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

Completed

Phase N/A Results N/A

Trial 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. 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 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.

Conditions

Interventions

  • Remote Ischemic Conditioning Device
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Remote Ischemic Conditioning
    Description: 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.

Outcomes

Type Measure Time Frame Safety Issue
Primary Recurrent rate of ischemic stroke/transient ischemic stroke within 3 months
Secondary Treatment-Related Adverse Events within 3, 6 and 12 months
Secondary Compliance of remote ischemic conditioning within 3, 6 and 12 months
Secondary Incidence rate of vascular events within 3 months
Secondary Improvements in NIH Stroke Scale within 3, 6 and 12 months
Secondary Improvements in modified Rankin Scale within 3, 6 and 12 months
Secondary Improvements in Barthel Scale within 3, 6 and 12 months

Sponsors