COOL-AMI EU Case Series Clinical Study

Sponsor

ZOLL Circulation, Inc., USA (Industry)

Overall Status

Completed

CT.gov ID

NCT02070913

Collaborator

(none)

352

Enrollment

Locations

67.4

Duration (Months)

15.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myocardial Infarction

Study Design

Study Type:

Observational

Actual Enrollment :

352 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

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 Start Date :

Sep 1, 2013

Actual Primary Completion Date :

Apr 16, 2019

Actual Study Completion Date :

Apr 16, 2019

Outcome Measures

Primary Outcome Measures

Time from hospital arrival to Percutaneous Coronary Intervention (PCI). [24 hours]
Time from hospital arrival to initiation of cooling. [24 hours]
Proportion of subjects achieving target temperature. [24 hours]

Secondary Outcome Measures

Proportion of those enrolled that complete the study protocol. [24 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	University Hospital Brno, Internal and Cardiology Department	Brno	Czechia	625 00
2	North Estonia Medical Center	Tallinn	Estonia	13419
3	Ruppiner Kliniken GmbH	Neuruppin	Germany
4	Heart Center Balatonfüred	Balatonfüred	Hungary	8230
5	Gottsegen Hungarian Institute of Cardiology	Budapest	Hungary	1096
6	Semmelweis University Heart and Vascular Center	Budapest	Hungary	1122
7	Medical Centre Hungarian Defence Forces	Budapest	Hungary	1134
8	Medical and Health Science Center University of Debrecen	Debrecen	Hungary	4032
9	University of Miskolc Borsod-Abauj-Zemplen County Hospital and University Teaching Hospital	Miskolc	Hungary	3526
10	Heart Institute University of Pecs	Pecs	Hungary	7623
11	Szent-Györgyi Albert Clinical Centre, II (University of Szeged)	Szeged	Hungary	6725
12	Vilnius University Hospital (Santariskiu Klinikos, Santariskiu)	Vilnius	Lithuania	08661
13	Nicolaus Copernicus University, Collegium Medicum University Hospital	Bydgoszcz	Poland	85-094
14	Institute of Cardiology,	Warsaw	Poland
15	Silesian Center for Heart Diseases, Zabrze	Zabrze	Poland
16	Medical University in Łódź, Bieganski Hospital	Łódź	Poland
17	Clinical Center of Serbia Head of Department for invasive diagnostics (Division of Cardiology)	Belgrade	Serbia
18	Institute of Cardiovascular Diseases Vojvodina	Sremska Kamenica	Serbia	21204
19	University Clinical Hospital Center Zemun	Zemun	Serbia
20	Royal Sussex County Hospital	Brighton	United Kingdom	BN2 5BE
21	The London Barts Department of Cardiology	London	United Kingdom	E2 9JX
22	Cardiac Research Sister, King's College Hospital	London	United Kingdom
23	Manchester Heart Centre Manchester Royal InfirmaryCentral Manchester University Hospitals NHS Foundation Trust	Manchester	United Kingdom	M13 9WL