Rt-PA Thrombolytic Therapy in Combination With Remote Ischemic Conditioning for Acute Ischemic Stroke

NCT03231384 | Completed

• 1 other identifier: RIC/rtPA
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the safety and feasibility of remote limb ischemic conditioning(RIC) in acute ischemic stroke patients who received r-tPA thrombolytic therapy.

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Feasibility of RIC after acute ischemic stroke

  The proportion of enrolled subjects that completed all the designed RIC procedures.

  7 days

Secondary Outcomes (14)

• Objective signs of tissue or neurovascular injury

  within 7(±24h) days

• Number of participants with intracranial hemorrhage in two groups

  7(±24h)days

• Scores assessed by National Institutes of Health Stroke Scale(NIHSS)

  7(±24h)days

• The functional outcome at 90 days assessed by modified Rankin scale (mRS).

  90( ±7days) days

• functional outcome assessed by Barthel Index(BI)

  90( ±7days)days

Study Arms (2)

RIC group

EXPERIMENTAL

The upper limb ischemic conditioning is composed of five cycles of upper limb ischemia intervened by reperfusion, which is induced by two cuff placed around the upper arms respectively and inflated to 200 mm Hg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation. This therapy started within 2 hours after r-tPA thrombolytic therapy. In addition, all participants receive a standard clinical therapy.

Device: Remote ischemic conditioning

Control group

NO INTERVENTION

The participants received r-tPA thrombolytic therapy after diagnosed ischemic stroke. In addition, all participants receive a standard clinical therapy.

Interventions

Remote ischemic conditioning DEVICE

In this study, the remote ischemic conditioning treatment was composed of five cycles of bilateral upper limb ischemia intervened by reperfusion, which was induced by two cuff placed around the upper arms respectively and inflated to 200 mm Hg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation. Doctormate, IPC-906

RIC group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age≥18;
• Acute ischemic stroke;
• modified Rankin Scale (mRS) score of 2-5;
• mRS score less than 1 before onset of stroke symptom;
• Onset of stroke symptoms within 4.5h before initiation of intravenous rt-PA thrombolytic therapy;
• Good compliance for Remote Ischemic Conditioning(RIC) therapy;
• Informed consent obtained.

You may not qualify if:

• Stroke or serious head trauma within the previous 3 months
• Major surgery or severe trauma with in the preceding 3 months
• Intracranial hemorrhage
• Systolic pressure greater than 185 mm Hg or diastolic pressure greater than 110 mm Hg, or aggressive treatment intravenous medication) necessary to reduce blood pressure to these limits
• Symptoms rapidly improving
• Symptoms suggestive of subarachnoid hemorrhage, even if CT scan was normal
• Gastrointestinal hemorrhage or urinary tract hemorrhage within the previous 21 days
• Arterial puncture at a noncompressible site within the previous 7 days
• Seizure at the onset of stroke
• Platelet count of less than 100,000 per cubic millimeter
• Received heparin within the 48 hours preceding the onset of stroke and had an elevated partial-thromboplastin time
• Received oral anticoagulation therapy preceding the onset of stroke and INR greater than 1.7 or prothrombin times greater than 15 seconds
• CT showed a multiple infarction (low density area greater than 1/3 cerebral hemisphere)
• Use or plan to use intervention for diagnosis or treating
• Intracranial neoplasm, cerebral aneurysm or arteriovenous malformation

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, XI Cheng District, 100053, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: July 5, 2017
• First Posted: July 27, 2017
• Study Start: August 10, 2017
• Primary Completion: October 30, 2017
• Study Completion: February 14, 2018
• Last Updated: March 27, 2018

Record last verified: 2018-03

Locations

CN (1)