C, Luo Y, Ling F, Jia J, Hua Y, Wang X, Ding Y, Lo EH, Ji X. Upper limb ischemic preconditioning prevents recurrent stroke in intracranial arterial stenosis. Neurology. 2012 Oct 30;79(18):1853-61. doi: 10.1212/WNL.0b013e318271f76a. Epub 2012 Oct 3.

    PMID: 23035060BACKGROUND

  • Meng R, Ding Y, Asmaro K, Brogan D, Meng L, Sui M, Shi J, Duan Y, Sun Z, Yu Y, Jia J, Ji X. Ischemic Conditioning Is Safe and Effective for Octo- and Nonagenarians in Stroke Prevention and Treatment. Neurotherapeutics. 2015 Jul;12(3):667-77. doi: 10.1007/s13311-015-0358-6.

    PMID: 25956401BACKGROUND

  • Wang Y, Zhao X, Liu L, Soo YO, Pu Y, Pan Y, Wang Y, Zou X, Leung TW, Cai Y, Bai Q, Wu Y, Wang C, Pan X, Luo B, Wong KS; CICAS Study Group. Prevalence and outcomes of symptomatic intracranial large artery stenoses and occlusions in China: the Chinese Intracranial Atherosclerosis (CICAS) Study. Stroke. 2014 Mar;45(3):663-9. doi: 10.1161/STROKEAHA.113.003508. Epub 2014 Jan 30.

    PMID: 24481975BACKGROUND

MeSH Terms

Conditions

Intracranial ArteriosclerosisStroke

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Xuming Ji, MD, PhD

    Xuanwu Hospital, Beijing

    PRINCIPAL INVESTIGATOR

  • Ran Meng, MD, PhD

    Xuanwu Hospital, Beijing

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ran Meng, MD, PhD

CONTACT

+86-10-83198952Ranmeng2011@pku.org.cn

Da Zhou, MD, PhD Candidate

CONTACT

+86-10-83198952popdoctor@foxmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice President, Professor, Xuanwu Hospital

Study Record Dates

First Submitted

April 2, 2017

First Posted

April 7, 2017

Study Start

June 1, 2017

Primary Completion

April 1, 2019

Study Completion

January 1, 2020

Last Updated

December 5, 2017

Record last verified: 2017-12

Locations

CN(2)