Ischemic StrokeReCCLAIM IINCT01728649

Reperfusion With Cooling in Cerebral Acute Ischemia II

A study testing Mild Hypothermia in people with Ischemic Stroke and Hypothermia, run by WellStar Health System at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Ischemic Stroke, Hypothermia
What is being tested?: Mild Hypothermia
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteUnited States
Study dates: Feb 2013to Jun 2015
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 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female subjects of any ethnicity and age >/=18 but </= 85 years;
Symptom onset </=8 hours;
Symptoms consistent with an ischemic stroke with a large vessel occlusion (Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA) terminus) as determined by vascular imaging, CT or MRI;
Alberta Stroke Program Early CT Score (ASPECTS) of 5-10 on non-contrast CT of the brain;
Ability to undergo endovascular reperfusion therapy;
No contraindications to general anesthesia or allergies to any components associated with the anticipated diagnostic or treatment procedures that cannot be treated;

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A pre-treatment modified Rankin Scale (mRS) of 0 or 1;
Arterial puncture performed under 8 hours from symptom onset or last seen normal
Baseline MRI or CT scan shows no hemorrhage;
National Institutes of Health Stroke Scale (NIHSS) 14-29;
Subject has either 1) failed iv tissue plasminogen activator (tPA) therapy or 2) contradicted for iv tPA therapy;
Subject is capable of complying with study procedures and agrees to complete all required study procedures, study visits and associated activities.
Subject must be able to understand and give written informed consent.

Who cannot join

Females of childbearing potential who are pregnant or not using adequate contraception;
Bleeding diathesis with a platelet count < 50,000 or International Normalized Ratio (INR) >1.5 or any active or recent (within 10 to 30 days) hemorrhage;
History of genetically confirmed hypercoagulable syndrome;
Any condition that excludes MRI imaging;
History of dementia, currently on Aricept or Namenda, or other Alzheimer's like symptoms;
End stage renal disease on hemodialysis;

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History of cardiac arrest;
Presence of an inferior vena cava (IVC) filter;
Contrast dye allergy with history of anaphylaxis, known serious sensitivity to contrast agents or any condition in which angiography is contraindicated;
Known allergy to meperidine or buspar;
Sustained hypertension (systolic blood pressure (SBP) > 185 or diastolic blood pressure (DBP) > 110 refractory to treatment);
Baseline CT/MRI of head showing evidence of mass effect with mid-line shift, hemorrhage, intracranial tumor, arterial vasculitis or dissection, or bilateral stroke;
Presence of any other serious comorbidity that would be likely to impact life expectancy to less than 6 months or limit subject cooperation or study compliance;
Concurrent participation in an investigational clinical study that has not completed the follow-up period or planned participation in another study within the next 3 months;
Subject has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete, good quality data or the completion of the research study

Trial locations and contacts

1 site in 1 country.

United States1 site

Grady Memorial Hospital
Atlanta, Georgia, 30303

Other trials in United States

About this study

Official title: Phase 2 Study of Mild Hypothermia in Combination With Acute Cerebral Vascular Reperfusion in the Setting of Acute Ischemic Stroke

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).This will be achieved by comparing patients that have undergone hypothermia to those that have not.

Read the detailed description

This study is designed to examine the safety and proof of concept of therapeutic hypothermia prior to conventional revascularization in subjects experiencing acute ischemic stroke by comparing the results to subjects who remain at normal body temperature (normothermic) and proceed directly to reperfusion via conventional reperfusion intervention. The investigational plan also examines the following outcomes in 85 subjects randomized to either hypothermia or normothermia:

Regulation of biomarkers indicative of ischemia-reperfusion injury
Changes in blood brain injury using the Hyperintense Acute Reperfusion Marker (HARM) protocol MRI as a surrogate imaging biomarker
Incidence of hemorrhagic conversion post reperfusion
Neurologic function at 90 days post acute ischemic stroke. The results of this study will be used to power a definitive phase III clinical trial evaluating the combination of hypothermia and revascularization versus reperfusion alone.

Conditions: Ischemic Stroke, Hypothermia
Being tested: Mild Hypothermia
Keywords: Acute Ischemic Stroke, Mild Hypothermia, Stroke, Hypothermia
Medical subject headings: Ischemic Stroke, Hypothermia, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mild HypothermiaOther
Also called Hypothermia, Therapeutic Hypothermia
Hypothermia will be achieved using the Zoll Thermoguard XP technology with the Quattro catheter. This catheter has a 9.3 Fr diameter and is 4 3cm long. It will be placed in the patients femoral vein via Seldinger technique, before reperfusion is achieved. Hypothermia will be initiated prior to reperfusion. Once temperature has reached 33.5 degrees centigrade the patient will remain at that temperature for 12 hours after which the patient will undergo active gradual rewarming at 0.2 degrees centigrade per hour.

Study groups in NCT01728649
Study group	Role	What they receive
Normothermia	No intervention	As part of standard of care, an interventional reperfusion procedure will be performed on all subjects using current FDA approved devices. After which patient will be started on normothermia attempting to keep core body temp between 38 and 36.5 degrees centigrade. Patients will also undergo blood draws for biomarkers before reperfusion is achieved the immediately, 6 hours then 24 hours after reperfusion.
Mild Hypothermia	Experimental	As part of standard of care, an interventional reperfusion procedure will be performed on all subjects using current FDA cleared device. Patient will also have a Quattro catheter placed in the femoral vein and temperature brought to 33 degrees centigrade as quickly as possible. They will stay in mild hypothermia for 12 hours and then be rewarmed very slowly. Patients will also undergo blood draws for biomarkers before reperfusion is achieved the immediately, 6 hours then 24 hours after reperfusion. Receives: Other: Mild Hypothermia

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of participants with adverse events
Evaluation and determination of the following complications pneumonias, central line infections, intra-cerebral hemorrhages, systemic hemorrhages, transient cerebral ischemia, and new strokes.
Measured: 90 days

Secondary outcomes (5)

Hyperintense Acute Reperfusion Marker (HARM)
HARM is a MRI sequence looking at gadolinium enhancement on FLAIR MRI imaging.
Measured: 48+/- 24 hours
Hemorrhagic Conversion
Acute bleeding into the area of the original stroke based on CT or MRI of the head.
Measured: 48hrs
National Institutes of Health Stroke Scale (NIHSS)
NIHSS is a scale from 1-42 to evaluate stroke severity
Measured: 90 days
Modified Rankin Scale (mRS)
mRS is a straightforward evaluation of the functional limitations from stroke
Measured: 90 days
Biomarkers
These biomarkers are indicative of ischemia-reperfusion injury
Measured: Before therapy then immediately after, 8hrs, and 24hrs after reperfusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2013Jun 2015

First posted20 Nov 2012 (estimated)
Study startFeb 2013
Primary completionFeb 2015 (estimated)
Study completionJun 2015 (estimated)

Why it stopped: unable to be funded

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: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01728649
Sponsor's protocol ID: MSNC 02
Acronym: ReCCLAIM II
Status last verified: Sep 2018
First submitted: 5 Sep 2012
Last updated: 13 Sep 2018
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Ischemic Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 2 Study of Mild Hypothermia in Combination With Acute Cerebral Vascular Reperfusion in the Setting of Acute Ischemic Stroke
ClinicalTrials.gov ID: NCT01728649
Acronym / sponsor ID: ReCCLAIM II / MSNC 02
Conditions: Ischemic Stroke, Hypothermia
Keywords: Acute Ischemic Stroke, Mild Hypothermia, Stroke, Hypothermia
Study type: Interventional
Recruitment status: WithdrawnReason stopped: unable to be funded
Enrolment: 0 participants (actual)
Lead sponsor: WellStar Health SystemUniversity, hospital or other
Study start: Feb 2013
Primary completion: Feb 2015 (estimated)
Study completion: Jun 2015 (estimated)
First posted: 20 Nov 2012 (estimated)
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.

Detailed description

Regulation of biomarkers indicative of ischemia-reperfusion injury
Changes in blood brain injury using the Hyperintense Acute Reperfusion Marker (HARM) protocol MRI as a surrogate imaging biomarker
Incidence of hemorrhagic conversion post reperfusion
Neurologic function at 90 days post acute ischemic stroke. The results of this study will be used to power a definitive phase III clinical trial evaluating the combination of hypothermia and revascularization versus reperfusion alone.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Normothermia	No intervention	–As part of standard of care, an interventional reperfusion procedure will be performed on all subjects using current FDA approved devices. After which patient will be started on normothermia attempting to keep core body temp between 38 and 36.5 degrees centigrade. Patients will also undergo blood draws for biomarkers before reperfusion is achieved the immediately, 6 hours then 24 hours after reperfusion.
Mild Hypothermia	Experimental	Other: Mild HypothermiaAs part of standard of care, an interventional reperfusion procedure will be performed on all subjects using current FDA cleared device. Patient will also have a Quattro catheter placed in the femoral vein and temperature brought to 33 degrees centigrade as quickly as possible. They will stay in mild hypothermia for 12 hours and then be rewarmed very slowly. Patients will also undergo blood draws for biomarkers before reperfusion is achieved the immediately, 6 hours then 24 hours after reperfusion.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Male or female subjects of any ethnicity and age >/=18 but </= 85 years;
Symptom onset </=8 hours;
Symptoms consistent with an ischemic stroke with a large vessel occlusion (Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA) terminus) as determined by vascular imaging, CT or MRI;
Alberta Stroke Program Early CT Score (ASPECTS) of 5-10 on non-contrast CT of the brain;
Ability to undergo endovascular reperfusion therapy;

Key exclusion criteria (15 listed)

Females of childbearing potential who are pregnant or not using adequate contraception;
Bleeding diathesis with a platelet count < 50,000 or International Normalized Ratio (INR) >1.5 or any active or recent (within 10 to 30 days) hemorrhage;
History of genetically confirmed hypercoagulable syndrome;
Any condition that excludes MRI imaging;
History of dementia, currently on Aricept or Namenda, or other Alzheimer's like symptoms;

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
Mild HypothermiaAlso: Hypothermia, Therapeutic HypothermiaHypothermia will be achieved using the Zoll Thermoguard XP technology with the Quattro catheter. This catheter has a 9.3 Fr diameter and is 4 3cm long. It will be placed in the patients femoral vein via Seldinger technique, before reperfusion is achieved. Hypothermia will be initiated prior to reperfusion. Once temperature has reached 33.5 degrees centigrade the patient will remain at that temperature for 12 hours after which the patient will undergo active gradual rewarming at 0.2 degrees centigrade per hour.	Other	Mild Hypothermia

Primary outcome

Number of participants with adverse events
Time frame: 90 days
Evaluation and determination of the following complications pneumonias, central line infections, intra-cerebral hemorrhages, systemic hemorrhages, transient cerebral ischemia, and new strokes.

5 secondary outcomes

Hyperintense Acute Reperfusion Marker (HARM)
Time frame: 48+/- 24 hours
Hemorrhagic Conversion
Time frame: 48hrs
National Institutes of Health Stroke Scale (NIHSS)
Time frame: 90 days
Modified Rankin Scale (mRS)
Time frame: 90 days
Biomarkers
Time frame: Before therapy then immediately after, 8hrs, and 24hrs after reperfusion

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2018.

Related trials for Ischemic Stroke

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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
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RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
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Recruiting
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Stroke, Ischemic

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.

Christopher Horn, MD principal investigator

Emory University

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 study testing Mild Hypothermia in people with Ischemic Stroke and Hypothermia, run by WellStar Health System 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 13 inclusion and 15 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: withdrawn, as of the sponsor's last update on 13 Sep 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 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?

The study was withdrawn before enrolling participants, so there are no results.

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 adverse events (time frame: 90 days). 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 NCT01728649.

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 13 Sep 2018.