Stroke, AcutePhase 1ReCCLAIMNCT01585597
Reperfusion With Cooling in Cerebral Acute Ischemia
A Phase 1 study testing Zoll- Coolgaurd 3000 in people with Stroke, Acute, run by Emory University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether reducing a patients body temperature (mild hypothermia of 33 degrees Centigrade) will significantly reduce the risk of brain injury (notably reperfusion injury and hemorrhagic conversion) in patients that have suffered a significant interruption of blood flow to an… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- Zoll- Coolgaurd 3000
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Aug 2012
- Phase
- Phase 1
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-85 years old
- Symptoms consistent with an ischemic stroke with a large vessel occlusion (MCA, ICA-terminus) as determined by vascular imaging
- ASPECTS score of 5-7 on non-contrast CT of the brain
- Ability to undergo endovascular reperfusion therapy
- Must have no contraindications to general anesthesia
- A pre-treatment modified Rankin Score of 0 or 1
- Arterial puncture performed under 8 hours from symptom onset or last seen normal
- Immediate post reperfusion CT scan shows no hemorrhage
Who cannot join
- Bleeding diathesis with a platelet count < 50,000 or INR > 1.5
- Involved in another clinical trial
- History of dementia
- End stage renal disease on hemodialysis
- History of ventricular dysrhythmias
- Life threatening medical condition precluding survival under 6 months
- Presence of an IVC filter
- Contrast dye allergy with history of anaphylaxis
Trial locations and contacts
1 site in 1 country.
United States1 site
Marcus Stroke and Neuroscience Center at Grady Memorial Hospital
Atlanta, Georgia, 30303
About this study
Official title: Phase 1 Study of Mild Induced Hypothermia After Endovascular Revascularization in Acute Ischemic Stroke of the Anterior Circulation
The purpose of this study is to determine whether reducing a patients body temperature (mild hypothermia of 33 degrees Centigrade) will significantly reduce the risk of brain injury (notably reperfusion injury and hemorrhagic conversion) in patients that have suffered a significant interruption of blood flow to an area of brain (occlusion of large proximal cerebral artery) and have undergone successful removal of that interruption (revascularization).
- Conditions
- Stroke, Acute
- Being tested
- Zoll- Coolgaurd 3000
- Keywords
- Ischemic Stoke, Endovascular Reperfusion, Reperfusion Injury, Mild hypothermia
- Medical subject headings
- Stroke, Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoll- Coolgaurd 3000Device
Goal temperature of 33 degrees Centigrade for a duration of 12 hours and then actively rewarmed by 0.2 degrees Centigrade per hour.
| Study group | Role | What they receive |
|---|---|---|
| Mild Hypothermia | Experimental | Reduction of body temperature to 34 degrees centigrade. This will be accomplished using the Zoll Coolguard . Receives: Device: Zoll- Coolgaurd 3000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Reperfusion Injury \ Hemorrhagic Transformation
Asymptomatic and symptomatic Hemorrhages defined as homogenous density occupying >30% of the infarct zone with mass effect
Measured: 24 Hours
Secondary outcomes (1)
Modified Rankin Scale 0-2
Modified Rankin Score 0=no symptoms
- no significant disability
- slight disability needs help
- moderate disability
- moderate serve disability
- severe disability 0-2 = good outcome 3-5= poor outcome
Measured: 90 days post hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2012 (estimated)
- Study startMay 2012
- Primary completionAug 2012
- Study completionAug 2012
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher M. Horn, MD, Emory University
- Investigators
- Rishi Gupta, MD, Study director, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01585597
- Sponsor's protocol ID
- IRB00056889
- Other IDs
- MSNC 01
- Acronym
- ReCCLAIM
- Status last verified
- Jul 2014
- First submitted
- 22 Apr 2012
- Last updated
- 1 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Horn CM, Sun CH, Nogueira RG, Patel VN, Krishnan A, Glenn BA, Belagaje SR, Thomas TT, Anderson AM, Frankel MR, Schindler KM, Gupta R. Endovascular Reperfusion and Cooling in Cerebral Acute Ischemia (ReCCLAIM I). J Neurointerv Surg. 2014 Mar;6(2):91-5. doi: 10.1136/neurintsurg-2013-010656. Epub 2013 Mar 6.
PubMed 23468538
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Mild Induced Hypothermia After Endovascular Revascularization in Acute Ischemic Stroke of the Anterior Circulation
- ClinicalTrials.gov ID
- NCT01585597
- Acronym / sponsor ID
- ReCCLAIM / IRB00056889
- Conditions
- Stroke, Acute
- Keywords
- Ischemic Stoke, Endovascular Reperfusion, Reperfusion Injury, Mild hypothermia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 26 Apr 2012 (estimated)
- Results
- Posted 1 Aug 2014
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 whether reducing a patients body temperature (mild hypothermia of 33 degrees Centigrade) will significantly reduce the risk of brain injury (notably reperfusion injury and hemorrhagic conversion) in patients that have suffered a significant interruption of blood flow to an area of brain (occlusion of large proximal cerebral artery) and have undergone successful removal of that interruption (revascularization).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mild Hypothermia | Experimental | Device: Zoll- Coolgaurd 3000Reduction of body temperature to 34 degrees centigrade. This will be accomplished using the Zoll Coolguard . |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18-85 years old
- Symptoms consistent with an ischemic stroke with a large vessel occlusion (MCA, ICA-terminus) as determined by vascular imaging
- ASPECTS score of 5-7 on non-contrast CT of the brain
- Ability to undergo endovascular reperfusion therapy
- Must have no contraindications to general anesthesia
Key exclusion criteria (8 listed)
- Bleeding diathesis with a platelet count < 50,000 or INR > 1.5
- Involved in another clinical trial
- History of dementia
- End stage renal disease on hemodialysis
- History of ventricular dysrhythmias
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 |
|---|---|---|
| Zoll- Coolgaurd 3000Goal temperature of 33 degrees Centigrade for a duration of 12 hours and then actively rewarmed by 0.2 degrees Centigrade per hour. | Device | Mild Hypothermia |
Primary outcome
Number of Participants With Reperfusion Injury \ Hemorrhagic Transformation
Time frame: 24 Hours
Asymptomatic and symptomatic Hemorrhages defined as homogenous density occupying >30% of the infarct zone with mass effect
1 secondary outcome
Modified Rankin Scale 0-2
Time frame: 90 days post hospitalization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23468538Horn CM, Sun CH, Nogueira RG, Patel VN, Krishnan A, Glenn BA, Belagaje SR, Thomas TT, Anderson AM, Frankel MR, Schindler KM, Gupta R. Endovascular Reperfusion and Cooling in Cerebral Acute Ischemia (ReCCLAIM I). J Neurointerv Surg. 2014 Mar;6(2):91-5. doi: 10.1136/neurintsurg-2013-010656. Epub 2013 Mar 6.
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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.
Rishi Gupta, MD study director
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Zoll- Coolgaurd 3000 in people with Stroke, Acute, run by Emory University 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 8 inclusion and 8 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 1 Aug 2014. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Aug 2014). 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?
Number of Participants With Reperfusion Injury \ Hemorrhagic Transformation (time frame: 24 Hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01585597, which also lists 1 linked publication.
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 1 Aug 2014.