Intracranial AtherosclerosisPICASSONCT03208166
Pilot Study of Pre-Ischemic Conditioning for Intracranial Atherosclerosis
A study testing Doctormate in people with Intracranial Atherosclerosis, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of this study is to determine the effects of the Doctormate device, a specialized blood pressure cuff used to perform remote limb ischemic conditioning, on cerebral blood flow in subjects with intracranial atherosclerosis. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Intracranial Atherosclerosis
- What is being tested?
- Doctormate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2017to 30 May 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic cerebral infarction within 30 days of enrollment attributed to 70-99% stenosis of a major intracranial artery (carotid artery, MCA stem (M1), vertebral artery, or basilar artery) that is documented by any of the following: MRA, CTA, or catheter angiography. Percent stenosis will be measured according to WASID criteria (= 1 - [Ds / Dn]) x 100% with Ds [diameter of stenosis] and Dn [diameter of normal vessel]).19
- Modified Rankin score of ≤ 3
- Age ≥ 30 years and ≤ 90 years. Subjects 30-49 years are required to meet at least one additional criteria (i-vi) provided in the table below to qualify for the study. This additional requirement is to increase the likelihood that the symptomatic intracranial stenosis in subjects 30-49 years is atherosclerotic.
- i. insulin dependent diabetes for at least 15 years
- ii. at least 2 of the following atherosclerotic risk factors: hypertension (BP > 140/90 or on antihypertensive therapy); dyslipidemia (LDL > 130 mg /dl or HDL < 40 mg/dl or fasting triglycerides > 150 mg/dl or on lipid lowering therapy); smoking; non-insulin dependent diabetes or insulin dependent diabetes of less than 15 years duration; family history of any of the following: myocardial infarction, coronary artery bypass, coronary angioplasty or stenting, stroke, carotid endarterectomy or stenting, peripheral vascular surgery in parent or sibling who was < 55 years of age for men or < 65 for women at the time of the event
- iii. history of any of the following: myocardial infarction, coronary artery bypass, coronary angioplasty or stenting, carotid endarterectomy or stenting, or peripheral vascular surgery for atherosclerotic disease
Show all 15Show fewer
- iv. any stenosis of an extracranial carotid or vertebral artery, another intracranial artery, subclavian artery, coronary artery, iliac or femoral artery, other lower or upper extremity artery, mesenteric artery, or renal artery that was documented by non-invasive vascular imaging or catheter angiography and is considered atherosclerotic
- v. aortic arch atheroma documented by non-invasive vascular imaging or catheter angiography
- vi. any aortic aneurysm documented by non-invasive vascular imaging or catheter angiography that is considered atherosclerotic
- Recent (within 30 days) negative pregnancy test in a female who has had any menses in the last 12 months
- Subject is willing and able to return in 30 days for close-out visit for the study
- Subject is available by phone
- Subject is able to apply the conditioning device or has access to another person (family member, friend) who can assist with application of conditioning device if needed
- Subject understands the purpose and requirements of the study, can make him/herself understood, and has provided informed consent
- Subject is able to undergo brain MRI
Who cannot join
- Previous treatment of target lesion with a stent, angioplasty, or other mechanical device, or plan to perform one of these procedures
- Plan to perform concomitant angioplasty or stenting of an extracranial vessel tandem to an intracranial stenosis
- Intracranial tumor (except meningioma) or any intracranial vascular malformation
- Thrombolytic therapy within 24 hours prior to enrollment
- Progressive neurological signs within 24 hours prior to enrollment
- Any intracranial hemorrhage (parenchmal, subarachnoid, subdural, epidural) within 90 days
Show all 22Show fewer
- Any untreated chronic subdural hematoma
- Intracranial arterial stenosis due to arterial dissection, Moya Moya disease; any known vasculitic disease; herpes zoster, varicella zoster or other viral vasculopathy; neurosyphilis; any other intracranial infection; any intracranial stenosis associated with CSF pleocytosis; radiation induced vasculopathy; fibromuscular dysplasia; sickle cell disease; neurofibromatosis; benign angiopathy of central nervous system; post-partum angiopathy; suspected vasospastic process, suspected recanalized embolus
- Presence of any of the following unequivocal cardiac sources of embolism: chronic or paroxysmal atrial fibrillation, mitral stenosis, mechanical valve, endocarditis, intracardiac clot or vegetation, myocardial infarction within three months, dilated cardiomyopathy, left atrial spontaneous echo contrast, ejection fraction less than 30%
- History of upper extremity ischemia, known subclavian or brachial artery stenosis, subclavian steal syndrome, any upper extremity soft tissue, orthopedic or vascular injury, or mastectomy or other procedure that may contraindicate taking blood pressure or having a cuff on the arm for the conditioning treatment
- Difference in systolic blood pressure of > 15 mm Hg between both arms
- Known allergy to aspirin or clopidogrel
- Active peptic ulcer disease, major systemic hemorrhage within 30 days, active bleeding diathesis, platelets < 100,000, hematocrit < 30, INR > 1.5, clotting factor abnormality that increases the risk of bleeding, current alcohol or substance abuse, uncontrolled severe hypertension (systolic pressure > 180 mm Hg or diastolic pressure > 115 mm Hg), severe liver impairment (AST or ALT > 3 x normal, cirrhosis), subject on dialysis
- Major surgery (including open femoral, aortic, or carotid surgery, cardiac) within previous 30 days or planned in the next 30 days after enrollment
- Indication for warfarin or heparin beyond enrollment (NOTE: exceptions allowed for subcutaneous heparin for deep vein thrombosis (DVT) prophylaxis while hospitalized)
- Diabetic subjects taking sulfonylurea drugs
- Severe neurological deficit that renders the subject incapable of living independently
- Dementia or psychiatric problem that prevents the subject from following the protocol reliably
- Co-morbid conditions that may limit survival to less than 3 months
- Pregnancy or of childbearing potential and unwilling to use contraception for the duration of this study
- Claustrophobia requiring sedation for MRI
- Enrollment in another study that would conflict with the current study
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29403
About this study
The purpose of this study is to determine the effects of the Doctormate device, a specialized blood pressure cuff used to perform remote limb ischemic conditioning, on cerebral blood flow in subjects with intracranial atherosclerosis. Previous studies in patients with narrowing of the brain arteries have shown that this device is safe to use and suggested that if this device is inflated in both arms for 5 minutes, followed by deflation for 5 minutes and repeated 4 times in a row every day for 6-9 months, the risk of another stroke is lowered and the device may increase the blood flow to the brain.
Read the detailed description
In this prospective randomized pilot study, 10 eligible high-risk subjects with ICAS will be randomized to RLIC (bilateral upper extremity daily for 30 days) plus medical management (n=5) or medical management alone (n=5). The medical management, which is the standard of care, will be started at study enrollment and continued until close-out in all subjects. It will consist of aspirin 325 mg per day, clopidogrel 75 mg per day, and risk factor management primarily targeting a systolic BP < 140 mmHg and LDL cholesterol < 70 mg /dl.
All subjects will undergo baseline brain arterial spin labeling (ASL) and perfusion MRI to measure CBF and have blood drawn for biomarkers 3-5 days after randomization to allow for washout of any effect from the test RLIC treatment that will be done prior to randomization to determine the subjects' tolerability to RLIC treatment. The period of 3-5 days will provide flexibility for scheduling these tests. After the baseline MRI and biomarker tests are completed, the subjects randomized to RLIC will begin daily RLIC for 30 days. Each daily RLIC treatment will consist of 4 cycles of 5-minute inflations of both blood pressure cuffs simultaneously to a pressure of 200 mm Hg with 5 minutes of reperfusion between each inflation using the Doctormate device.
All subjects will return for their close-out visits 33-35 days after enrolling in the study and will undergo brain ASL and perfusion MRI and have blood drawn for biomarkers at that visit. The study will be conducted at 4 sites (MUSC, MCG, UCLA, USC) to enable us to evaluate the consistency of CBF measurements across multiple sites and to ensure that the recruitment target of 10 subjects will be met in time to allow for the subsequent NIH grant submission in 2017.
- Conditions
- Intracranial Atherosclerosis
- Being tested
- Doctormate, Usual Care
- Medical subject headings
- Intracranial Arteriosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoctormateDevice
Ischemic conditioning device
Usual CareOther
Standard medical care
| Study group | Role | What they receive |
|---|---|---|
| Ischemic Conditioning | Experimental | Doctormate device is used daily. Receives: Device: Doctormate; Other: Usual Care |
| Usual Care | Other | Standard medical care. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Cerebral Blood Flow (CBF)
Percent change CBF from baseline to 30 days as determined by ASL MRI imaging.
Measured: Baseline and 30 days
Change in Putative Blood Biomarkers
Change in the absolute levels of the following biomarkers will be measured from baseline to 30 days: Nitrite, IL-10, SDF1, Micro RNA 144. Lp-PLA2, IL-6. hsCRP, Soluble E selectin, ICAm, MMP-9, PAI-1,tPA, ADMA
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2017
- Study start15 Jun 2017
- Primary completion30 May 2018
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intracranial AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern California, University of California, Los Angeles, Augusta University
- Responsible party
- Sponsor
- Investigators
- Marc I Chimowitz, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03208166
- Sponsor's protocol ID
- Pro00062831
- Acronym
- PICASSO
- Status last verified
- Sep 2019
- First submitted
- 30 Jun 2017
- Last updated
- 7 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Pre-Ischemic Conditioning for Intracranial Atherosclerosis
- ClinicalTrials.gov ID
- NCT03208166
- Acronym / sponsor ID
- PICASSO / Pro00062831
- Conditions
- Intracranial Atherosclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- University of Southern California, University of California, Los Angeles, Augusta University
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 5 Jul 2017 (actual)
- Results
- Posted 7 Oct 2019
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 effects of the Doctormate device, a specialized blood pressure cuff used to perform remote limb ischemic conditioning, on cerebral blood flow in subjects with intracranial atherosclerosis. Previous studies in patients with narrowing of the brain arteries have shown that this device is safe to use and suggested that if this device is inflated in both arms for 5 minutes, followed by deflation for 5 minutes and repeated 4 times in a row every day for 6-9 months, the risk of another stroke is lowered and the device may increase the blood flow to the brain.
Detailed description
In this prospective randomized pilot study, 10 eligible high-risk subjects with ICAS will be randomized to RLIC (bilateral upper extremity daily for 30 days) plus medical management (n=5) or medical management alone (n=5). The medical management, which is the standard of care, will be started at study enrollment and continued until close-out in all subjects. It will consist of aspirin 325 mg per day, clopidogrel 75 mg per day, and risk factor management primarily targeting a systolic BP < 140 mmHg and LDL cholesterol < 70 mg /dl.
All subjects will undergo baseline brain arterial spin labeling (ASL) and perfusion MRI to measure CBF and have blood drawn for biomarkers 3-5 days after randomization to allow for washout of any effect from the test RLIC treatment that will be done prior to randomization to determine the subjects' tolerability to RLIC treatment. The period of 3-5 days will provide flexibility for scheduling these tests. After the baseline MRI and biomarker tests are completed, the subjects randomized to RLIC will begin daily RLIC for 30 days. Each daily RLIC treatment will consist of 4 cycles of 5-minute inflations of both blood pressure cuffs simultaneously to a pressure of 200 mm Hg with 5 minutes of reperfusion between each inflation using the Doctormate device.
All subjects will return for their close-out visits 33-35 days after enrolling in the study and will undergo brain ASL and perfusion MRI and have blood drawn for biomarkers at that visit. The study will be conducted at 4 sites (MUSC, MCG, UCLA, USC) to enable us to evaluate the consistency of CBF measurements across multiple sites and to ensure that the recruitment target of 10 subjects will be met in time to allow for the subsequent NIH grant submission in 2017.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ischemic Conditioning | Experimental | Device: Doctormate, Other: Usual CareDoctormate device is used daily. |
| Usual Care | Other | Other: Usual CareStandard medical care. |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Symptomatic cerebral infarction within 30 days of enrollment attributed to 70-99% stenosis of a major intracranial artery (carotid artery, MCA stem (M1), vertebral artery, or basilar artery) that is documented by any of the following: MRA, CTA, or catheter angiography. Percent stenosis will be measured according to WASID criteria (= 1 - [Ds / Dn]) x 100% with Ds [diameter of stenosis] and Dn [diameter of normal vessel]).19
- Modified Rankin score of ≤ 3
- Age ≥ 30 years and ≤ 90 years. Subjects 30-49 years are required to meet at least one additional criteria (i-vi) provided in the table below to qualify for the study. This additional requirement is to increase the likelihood that the symptomatic intracranial stenosis in subjects 30-49 years is atherosclerotic.
- Recent (within 30 days) negative pregnancy test in a female who has had any menses in the last 12 months
- Subject is willing and able to return in 30 days for close-out visit for the study
Key exclusion criteria (22 listed)
- Previous treatment of target lesion with a stent, angioplasty, or other mechanical device, or plan to perform one of these procedures
- Plan to perform concomitant angioplasty or stenting of an extracranial vessel tandem to an intracranial stenosis
- Intracranial tumor (except meningioma) or any intracranial vascular malformation
- Thrombolytic therapy within 24 hours prior to enrollment
- Progressive neurological signs within 24 hours prior to enrollment
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 |
|---|---|---|
| DoctormateIschemic conditioning device | Device | Ischemic Conditioning |
| Usual CareStandard medical care | Other | Ischemic Conditioning, Usual Care |
Primary outcome
Percent Change in Cerebral Blood Flow (CBF)
Time frame: Baseline and 30 days
Percent change CBF from baseline to 30 days as determined by ASL MRI imaging.
Change in Putative Blood Biomarkers
Time frame: 30 days
Change in the absolute levels of the following biomarkers will be measured from baseline to 30 days: Nitrite, IL-10, SDF1, Micro RNA 144. Lp-PLA2, IL-6. hsCRP, Soluble E selectin, ICAm, MMP-9, PAI-1,tPA, ADMA
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Intracranial Atherosclerosis
Recruiting
Pemafibrate for Symptomatic ICAS RCT
Intracranial Atherosclerotic Disease (ICAD), Hypertriglyceridaemia
Not yet recruiting
EDAS Revascularization for Symptomatic Intracranial Atherosclerotic Steno-occlusive Disease
Intracranial Atherosclerosis, Intracranial Arterial Stenosis
RecruitingObservational study
BASIS Technique for Endovascular Therapy of Acute Large Vessel Occlusion Strokes Due to Intracranial Atherosclerotic Disease
Acute Ischemic Stroke, ICAS - Intracranial Atherosclerosis
Not yet recruiting
INtensive liPid-lowering Therapy for Acute High-risk IntracRanial or Extracranial atheroSclerosis -II (INSPIRES-2)
Ischemic Stroke or High-risk TIA (ABCD² ≥ 4)
Not yet recruitingPhase 4
RESCUE: PCSK9 Inhibitors for Carotid Vulnerable Plaque Remodeling
Atherosclerosis Cerebral, Carotid Plaque
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.
Marc I Chimowitz, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doctormate in people with Intracranial Atherosclerosis, run by Medical University of South Carolina at 1 site in United States.
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 15 inclusion and 22 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 7 Oct 2019. 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 United States. 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?
Yes. Results are posted in the registry (first posted 7 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Change in Cerebral Blood Flow (CBF) (time frame: Baseline and 30 days). The study lists 2 primary outcomes in all. 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 7 Oct 2019.