The Neuroprotective Effect of Remote Ischemic Preconditioning on Ischemic Cerebral Vascular Disease

Cerebrovascular Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01321749
• Other study ID #: RIPC2011
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 23, 2011
• Last updated: March 30, 2012
• Start date: January 2008

Study information

• Verified date: March 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

This study is a prospective, randomized, single-center trial, designed to observe the effect of remote limb ischemic preconditioning on ischemic cerebral vascular disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion criteria:

1. Patients with stroke or transient ischemic attack (TIA) within 180 days and the neurologic deficits were well matched to the territory of the stenosed artery, with intracranial arterial stenosis of at least 50% by angiography, at least 70% by ultrasound, or at least 70% by computed tomographic angiography (CTA) or magnetic resonance angiography (MRA)

2. Age between 18 to 80 years old

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

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

5. ABCD2 score between 6 to 7

6. Stable vital signs, normal hepatic and renal functions,

7. 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

11. Patients who did not complete the whole treatment procedure.

Study Design

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

Related Conditions & MeSH terms

• Cerebrovascular Disease
• Cerebrovascular Disorders
• Vascular Diseases

Intervention

Procedure:
• Remote ischemic preconditioning (RIPC)
The detail of RIPC included five cycles of bilateral upper limbs 5/5 min. of ischemia and reperfusion alternation. Limb ischemia was induced by inflating tourniquets to 200 mmHg. This process was placed on both arms every day.

Locations

Country	Name	City	State
China	Xuanwu Hospital, Capital Medical University	Xicheng District	Beijing P.R.

Sponsors (2)

Lead Sponsor	Collaborator
Capital Medical University	National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure and Heart Rates;		at the time points of baseline and 1, 15 and 30 days after BLIPC treatment	Yes
Primary	Plasma Biomarkers of Coagulation and Fibrinolysis	blood samples were collected one hour after every times of BLIPC procedure ended, and assayed with the immuno-turbidimetry assay on the coagulation laboratory autoanalyzer	the time points of baseline and 1, 15 and 30 days after BLIPC treatment	Yes
Primary	Number of Patients Who Got New Brain Lesions	We compared the number of patients who got new lesions in the Diffusion-weighted magnetic resonance imaging (DWI-MRI)	300 days after treatment	Yes
Secondary	The Time Point Until the First Stroke Recurrence,	These patients underwent MRI/DWI at the time of first recurrence; patients without symptoms recurrence underwent follow-up MRI/DWI at 300 days.	At the 300-day after the initial treatment	Yes
Secondary	Brain Perfusion Improvement Are Evaluated With SPECT and TCD	Brain perfusion status were evalvated by SPECT SPECT scanning was performed using a dual headed rotating gamma camera at 30 minutes after intravenous 99mTc-ECD (25mCi) bolus injection and at 40 minutes after 18F -FDG bolus injection.	300-day after treatment	Yes