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

NCT ID: NCT01321749

Last Updated: 2012-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 196 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31

Brief 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.

Conditions

Cerebrovascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

RIPC+stroke secondary prevension

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)

Group Type: EXPERIMENTAL

Remote ischemic preconditioning (RIPC)

Intervention Type: PROCEDURE

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.

stroke secondary prevention

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Natural Science Foundation of China

OTHER_GOV

Sponsor Role: collaborator

Capital Medical University

OTHER

Sponsor Role: lead

Responsible Party

Ji Xunming

Xuan Wu Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Xuanwu Hospital, Capital Medical University

Xicheng District, Beijing P.R., China

Countries

China

Other Identifiers

RIPC2011

Identifier Type: -

Identifier Source: org_study_id