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Completed

NCT Number: NCT03231384

Rt-PA Thrombolytic Therapy in Combination With Remote Ischemic Conditioning for Acute Ischemic Stroke

The purpose of this study is to determine the safety and feasibility of remote limb ischemic conditioning(RIC) in acute ischemic stroke patients who received r-tPA thrombolytic therapy.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xuanwu Hospital, Capital Medical University

Beijing, XI Cheng District, 100053, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female, age≥18;
  • Acute ischemic stroke;
  • modified Rankin Scale (mRS) score of 2-5;
  • mRS score less than 1 before onset of stroke symptom;
  • Onset of stroke symptoms within 4.5h before initiation of intravenous rt-PA thrombolytic therapy;
  • Good compliance for Remote Ischemic Conditioning(RIC) therapy;
  • Informed consent obtained.

Exclusion criteria

  • Stroke or serious head trauma within the previous 3 months
  • Major surgery or severe trauma with in the preceding 3 months
  • Intracranial hemorrhage
  • Systolic pressure greater than 185 mm Hg or diastolic pressure greater than 110 mm Hg, or aggressive treatment intravenous medication) necessary to reduce blood pressure to these limits
  • Symptoms rapidly improving
  • Symptoms suggestive of subarachnoid hemorrhage, even if CT scan was normal
  • Gastrointestinal hemorrhage or urinary tract hemorrhage within the previous 21 days
  • Arterial puncture at a noncompressible site within the previous 7 days
  • Seizure at the onset of stroke
  • Platelet count of less than 100,000 per cubic millimeter
  • Received heparin within the 48 hours preceding the onset of stroke and had an elevated partial-thromboplastin time
  • Received oral anticoagulation therapy preceding the onset of stroke and INR greater than 1.7 or prothrombin times greater than 15 seconds
  • CT showed a multiple infarction (low density area greater than 1/3 cerebral hemisphere)
  • Use or plan to use intervention for diagnosis or treating
  • Intracranial neoplasm, cerebral aneurysm or arteriovenous malformation
  • severe hepatic or renal dysfunction
  • Contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs.
  • Life expectancy<1 years
  • Pregnant or breast-feeding women
  • Unwilling to be followed up or poor compliance for treatment
  • Patients being enrolled or having been enrolled

Treatment and study plan

remote ischemic conditioning

Device

In this study, the remote ischemic conditioning treatment was composed of five cycles of bilateral upper limb ischemia intervened by reperfusion, which was induced by two cuff placed around the upper arms respectively and inflated to 200 mm Hg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation.

Doctormate, IPC-906

Primary outcomes

  1. Feasibility of RIC after acute ischemic stroke

    Time frame: 7 days

    The proportion of enrolled subjects that completed all the designed RIC procedures.

Secondary outcomes

  1. Objective signs of tissue or neurovascular injury

    Time frame: within 7(±24h) days

    objective signs of tissue or neurovascular injury felt to be due to cuff inflation. Inspection included palpation of distal radial pulses, visual inspection (for local edema, redness, skin breakdown), and palpation for tenderness

  2. Number of participants with intracranial hemorrhage in two groups

    Time frame: 7(±24h)days

  3. Scores assessed by National Institutes of Health Stroke Scale(NIHSS)

    Time frame: 7(±24h)days

  4. The functional outcome at 90 days assessed by modified Rankin scale (mRS).

    Time frame: 90( ±7days) days

  5. functional outcome assessed by Barthel Index(BI)

    Time frame: 90( ±7days)days

  6. cerebral infarct volume.

    Time frame: 3-7 days after stroke onset

    The infarct volume of cerebral infarct is evaluated by cranial noncontrast MRI

  7. cerebral infarct volume.

    Time frame: 3-7 days after stroke onset

    The infarct volume of cerebral infarct is evaluated by cranial noncontrast CT

  8. Cardiovascular parameters during 7 days of RIC treatment.

    Time frame: 7 days

    the blood pressure were measured immediately before RIC and also be measured 5 minutes after RIC.

  9. the heart rate during 7 days of RIC treatment.

    Time frame: 7 days

    the heart rate were measured immediately before RIC and also be measured 5 minutes after RIC.

  10. Levels of plasma myoglobin

    Time frame: baseline and 7(±2)days

  11. Levels of serum IL-6

    Time frame: baseline and 7(±2)days

  12. Levels of serum HS-CRP

    Time frame: baseline and 7(±2)days

  13. Levels of serum HCY

    Time frame: baseline and 7(±2)days

  14. Any adverse events

    Time frame: 90(±7)days

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Official study title

Safety and Feasibility of Rt-PA Thrombolytic Therapy in Combination With Remote Ischemic Conditioning for Acute Ischemic Stroke(rtPA-RIC1)

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Jul 27, 2017
Registry last updated
Mar 27, 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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