Back to results

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

Primary Purpose

Cerebrovascular Disease

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Remote ischemic preconditioning (RIPC)

About this trial

This is an interventional prevention trial for Cerebrovascular Disease focused on measuring ischemic cerebral vascular disease, stroke secondary prevention, remote ischemic preconditioning

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

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)
Age between 18 to 80 years old
Trial of Org 10172 in Acute Stroke Treatment-1 (TOAST-1) subtype
National Institutes of Health Stroke Scale (NIHSS) score 0-15, and Modified Rankin Scale (mRS) score 0-4.
ABCD2 score between 6 to 7
Stable vital signs, normal hepatic and renal functions,
No hemorrhagic tendencies.

Exclusion criteria:

Within 72 hrs of intra-artery or intravenous thrombolysis
Intracranial hemorrhage or large area of cerebral infarction (more than 1/3 middle cerebral artery perfusion territory)
Any soft tissue, orthopedic, or vascular injury, wounds or fractures in extremities which may pose a contraindication for application of the preconditioning cuffs
Acute myocardial infarction
Systolic blood pressure more than 200 mmHg after drug control
Peripheral blood vessel disease
Hematologic disease
Severe hepatic and renal dysfunction
Severe or unstable concomitant disease
Cannot tolerate BLIPC or without informed consent
Patients who did not complete the whole treatment procedure.

Sites / Locations

Xuanwu Hospital, Capital Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

RIPC+stroke secondary prevension

stroke secondary prevention

Arm 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)

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

Outcomes

Primary Outcome Measures

Blood Pressure and Heart Rates;

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

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)

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT01321749

First Posted

March 23, 2011

Last Updated

March 30, 2012

Sponsor

Capital Medical University

Collaborators

National Natural Science Foundation of China

1. Study Identification

Unique Protocol Identification Number

NCT01321749

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Completed

Study Start Date

January 2008 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Capital Medical University

Collaborators

National Natural Science Foundation of China

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebrovascular Disease

Keywords

ischemic cerebral vascular disease, stroke secondary prevention, remote ischemic preconditioning

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

196 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RIPC+stroke secondary prevension

Arm Type

Experimental

Arm Description

Arm Title

stroke secondary prevention

Arm Type

No Intervention

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Remote ischemic preconditioning (RIPC)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Blood Pressure and Heart Rates;

Time Frame

at the time points of baseline and 1, 15 and 30 days after BLIPC treatment

Title

Plasma Biomarkers of Coagulation and Fibrinolysis

Description

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

Time Frame

the time points of baseline and 1, 15 and 30 days after BLIPC treatment

Title

Number of Patients Who Got New Brain Lesions

Description

We compared the number of patients who got new lesions in the Diffusion-weighted magnetic resonance imaging (DWI-MRI)

Time Frame

300 days after treatment

Secondary Outcome Measure Information:

Title

The Time Point Until the First Stroke Recurrence,

Description

These patients underwent MRI/DWI at the time of first recurrence; patients without symptoms recurrence underwent follow-up MRI/DWI at 300 days.

Time Frame

At the 300-day after the initial treatment

Title

Brain Perfusion Improvement Are Evaluated With SPECT and TCD

Description

Time Frame

300-day after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: 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) Age between 18 to 80 years old Trial of Org 10172 in Acute Stroke Treatment-1 (TOAST-1) subtype National Institutes of Health Stroke Scale (NIHSS) score 0-15, and Modified Rankin Scale (mRS) score 0-4. ABCD2 score between 6 to 7 Stable vital signs, normal hepatic and renal functions, No hemorrhagic tendencies. Exclusion criteria: Within 72 hrs of intra-artery or intravenous thrombolysis Intracranial hemorrhage or large area of cerebral infarction (more than 1/3 middle cerebral artery perfusion territory) Any soft tissue, orthopedic, or vascular injury, wounds or fractures in extremities which may pose a contraindication for application of the preconditioning cuffs Acute myocardial infarction Systolic blood pressure more than 200 mmHg after drug control Peripheral blood vessel disease Hematologic disease Severe hepatic and renal dysfunction Severe or unstable concomitant disease Cannot tolerate BLIPC or without informed consent Patients who did not complete the whole treatment procedure.

Facility Information:

Facility Name

Xuanwu Hospital, Capital Medical University

City

Xicheng District

State/Province

Beijing P.R.

ZIP/Postal Code

100053

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs