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Completed

NCT Number: NCT03004820

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

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xuanwu Hospital, Capital Medical University, Beijing, Beijing Municipality, China

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About this 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. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Diagnosis of hemorrhage or other pathology, such as vascular malformation, tumor, abscess or other non-vascular diseases, based on brain CT or MRI;
  • Modified Rankin Scale score > 2 at inclusion;
  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Recurrent rate of ischemic stroke/transient ischemic stroke

    Time frame: within 3 months

Secondary outcomes

  1. Treatment-Related Adverse Events

    Time frame: within 3 months

    pain and tolerability, redness, bleeding, palpitation

  2. Compliance of remote ischemic conditioning

    Time frame: within 3 months

    the proportion of patients fulfill the treatment

  3. Incidence rate of vascular events

    Time frame: within 3 months

    hemorrhage stroke, myocardial infarction and vascular death

  4. Improvements in NIH Stroke Scale

    Time frame: within1, 3 months

    improvements in NIH Stroke Scale in patients without recurrence or vascular events

  5. Improvements in modified Rankin Scale

    Time frame: within 1, 3 months

    improvements in modified Rankin Scale Scale in patients without recurrence or vascular events

  6. Improvements in Barthel Scale

    Time frame: within 1,3 months

    improvements in Barthel Scale in patients without recurrence or vascular events

Other outcomes

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

    Time frame: within 1 months

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Official study title

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

Acronym: PICNIC-ONE

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 29, 2016
Registry last updated
Jan 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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