Prevention of Ischemic Conditions in Non-disabling Stroke/Transient Ischemic Attack With Remote Ischemic Conditioning

NCT03004820 | Completed DMC

• 1 other identifier: RICMIS/TIA
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 4

Brief Summary

This is a single-arm, open-labeled and phase II futility study. Application of Remote ischemic conditioning (RIC) as an adjunctive therapy to medication were involved in the study. The study is to test whether RIC is effective in preventing ischemic evens after a minor ischemic stroke/transient ischemic attack within 3 months and to explore the safety and compliance of chronic RIC. Medication strategy is based on physician's best judgement.

Conditions

Transient Ischemic Attack; Non-disabling Stroke

Keywords

Minor Ischemic Stroke; Transient Ischemic Attack; Remote Ischemic Conditioning

Outcome Measures

Primary Outcomes (1)

• Recurrent rate of ischemic stroke/transient ischemic stroke

  within 3 months

Secondary Outcomes (6)

• Treatment-Related Adverse Events

  within 3 months

• Compliance of remote ischemic conditioning

  within 3 months

• Incidence rate of vascular events

  within 3 months

• Improvements in NIH Stroke Scale

  within1, 3 months

• Improvements in modified Rankin Scale

  within 1, 3 months

Other Outcomes (1)

• Recurrent rate of ischemic stroke/transient ischemic stroke within 1 months

  within 1 months

Study Arms (1)

Remote Ischemic Conditioning

EXPERIMENTAL

RIC (remote ischemic conditioning) consists of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on bilateral upper limbs twice a day. Medication strategy is based on physician's best judgement.

Device: Remote Ischemic Conditioning

Interventions

Remote Ischemic Conditioning DEVICE

RIC consist of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on bilateral upper limbs twice a day. Medication strategy is based on physician's best judgement.

Remote Ischemic Conditioning

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eighteen years old or older of any gender or race;
• Stable vital signs, normal cardiac, hepatic and renal functions;
• Able to consent by himself/herself or by legally authorized representative.

You may not qualify if:

• Diagnosis of hemorrhage or other pathology, such as vascular malformation, tumor, abscess or other non-vascular diseases, based on brain CT or MRI;
• Received iv. recombinant tissue plasminogen activator (rtPA) therapy or interventional treatment for the current event;
• Contradiction for aspirin or clopidogrel (known allergy, severe asthma or heart failure et al.) ;
• Clear indication for anticoagulation therapy ( cardiac source of embolus);
• Hemorrhagic tendency of any reason （including but not limit to Hemostatic disorder, platelet count \<100 × 109/L, history of drug-induced hepatic dysfunction）;
• Any hemorrhagic transformation;
• Gastrointestinal bleed or major surgery within 3 months of symptoms onset;
• Stroke or TIA induced by interventional therapy or surgery;
• Any upper extremity soft tissue, vascular injury or peripheral blood vessel disease which may contraindicate RIC;
• Systolic blood pressure greater than 200 mmHg after medication;
• Planned revascularization (any angioplasty or vascular surgery) within the next 3 months ；
• Scheduled for surgery or interventional treatment requiring RIC cessation within next 3 months;
• Severe noncardiovascular comorbidity with life expectancy \< 3 months;
• Pregnancy;
• Currently receiving an investigational drug or device by other studies.

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (4)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

First Affiliated Hospital of Hainan Medical University

Haikou, Hainan, 570102, China

Location

Taoyuan People's Hospital

Changde, Hunan, China

Location

Shengli Oilfield Center Hospital

Dongying, Shandong, 257034, China

Location

Related Publications (1)

• Liu SM, Zhao WL, Song HQ, Meng R, Li SJ, Ren CH, Ovbiagele B, Ji XM, Feng WW. Rationale and Study Design for a Single-Arm Phase IIa Study Investigating Feasibility of Preventing Ischemic Cerebrovascular Events in High-Risk Patients with Acute Non-disabling Ischemic Cerebrovascular Events Using Remote Ischemic Conditioning. Chin Med J (Engl). 2018 Feb 5;131(3):347-351. doi: 10.4103/0366-6999.223849.

  PMID: 29363651 DERIVED

MeSH Terms

Conditions

Ischemic Attack, Transient

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Xunming Ji, MD, PhD

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

• Wuwei Feng, MD, MS

  Medical University of South Carolina

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chief Surgeon, Vice President

Model Details: Patients will receive remote ischemic conditioning

Study Record Dates

• First Submitted: December 10, 2016
• First Posted: December 29, 2016
• Study Start: December 6, 2016
• Primary Completion: October 19, 2017
• Study Completion: October 19, 2017
• Last Updated: January 31, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)