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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Feasibility of Applying Remote Ischemic Conditioning in Secondary Prevention in Patients With Minor Ischemic Stroke or Transient Ischemic Attack —A Single-arm Futili

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.

Detailed 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. 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.
Sponsor: Capital Medical University

Current Primary Outcome: Recurrent rate of ischemic stroke/transient ischemic stroke [ Time Frame: within 3 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Treatment-Related Adverse Events [ Time Frame: within 3, 6 and 12 months ]
    pain and tolerability, redness, bleeding, palpitation
  • Compliance of remote ischemic conditioning [ Time Frame: within 3, 6 and 12 months ]
    the proportion of patients fulfill the treatment
  • Incidence rate of vascular events [ Time Frame: within 3 months ]
    hemorrhage stroke, myocardial infarction and vascular death
  • Improvements in NIH Stroke Scale [ Time Frame: within 3, 6 and 12 months ]
    improvements in NIH Stroke Scale in patients without recurrence or vascular events
  • Improvements in modified Rankin Scale [ Time Frame: within 3, 6 and 12 months ]
    improvements in modified Rankin Scale Scale in patients without recurrence or vascular events
  • Improvements in Barthel Scale [ Time Frame: within 3, 6 and 12 months ]
    improvements in Barthel Scale in patients without recurrence or vascular events


Original Secondary Outcome: Same as current

Information By: Capital Medical University

Dates:
Date Received: December 10, 2016
Date Started: December 2016
Date Completion: August 2018
Last Updated: December 30, 2016
Last Verified: December 2016