- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02411877
REperfusion With Cooling in CerebraL Acute IscheMia II (RECCLAIM-II)
Study Overview
Status
Conditions
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.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
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Georgia
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Marietta, Georgia, United States, 30060
- WellStar Kennestone Regional Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female subjects of any ethnicity and age >/=18 but </= 79 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 CT imaging of the brain;
- 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, conscious sedation, or allergies to any components associated with the anticipated diagnostic or treatment procedures that cannot be treated;
- A pre-treatment modified Rankin Scale (mRS) of 0 or 1;
- Baseline 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 or legally authorized representative must be able to understand and give written informed consent.
Exclusion Criteria:
- 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) >1.7 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;
- 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;
- Prior neurologic event that would obscure interpretation of the signal and current presenting neurologic deficits;
- 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;
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Normothermia
As part of standard of care, an interventional reperfusion procedure will be performed on all subjects using the Trevo Pro Retriever (Stryker), after which normothermia will attempt to keep core body temp between 38 and 36.5 degrees centigrade.
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Device: Trevo Pro Retriever (Stryker Corp.)
Other Names:
Device: Trevo Pro Retriever (Stryker Corp.)
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Experimental: Mild hypothermia
As part of standard of care, an interventional reperfusion procedure will be performed on all subjects using the Trevo Pro Retriever (Stryker).
Subjects will also have a catheter placed in the femoral vein (Zoll Thermogard XP technology with the Quattro catheter) 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.
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Device: Trevo Pro Retriever (Stryker Corp.)
Device: Zoll Thermogard XP technology with the Quattro catheter Device: Trevo Pro Retriever (Stryker Corp.)
Other Names:
Device: Zoll Thermogard XP technology with the Quattro catheter
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hemorrhagic Conversion
Time Frame: 48 hours
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Acute bleeding into the area of the original stroke based on CT or MRI of the head.
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48 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with adverse events
Time Frame: 90 days
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Evaluation and determination of the following complications pneumonias, central line infections, intra-cerebral hemorrhages, systemic hemorrhages, transient cerebral ischemia, and new strokes.
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90 days
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Hyperintense Acute Reperfusion Marker (HARM)
Time Frame: 48 +/- 24 hours
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HARM is a MRI sequence looking at gadolinium enhancement on FLAIR MRI imaging.
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48 +/- 24 hours
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National Institutes of Health Stroke Scale (NIHSS)
Time Frame: Baseline, 24 +/- 6 hours, 48 +/- 24 hours, 8 +/- 2 days, 90 +/- 15 days
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NIHSS is a scale from 1-42 to evaluate stroke severity
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Baseline, 24 +/- 6 hours, 48 +/- 24 hours, 8 +/- 2 days, 90 +/- 15 days
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Modified Rankin Scale (mRS)
Time Frame: Basline, 48 +/- 24 hours, 90 +/- 15 days
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mRS is a straightforward evaluation of the functional limitations from stroke
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Basline, 48 +/- 24 hours, 90 +/- 15 days
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Rishi Gupta, MD, WellStar Health System
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Cardiovascular disease
- Stroke
- Ischemia
- Hypothermia
- Acute ischemic stroke
- Signs and symptoms
- Vascular disease
- Brain disease
- Brain infarction
- Brain ischemia
- Cerebral infarction
- Mild hypothermia
- Cerebrovascular disorder
- Central nervous system disease
- Nervous system disease
- Pathologic process
- Body temperature change
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Stroke
- Body Temperature Changes
- Ischemic Stroke
- Ischemia
- Hypothermia
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents, Local
- Anti-Infective Agents
- Enzyme Inhibitors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Antifungal Agents
- Steroid Synthesis Inhibitors
- 14-alpha Demethylase Inhibitors
- Cytochrome P-450 CYP2C9 Inhibitors
- Clotrimazole
- Miconazole
Other Study ID Numbers
- RECCLAIM II-S
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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