Improving Tolerance to Low Blood Flow to Brain in Patients with Stroke with manual Blood Pressure Machine

Phase 2

Completed

• Conditions: Health Condition 1: I639- Cerebral infarction, unspecifiedHealth Condition 2: null- Ischaemic stroke patients presenting within first 48 hours

• Registration Number: CTRI/2016/11/007495
• Lead Sponsor: Wellcome Trust and DBT Indian Alliance

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-11-30
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 57

Inclusion Criteria

1. TIA or ischaemic stroke.

2. Mild-to-moderate neurological deficits (NIHSS) 0 to15

3. Must have a diffusion-restricted lesion on MRI prior to enrolment

4. Presence of at least one vascular risk factor: hypertension, diabetes mellitus, dyslipidemia, smoking, coronary artery disease, non-valvular atrial fibrillation, symptomatic intracranial or extracranial atherosclerosis disease and rheumatic heart disease.

5. Must have infarct size more than 70 ml in the supratentorial region on DWI (the infarct volume will be measured at the time of enrolment by ABC/2 method)

6. Both anterior and posterior circulation stroke syndrome are eligible. Low risk of bleed such as meningiomas,arteriovenous malformations and cavernomas may be included at the discretion of the investigator.

Exclusion Criteria

1. Patients with premorbid disability (modified Rankin Scale greeter than 2)

2. Patients with unstable blood pressure (BP) and systolic BP 90 or 220 mmHg

3. Patients with ongoing symptomatic arrhthymia

4. Patients with contraindications to MRI including metallic implants

5 .Patients with any past sensitivity to iodinated contrast media will be eligible, but will not undergo CT perfusion or CT angiography

6. Patients deemed, as attending physician, unsuitable for RIC therapy due to local limb injury or bleeding risk

7. Patients who underwent thrombolysis and intra-arterial therapy will be eligible if the follow up CT scan at 36 hours has not demonstrated any parenchymal hematoma.

8. Patients with MRI demonstrated additional pathology including tumors or abscess. Individuals with small incidental lesions, at low risk of bleed such as meningiomas arteriovenous malformations and cavernomas maybe included at the discretion of the investigator

9. Pregnant and lactating women

10. Co-morbid illness with expected life expectancy less1 year.

11. Patients having stroke due to primary or secondary vasculitis syndrome

12. Patients with hereditary diseases like CADASIL, Fabryâ??s disease, Marfanâ??s syndrome, mitochondrial cytopathy

13. Patients with history of atherosclerotic or non-atherosclerotic peripheral vascular disease of upper limb, upper limb vascular bypass surgery or upper deep venous thrombosis.

14. Patients with history of systemic autoimmune disorder

15. Patients with easily bruising tendencies will be excluded, however patients on short-term or long-term anticoagulants will be included if they donâ??t bruise easily. Patients unlikely to be compliant with RIC therapy for 12 weeks

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and feasibility of RIC therapyTimepoint: 12 weeks

Secondary Outcome Measures

Name	Time	Method
1.Absolute and relative infarct growth at 1 week and 12 weeks. <br/ ><br>2.Endothelial function change (resting ABI and ED-FMD)at 1 week and 12 weeks. <br/ ><br>3.Affected hemisphere cerebral blood flow change (CTP) at 1 week and 12 weeks. <br/ ><br>Timepoint: 1 week and 12 weeks