Feasibility, Safety and Efficacy of Remote Ischemic Preconditioning for Symptomatic Intracranial Arterial Stenosis in Octogenarians

Intracranial Arterial Stenosis Clinical Trial

Official title:

Feasibility, Safety and Efficacy of RIPC for Symptomatic Intracranial Arterial Stenosis in Octogenarians

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01570231
• Other study ID #: 2009
• Status: Completed
• Phase: Phase 1
• First received: March 25, 2012
• Last updated: July 26, 2012
• Start date: January 2008
• Est. completion date: December 2010

Study information

• Verified date: July 2012
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Making a limb transiently ischemic induces ischemic tolerance in distant organs such as the heart. This study aims to evaluate the feasibility, safety and initial efficacy of using briefly repetitive bilateral limb ischemic preconditioning (BLIPC) to protect the brain in octogenarians with symptomatic intracranial arterial stenosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 80 Years to 95 Years

Eligibility

Inclusion Criteria:

1. age between 80 to 95 years old

2. Trial of Org 10172 in Acute Stroke Treatment-1 (TOAST-1) subtype

3. National Institutes of Health Stroke Scale (NIHSS) score 0-15, and Modified Rankin Scale (mRS) score 0-4

4. ABCD2 score between 6 to 7

5. stable vital signs, normal hepatic and renal functions

6. no hemorrhagic tendencies

Exclusion Criteria:

1. within 72 hrs of intra-artery or intravenous thrombolysis

2. intracranial hemorrhage or large area of cerebral infarction (more than 1/3 middle cerebral artery perfusion territory)

3. any soft tissue, orthopedic, or vascular injury, wounds or fractures in extremities which may pose a contraindication for application of the preconditioning cuffs

4. acute myocardial infarction

5. systolic blood pressure more than 200 mmHg after drug control

6. peripheral blood vessel disease

7. hematologic disease

8. severe hepatic and renal dysfunction

9. severe or unstable concomitant disease

10. cannot tolerate BLIPC or without informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bilateral Limb Ischemic Preconditioning
• Constriction, Pathologic
• Intracranial Arterial Stenosis
• Ischemia

Intervention

Device:
• bilateral limb ischemic preconditioning (Doctormate, IPC-906X)
Device: bilateral limb ischemic preconditioning (Doctormate, IPC-906X, produced by Beijing Renqiao Institute of Neuroscience)five cycles of 5 minutes bilateral upper limb ischemia-reperfusion performed by inflating tourniquets to 200 mmHg, twice daily for 180 consecutive days, along with conventional medical treatment.

Locations

Country	Name	City	State
China	Capital Medical University	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Ji Xunming	Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	objective signs of tissue or neurovascular injury	objective signs of tissue or neurovascular injury felt to be due to cuff inflation, which was based on the judgment of the observers (blinded to study protocol) precluded continuation. Inspection included palpation of distal radial pulses, visual inspection (for local edema, redness, skin breakdown), and palpation for tenderness	180 days after treatment	Yes
Primary	levels of plasma biomarkers	levels of plasma myoglobin at baseline and at the 1st, 15th and 30th day during BLIPC treatment were monitored	180-day	Yes