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

• Sponsor: Capital Medical University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01321749
• Collaborator: National Natural Science Foundation of China (Other)
• Enrollment: 196
• Location: 1
• Arms: 2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebrovascular Disease	Procedure: Remote ischemic preconditioning (RIPC)	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 196 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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)	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.
No Intervention: stroke secondary prevention Procedure:stroke secondary prevention(Such as Antiplatelet therapy, Cholesterol-lowering therapymaintain blood pressure and blood sugar normal)

Outcome Measures

Primary Outcome Measures

1. Blood Pressure and Heart Rates; [at the time points of baseline and 1, 15 and 30 days after BLIPC treatment]

2. Plasma Biomarkers of Coagulation and Fibrinolysis [the time points of baseline and 1, 15 and 30 days after BLIPC treatment]

   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

3. Number of Patients Who Got New Brain Lesions [300 days after treatment]

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

Secondary Outcome Measures

1. The Time Point Until the First Stroke Recurrence, [At the 300-day after the initial treatment]

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

2. Brain Perfusion Improvement Are Evaluated With SPECT and TCD [300-day after treatment]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xuanwu Hospital, Capital Medical University	Xicheng District	Beijing P.R.	China	100053

Sponsors and Collaborators

• Capital Medical University
• National Natural Science Foundation of China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ji Xunming, Xuan Wu Hospital, Capital Medical University
• ClinicalTrials.gov Identifier: NCT01321749
• Other Study ID Numbers: RIPC2011
• First Posted: Mar 24, 2011
• Last Update Posted: Apr 25, 2012
• Last Verified: Mar 1, 2012

• Keywords provided by Ji Xunming, Xuan Wu Hospital, Capital Medical University: ischemic cerebral vascular disease; stroke secondary prevention; remote ischemic preconditioning
• Additional relevant MeSH terms: Cerebrovascular Disorders; Vascular Diseases

Study Results

Participant Flow

Arm/Group Title	RIPC+Stroke Secondary Prevension	Stroke Secondary Prevention
Arm/Group Description	Procedure/Surgery: 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	Procedure:stroke secondary prevention
Period Title: Overall Study
STARTED	51	52
COMPLETED	38	30
NOT COMPLETED	13	22

Baseline Characteristics

Arm/Group Title	RIPC+Stroke Secondary Prevension	Stroke Secondary Prevention	Total
Arm/Group Description	Procedure/Surgery: 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	Procedure:stroke secondary prevention	Total of all reporting groups
Overall Participants	51	52	103
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	31 60.8%	32 61.5%	63 61.2%
>=65 years	20 39.2%	20 38.5%	40 38.8%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61 (10.1)	60 (9.4)	60.5 (9.7)
Sex: Female, Male (Count of Participants)
Female	21 41.2%	22 42.3%	43 41.7%
Male	30 58.8%	30 57.7%	60 58.3%
Region of Enrollment (participants) [Number]
China	51 100%	52 100%	103 100%

Outcome Measures

1. Primary Outcome

Title	Blood Pressure and Heart Rates;
Time Frame	at the time points of baseline and 1, 15 and 30 days after BLIPC treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	RIPC+Stroke Secondary Prevension	Stroke Secondary Prevention
Arm/Group Description	Procedure/Surgery: 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	Procedure:stroke secondary prevention
Measure Participants	38	30
Number [participants]	3 5.9%	8 15.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	RIPC+Stroke Secondary Prevension, Stroke Secondary Prevention
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Log Rank
	Comments

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Brain Perfusion Improvement Are Evaluated With SPECT and TCD
Description	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.
Time Frame	300-day after treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	RIPC+Stroke Secondary Prevension		Stroke Secondary Prevention
Arm/Group Description	Procedure/Surgery: 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		Procedure:stroke secondary prevention
All Cause Mortality
	RIPC+Stroke Secondary Prevension		Stroke Secondary Prevention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	RIPC+Stroke Secondary Prevension		Stroke Secondary Prevention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/51 (0%)		0/52 (0%)
Other (Not Including Serious) Adverse Events
	RIPC+Stroke Secondary Prevension		Stroke Secondary Prevention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/51 (5.9%)		0/52 (0%)
Skin and subcutaneous tissue disorders
transient sporadic subcutaneous bleeding points	3/51 (5.9%)	3	0/52 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.