Trial Outcomes & Findings for The Neuroprotective Effect of Remote Ischemic Preconditioning on Ischemic Cerebral Vascular Disease (NCT NCT01321749)

NCT ID: NCT01321749

Last Updated: 2012-04-25

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 196 participants
• Primary outcome timeframe: at the time points of baseline and 1, 15 and 30 days after BLIPC treatment
• Results posted on: 2012-04-25

Participant Flow

Participant milestones

Measure	RIPC+Stroke Secondary Prevension 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	Stroke Secondary Prevention Procedure:stroke secondary prevention
Overall Study STARTED	51	52
Overall Study COMPLETED	38	30
Overall Study NOT COMPLETED	13	22

Reasons for withdrawal

Measure	RIPC+Stroke Secondary Prevension 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	Stroke Secondary Prevention Procedure:stroke secondary prevention
Overall Study Lost to Follow-up	4	11
Overall Study Protocol Violation	4	7
Overall Study Withdrawal by Subject	5	4

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	RIPC+Stroke Secondary Prevension n=51 Participants 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	Stroke Secondary Prevention n=52 Participants Procedure:stroke secondary prevention	Total n=103 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=5 Participants	32 Participants n=7 Participants	63 Participants n=5 Participants
Age, Categorical >=65 years	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Age Continuous	61 years STANDARD_DEVIATION 10.1 • n=5 Participants	60 years STANDARD_DEVIATION 9.4 • n=7 Participants	60.5 years STANDARD_DEVIATION 9.7 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	22 Participants n=7 Participants	43 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Region of Enrollment China	51 participants n=5 Participants	52 participants n=7 Participants	103 participants n=5 Participants

PRIMARY outcome

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 300 days after treatment

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

Outcome measures

Measure	RIPC+Stroke Secondary Prevension n=38 Participants 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	Stroke Secondary Prevention n=30 Participants Procedure:stroke secondary prevention
Number of Patients Who Got New Brain Lesions	3 participants	8 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

RIPC+Stroke Secondary Prevension

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Stroke Secondary Prevention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	RIPC+Stroke Secondary Prevension n=51 participants at risk 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	Stroke Secondary Prevention n=52 participants at risk Procedure:stroke secondary prevention
Skin and subcutaneous tissue disorders transient sporadic subcutaneous bleeding points	5.9% 3/51 • Number of events 3	0.00% 0/52

Additional Information

Xunming Ji, M.D.,Ph.D.

XuanWu Hospital, Capital Medical University

Phone: 8683198127

Email: jixm70@hotmail.com , Jixm@ccmu.edu.cn

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place