Ischemic StrokeNCT03231384
Rt-PA Thrombolytic Therapy in Combination With Remote Ischemic Conditioning for Acute Ischemic Stroke
A study testing Remote ischemic conditioning in people with Ischemic Stroke, run by Capital Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Remote ischemic conditioning
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2017to 14 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 21Show fewer
- 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
- severe hepatic or renal dysfunction
- Contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs.
- Life expectancy<1 years
- Pregnant or breast-feeding women
- Unwilling to be followed up or poor compliance for treatment
- Patients being enrolled or having been enrolled
Trial locations and contacts
1 site in 1 country.
China1 site
Xuanwu Hospital, Capital Medical University
Beijing, XI Cheng District, 100053
About this study
Official title: Safety and Feasibility of Rt-PA Thrombolytic Therapy in Combination With Remote Ischemic Conditioning for Acute Ischemic Stroke(rtPA-RIC1)
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
- Being tested
- Remote ischemic conditioning
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote 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.
Doctormate, IPC-906
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of RIC after acute ischemic stroke
The proportion of enrolled subjects that completed all the designed RIC procedures.
Measured: 7 days
Secondary outcomes (14)
Objective signs of tissue or neurovascular injury
objective signs of tissue or neurovascular injury felt to be due to cuff inflation. Inspection included palpation of distal radial pulses, visual inspection (for local edema, redness, skin breakdown), and palpation for tenderness
Measured: within 7(±24h) days
Number of participants with intracranial hemorrhage in two groups
Measured: 7(±24h)days
Scores assessed by National Institutes of Health Stroke Scale(NIHSS)
Measured: 7(±24h)days
The functional outcome at 90 days assessed by modified Rankin scale (mRS).
Measured: 90( ±7days) days
functional outcome assessed by Barthel Index(BI)
Measured: 90( ±7days)days
cerebral infarct volume.
The infarct volume of cerebral infarct is evaluated by cranial noncontrast MRI
Measured: 3-7 days after stroke onset
cerebral infarct volume.
The infarct volume of cerebral infarct is evaluated by cranial noncontrast CT
Measured: 3-7 days after stroke onset
Cardiovascular parameters during 7 days of RIC treatment.
the blood pressure were measured immediately before RIC and also be measured 5 minutes after RIC.
Measured: 7 days
the heart rate during 7 days of RIC treatment.
the heart rate were measured immediately before RIC and also be measured 5 minutes after RIC.
Measured: 7 days
Levels of plasma myoglobin
Measured: baseline and 7(±2)days
Levels of serum IL-6
Measured: baseline and 7(±2)days
Levels of serum HS-CRP
Measured: baseline and 7(±2)days
Levels of serum HCY
Measured: baseline and 7(±2)days
Any adverse events
Measured: 90(±7)days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study start10 Aug 2017
- Primary completion30 Oct 2017
- Study completion14 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Xunming, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03231384
- Sponsor's protocol ID
- RIC/rtPA
- Status last verified
- Mar 2018
- First submitted
- 5 Jul 2017
- Last updated
- 27 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of Rt-PA Thrombolytic Therapy in Combination With Remote Ischemic Conditioning for Acute Ischemic Stroke(rtPA-RIC1)
- ClinicalTrials.gov ID
- NCT03231384
- Acronym / sponsor ID
- RIC/rtPA
- Conditions
- Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 10 Aug 2017 (actual)
- Primary completion
- 30 Oct 2017 (actual)
- Study completion
- 14 Feb 2018 (actual)
- First posted
- 27 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIC group | Experimental | Device: Remote ischemic conditioningThe 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. |
| Control group | No intervention | –The participants received r-tPA thrombolytic therapy after diagnosed ischemic stroke. In addition, all participants receive a standard clinical therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote ischemic conditioningIn 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 | Device | RIC group |
Primary outcome
Feasibility of RIC after acute ischemic stroke
Time frame: 7 days
The proportion of enrolled subjects that completed all the designed RIC procedures.
14 secondary outcomes
Objective signs of tissue or neurovascular injury
Time frame: within 7(±24h) days
Number of participants with intracranial hemorrhage in two groups
Time frame: 7(±24h)days
Scores assessed by National Institutes of Health Stroke Scale(NIHSS)
Time frame: 7(±24h)days
The functional outcome at 90 days assessed by modified Rankin scale (mRS).
Time frame: 90( ±7days) days
functional outcome assessed by Barthel Index(BI)
Time frame: 90( ±7days)days
cerebral infarct volume.
Time frame: 3-7 days after stroke onset
cerebral infarct volume.
Time frame: 3-7 days after stroke onset
Cardiovascular parameters during 7 days of RIC treatment.
Time frame: 7 days
the heart rate during 7 days of RIC treatment.
Time frame: 7 days
Levels of plasma myoglobin
Time frame: baseline and 7(±2)days
Levels of serum IL-6
Time frame: baseline and 7(±2)days
Levels of serum HS-CRP
Time frame: baseline and 7(±2)days
Levels of serum HCY
Time frame: baseline and 7(±2)days
Any adverse events
Time frame: 90(±7)days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote ischemic conditioning in people with Ischemic Stroke, run by Capital Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of RIC after acute ischemic stroke (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2018.