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

Capital Medical University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Cerebrovascular Disease

Treatments: Procedure: Remote ischemic preconditioning (RIPC)

Study type: Interventional

Funder types: Other

Identifiers

NCT01321749

RIPC2011

Details and patient eligibility

About

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

Enrollment: 196 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

196 participants in 2 patient groups

RIPC+stroke secondary prevension

Experimental group

Description:

Procedure/Surgery: 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. Procedure:stroke secondary prevention(Such as Antiplatelet therapy, Cholesterol-lowering therapymaintain blood pressure and blood sugar normal)

Treatment:

Procedure: Remote ischemic preconditioning (RIPC)

stroke secondary prevention

No Intervention group

Description:

Procedure:stroke secondary prevention(Such as Antiplatelet therapy, Cholesterol-lowering therapymaintain blood pressure and blood sugar normal)