Clinical trial NCT02070913: COOL-AMI EU Case Series Clinical Study
Official title: A Single-Center Case Series Clinical Study to Assess the Feasibility of Integrating Therapeutic Hypothermia Using the ZOLL IVTM System as an Adjunctive Therapy to Percutaneous Coronary Intervention in Patients With AMI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myocardial Infarction
Keywords: Hypothermia
Acute Myocardial Infarction
Percutaneous Coronary Intervention
AMI
PCI
Therapeutic Hypothermia
Lead sponsor: ZOLL Circulation, Inc., USA
Sponsor class: INDUSTRY
First posted: 2014-02-25
Enrollment: 352
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who present with clinical signs and symptoms of acute myocardial infarction and meet all Inclusion and Exclusion criteria will be considered for case study presentation in this clinical trial without regard to age, gender or ethnicity.

Brief summary: A single-center, prospective case series clinical study consecutively enrolling up to 10 patients with expected duration of 12 months or less. The study objectives are to evaluate retention and the feasibility of integrating therapeutic hypothermia using the ZOLL IVTM System.


Eligibility criteria: Inclusion Criteria:

* The patient is 18 years of age.
* The patient must have symptoms consistent with AMI
* MI with ST-segment elevation
* The patient is eligible for PCI.
* The expected timing of the treatment pathway for the patient will allow for at least 10 minutes of cooling with the IVTM System prior to PCI.
* The patient or patient legal representative is willing to provide written, informed consent to participate in this clinical study.

Exclusion Criteria:

* The patient has had a previous myocardial infarction
* The patient is experiencing cardiogenic shock
* The patient is experiencing acute pulmonary edema.
* The patient is presenting with cardiac arrest.
* The patient is presenting with Killip risk stratification class II through IV.
* The patient is presenting with Atrial Fibrillation.
* The patient has a history of a prior large myocardial infarct or an infarct in the same segment that is currently affected.
* The patient requires an immediate surgical or procedural intervention other than PCI
* The patient has an aortic dissection.
* The patient has hepatic failure.
* The patient has end stage kidney disease.
* The patient is febrile
* Known chronic Congestive Heart Failure (CHF).
* Known previous CABG.
* Known recent stroke
* Cardio-pulmonary decompensation that has occurred en route to the hospital
* Contraindications to hypothermia
* The patient has a known hypersensitivity or contraindication to aspirin, heparin, or sensitivity to contrast media, which cannot be adequately pre-medicated.
* The patient has a known history of coagulopathy
* The patient is known to be pregnant
* The patient has a known hypersensitivity to antishivering medications.
* Patient has a known history of severe hepatic or renal impairment.
* The patient has an Inferior Vena Cava filter in place (IVC).
* The patient has a life expectancy of less than 1 year
* The patient has a known, unresolved history of drug use
* The patient is currently enrolled another investigational drug or device trial

Primary outcomes:
measure: Time from hospital arrival to Percutaneous Coronary Intervention (PCI).
timeFrame: 24 hours
measure: Time from hospital arrival to initiation of cooling.
timeFrame: 24 hours
measure: Proportion of subjects achieving target temperature.
timeFrame: 24 hours
Secondary outcomes:
measure: Proportion of those enrolled that complete the study protocol.
timeFrame: 24 hours
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: University Hospital Brno, Internal and Cardiology Department
city: Tallinn
country: Estonia
facility: North Estonia Medical Center
city: Neuruppin
country: Germany
facility: Ruppiner Kliniken GmbH
city: Balatonfüred
country: Hungary
facility: Heart Center Balatonfüred
city: Budapest
country: Hungary
facility: Gottsegen Hungarian Institute of Cardiology
city: Budapest
country: Hungary
facility: Semmelweis University Heart and Vascular Center
city: Budapest
country: Hungary
facility: Medical Centre Hungarian Defence Forces
city: Debrecen
country: Hungary
facility: Medical and Health Science Center University of Debrecen
city: Miskolc
country: Hungary
facility: University of Miskolc Borsod-Abauj-Zemplen County Hospital and University Teaching Hospital
city: Pecs
country: Hungary
facility: Heart Institute University of Pecs
city: Szeged
country: Hungary
facility: Szent-Györgyi Albert Clinical Centre, II (University of Szeged)
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital (Santariskiu Klinikos, Santariskiu)
city: Bydgoszcz
country: Poland
facility: Nicolaus Copernicus University, Collegium Medicum University Hospital
city: Warsaw
country: Poland
facility: Institute of Cardiology,
city: Zabrze
country: Poland
facility: Silesian Center for Heart Diseases, Zabrze
city: Łódź
country: Poland
facility: Medical University in Łódź, Bieganski Hospital
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia Head of Department for invasive diagnostics (Division of Cardiology)
city: Sremska Kamenica
country: Serbia
facility: Institute of Cardiovascular Diseases Vojvodina
city: Zemun
country: Serbia
facility: University Clinical Hospital Center Zemun
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital
city: London
country: United Kingdom
facility: The London Barts Department of Cardiology
city: London
country: United Kingdom
facility: Cardiac Research Sister, King's College Hospital
city: Manchester
country: United Kingdom
facility: Manchester Heart Centre Manchester Royal InfirmaryCentral Manchester University Hospitals NHS Foundation Trust
Study officials:
References: