NCT02886390

Brief Summary

to detect the efficiency and safety of intravenous rtPA combined with RIPC in acute ischemic stroke patients

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 1, 2016

Completed
1.8 years until next milestone

Study Start

First participant enrolled

June 16, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

June 20, 2018

Status Verified

June 1, 2018

Enrollment Period

8 months

First QC Date

August 28, 2016

Last Update Submit

June 19, 2018

Conditions

Stroke, Acute

Keywords

remote ischemic conditioningr-tPA thrombolytic therapy

Outcome Measures

Primary Outcomes (1)

  • infarction volume in brain between two groups

    assess by MRI-DWI and ADC

    measured during 72 h

Secondary Outcomes (18)

  • The score of Modified Rankin scale score

    measured at baseline(before RIPC),24 hours, at 5-7 days,30±7 days, 90±7 days

  • proportional of Modified Rankin scale scored 0-1

    measured at baseline(before RIPC),24 hours, at 5-7 days,30±7 days, 90±7 days

  • The score of National Institute of Health stroke scale score

    measured at baseline(before RIPC),24 hours, at 5-7 days,30±7 days, 90±7 days

  • The score of Barthel Index(BI)

    measured at baseline(before RIPC),24 hours, at 5-7 days,30±7 days, 90±7 days

  • recurrence of stroke and TIA

    changes from baseline(before RIPC) to 90±7 days

  • +13 more secondary outcomes

Study Arms (2)

RIC group

EXPERIMENTAL

The upper limb ischemic conditioning is composed of five cycles of bilateral 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: 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

ischemic conditioningDEVICE

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.

Also known as: Doctormate, IPC-906
RIC group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, age≥18;
  • Clinical sign and symptoms consistent with the diagnosis of an acute ischemic stroke, onset of stroke symptoms within 4.5 h before initiation of intravenous rt-PA thrombolytic therapy;
  • Baseline National Institutes of Health Stroke Scale (NIHSS) score of 4-15 (assessed before intravenous alteplase), mRS ≤1 before onset of stroke symptom;
  • No contraindication for MRI.
  • Informed consent obtained

You may not qualify if:

  • Cardioembolism；
  • Contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs;
  • Life expectancy \< 1 year;
  • Pregnant or breast-feeding women;
  • Unwilling to be followed up or poor compliance for treatment; (5) Patients being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

Lu He hospital, Capital Medical University

Beijing, Beijing Municipality, 101149, China

NOT YET RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Xunming Ji, MD. PhD

    Xuanwu Hospital, Beijing

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xunming Ji, MD. PhD

CONTACT

+86-10-83198952jixm@ccmu.edu.cn

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

August 28, 2016

First Posted

September 1, 2016

Study Start

June 16, 2018

Primary Completion

February 1, 2019

Study Completion

May 1, 2019

Last Updated

June 20, 2018

Record last verified: 2018-06

Locations

CN(2)