Prevention of Ischemic Conditions in Non-disabling Stroke/Transient Ischemic Attack With Remote Ischemic Conditioning (PICNIC-ONE)

January 29, 2018 updated by: Ji Xunming, Capital Medical University

Feasibility of Applying Remote Ischemic Conditioning in Secondary Prevention in Patients With Minor Ischemic Stroke or Transient Ischemic Attack -A Single-arm Futility Study

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.

Study Overview

Detailed Description

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. RIC consisted of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on bilateral upper limbs twice a day. 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.

Study Type

Interventional

Enrollment (Actual)

167

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Beijing
      • Beijing, Beijing, China, 100053
        • Xuanwu Hospital, Capital Medical University
    • Hainan
      • Haikou, Hainan, China, 570102
        • First Affiliated Hospital of Hainan Medical University
    • Hunan
      • Changde, Hunan, China
        • Taoyuan People's Hospital
    • Shandong
      • Dongying, Shandong, China, 257034
        • Shengli Oilfield Center Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Eighteen years old or older of any gender or race;
  2. Diagnosed with a non-cardiogenic MIS/TIA within 14 days; MIS is defined by an ischemic stroke of score of 3 or less on the NIHSS at the time of inclusion, TIA is defined as neurologic deficit attributed to focal brain ischemia, with symptoms resolution within 24 h of symptom onset, Symptom onset is defined by the "last see normal" principle;
  3. Stable vital signs, normal cardiac, hepatic and renal functions;
  4. Able to consent by himself/herself or by legally authorized representative.

Exclusion Criteria:

  1. Diagnosis of hemorrhage or other pathology, such as vascular malformation, tumor, abscess or other non-vascular diseases, based on brain CT or MRI;
  2. Modified Rankin Scale score > 2 at inclusion;
  3. Received iv. recombinant tissue plasminogen activator (rtPA) therapy or interventional treatment for the current event;
  4. Contradiction for aspirin or clopidogrel (known allergy, severe asthma or heart failure et al.) ;
  5. Clear indication for anticoagulation therapy ( cardiac source of embolus);
  6. Hemorrhagic tendency of any reason (including but not limit to Hemostatic disorder, platelet count <100 × 109/L, history of drug-induced hepatic dysfunction);
  7. Any hemorrhagic transformation;
  8. Gastrointestinal bleed or major surgery within 3 months of symptoms onset;
  9. Stroke or TIA induced by interventional therapy or surgery;
  10. Any upper extremity soft tissue, vascular injury or peripheral blood vessel disease which may contraindicate RIC;
  11. Systolic blood pressure greater than 200 mmHg after medication;
  12. Planned revascularization (any angioplasty or vascular surgery) within the next 3 months ;
  13. Scheduled for surgery or interventional treatment requiring RIC cessation within next 3 months;
  14. Severe noncardiovascular comorbidity with life expectancy < 3 months;
  15. Pregnancy;
  16. Currently receiving an investigational drug or device by other studies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Remote Ischemic Conditioning
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrent rate of ischemic stroke/transient ischemic stroke
Time Frame: within 3 months
within 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment-Related Adverse Events
Time Frame: within 3 months
pain and tolerability, redness, bleeding, palpitation
within 3 months
Compliance of remote ischemic conditioning
Time Frame: within 3 months
the proportion of patients fulfill the treatment
within 3 months
Incidence rate of vascular events
Time Frame: within 3 months
hemorrhage stroke, myocardial infarction and vascular death
within 3 months
Improvements in NIH Stroke Scale
Time Frame: within1, 3 months
improvements in NIH Stroke Scale in patients without recurrence or vascular events
within1, 3 months
Improvements in modified Rankin Scale
Time Frame: within 1, 3 months
improvements in modified Rankin Scale Scale in patients without recurrence or vascular events
within 1, 3 months
Improvements in Barthel Scale
Time Frame: within 1,3 months
improvements in Barthel Scale in patients without recurrence or vascular events
within 1,3 months

Other Outcome Measures

Outcome Measure
Time Frame
Recurrent rate of ischemic stroke/transient ischemic stroke within 1 months
Time Frame: within 1 months
within 1 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Xunming Ji, MD, PhD, Xuanwu Hospital, Beijing
  • Study Director: Wuwei Feng, MD, MS, Medical University of South Carolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2016

Primary Completion (Actual)

October 19, 2017

Study Completion (Actual)

October 19, 2017

Study Registration Dates

First Submitted

December 10, 2016

First Submitted That Met QC Criteria

December 23, 2016

First Posted (Estimate)

December 29, 2016

Study Record Updates

Last Update Posted (Actual)

January 31, 2018

Last Update Submitted That Met QC Criteria

January 29, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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