Cerebrovascular Disease
Conditions
Keywords
ischemic cerebral vascular disease, stroke secondary prevention, remote ischemic preconditioning
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.
Interventions
PROCEDURERemote 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.
Sponsors
National Natural Science Foundation of China
Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure and Heart Rates; | at the time points of baseline and 1, 15 and 30 days after BLIPC treatment | — |
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 51 |
| Stroke Secondary Prevention Procedure:stroke secondary prevention | 52 |
| Total | 103 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 11 |
| Overall Study | Protocol Violation | 4 | 7 |
| Overall Study | Withdrawal by Subject | 5 | 4 |
Baseline characteristics
| Characteristic | Stroke Secondary Prevention | RIPC+Stroke Secondary Prevension | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 20 Participants | 20 Participants | 40 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants | 31 Participants | 63 Participants |
| Age Continuous | 60 years STANDARD_DEVIATION 9.4 | 61 years STANDARD_DEVIATION 10.1 | 60.5 years STANDARD_DEVIATION 9.7 |
| Region of Enrollment China | 52 participants | 51 participants | 103 participants |
| Sex: Female, Male Female | 22 Participants | 21 Participants | 43 Participants |
| Sex: Female, Male Male | 30 Participants | 30 Participants | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 51 | 0 / 52 |
| serious Total, serious adverse events | 0 / 51 | 0 / 52 |
Outcome results
Primary
Blood Pressure and Heart Rates;
Time frame: at the time points of baseline and 1, 15 and 30 days after BLIPC treatment
Primary
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)
Time frame: 300 days after treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RIPC+Stroke Secondary Prevension | Number of Patients Who Got New Brain Lesions | 3 participants |
| Stroke Secondary Prevention | Number of Patients Who Got New Brain Lesions | 8 participants |
p-value: <0.05Log Rank
Primary
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
Time frame: the time points of baseline and 1, 15 and 30 days after BLIPC treatment
Secondary
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.
Time frame: 300-day after treatment
Secondary
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.
Time frame: At the 300-day after the initial treatment