To assess the safety and feasibility of inducing mild hypothermia prior to reperfusion as a means of reducinginfarct size in subjects suffering from STEMI and improve neurologic outcome in subjects experiencing CA followingthe return of spontaneous…
ID
Source
Brief title
Condition
- Coronary artery disorders
- Encephalopathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety (composite of new-onset serious adverse event(s), feasibility, side
effects, and efficacy (infarct size).
Secondary outcome
* CA subgroup (with or without STEMI): Percentage of subjects with good
neurologic outcome (Glasgow
Outcome Score of 4 or 5] at any time during their hospital stay) and at 6 months
* STEMI subgroup (with or without CA): Myocardial infarct size at 14 days (± 3
days) post-procedure as measured by Tc99m Sestamibi single photon emission
computed tomography (SPECT).
* All cause mortality through 6 months post-procedure.
* Device success defined as the capability of the device to decrease subject
core temperature to 34°C within 30 minutes of treatment.
* STEMI subgroup (without CA): MACE at 30 days (± 7 days) as defined by death
or non-fatal reinfarction or ischemia-driven TVR.
Background summary
Recent studies have found that treatment with hypothermia in patients who have
been successfully resuscitated after
cardiac arrest increases the rate of favorable neurologic outcome and decreases
mortality.
While the safety and efficacy of induced mild hypothermia in cardiac arrest
patients is clear, one issue highlighted by
many investigators that might provide further and more consistent clinical
benefit concerns the timing with which hypothermic therapy is initiated and
mild hypothermia is induced.
Because of the nature of ischemic injury, intervening with hypothermia earlier
may disrupt the destructive cascade of events underlying neurologic injury more
effectively. However, the cooling speeds of current cooling methods ranges
from 0.2 to 2.5 degrees Celsius per hour.
Therapeutic hypothermia has shown great promise in animal models. Based on
these models (rabbits, pigs, sheep and dogs) a 10% reduction in myocardial
infarct size can be expected for every 1°C decrease in body temperature.
Many of these studies found that major reductions in infarct size were achieved
only when hypothermia
was induced prior to reperfusion therapy. Preliminary clinical data (COOL-MI 1
& 2 and ICE-IT trials) support this observation.
Study objective
To assess the safety and feasibility of inducing mild hypothermia prior to
reperfusion as a means of reducing
infarct size in subjects suffering from STEMI and improve neurologic outcome in
subjects experiencing CA following
the return of spontaneous circulation (ROSC).
Study design
Induction of mild hypothermia using automated peritoneal lavage in different
categories of patients (first in cardiac arrest patients, then in awake
patients with myocardial infarction. A total of 150 patients will be included
in these 2 phases.
Intervention
Cooling and maintaining mild hypothermia using an automated peritoneal lavage
system.
Study burden and risks
Possible complications as a consequence from the cooling method, e.g.
peritonitis, perforation of an intraabdominal organ. This risk is regarded as
very low in previous researc regarding this technique
The benefit is a significant better neurological outcome (according to the
present literature) and probably also a myocardial protective effect.
1455 Adams Drive
MENLO PARK, CA 94025
US
1455 Adams Drive
MENLO PARK, CA 94025
US
Listed location countries
Age
Inclusion criteria
1. cardiac arrest (in-hosptial or out-of hospital) with return of spontaneous circulation
2. myocardial infarction (18-85 years): STEMI
Exclusion criteria
1. Subject is known to be pregnant;
2. Subject is obeying commands;
3. Subject has a known history of abdominal surgery, peritonitis, or
currently undergoing regular peritoneal dialysis;
4. Subject has a known history of severe chronic obstructive
pulmonary disorder (COPD) (i.e., requires supplemental home
oxygen);
5. Subject has a known anatomic abnormality that in the
physician*s opinion will create additional risk when treating the
patient (i.e., profound obesity, abdominal aortic aneurysm,
abdominal wall hernia, spinal deformity, etc.);
6. Subject has a known severe neurological dysfunction evident
prior to the presenting acute event;
7. Subject has known significant concomitant illness (other than
cardiac arrest) with a life expectancy of < 1 year;
8. Subject is experiencing active, uncontrolled bleeding;
9. Subject has a known history of receiving thrombolytic
medication in the previous 6 weeks (treatment with other
anticoagulant medications, such as those required for PCI or
STEMI treatment, is not an exclusion);
10. cardiac arrest caused by massive CVA or trauma
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL29369.029.10 |