COOL-AMI EU Case Series Clinical Study
Verified March 2015 by ZOLL Circulation, Inc., USA
Information provided by (Responsible Party):
ZOLL Circulation, Inc., USA
First received: September 24, 2013
Last updated: March 2, 2015
Last verified: March 2015
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.
Acute Myocardial Infarction
||Observational Model: Case-Only
Time Perspective: Prospective
||COOL-AMI EU Case Series Clinical Study: 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 Acute Myocardial Infarction
Primary Outcome Measures:
- Time from hospital arrival to Percutaneous Coronary Intervention (PCI). [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
- Time from hospital arrival to initiation of cooling. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
- Proportion of subjects achieving target temperature. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Proportion of those enrolled that complete the study protocol. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2015 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- 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.
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02070913
|Ruppiner Kliniken GmbH
|Neuruppin, Germany |
|Contact: Kirk Schmailzl, M.D |
|Principal Investigator: Kirk Schmailzl, M.D |
|Institute of Cardiology,
|Warsaw, Poland |
|Contact: Adam Witkowski, MD, PhD,FESC |
|Principal Investigator: Adam Witkowski, MD, PhD,FESC |
|Silesian Center for Heart Diseases, Zabrze
|Zabrze, Poland |
|Contact: Beata Sredniawa, MD PhD |
|Principal Investigator: Beata Sredniawa, MD,PhD |
|Medical University in Łódź, Bieganski Hospital
|Łódź, Poland |
|Contact: Jan Peruga, M.D, PhD |
|Principal Investigator: Jan Peruga, M.D, PhD |
|Essex Cardiothoracic Centre, Anglia Ruskin University
|Basildon, Essex, United Kingdom |
|Contact: John Davies |
|Contact: Thomas Keeble, BScMDMCRP |
|Sub-Investigator: Thomas Keeble, BSc, M.D, MCRP |
|Principal Investigator: John Davies |
|Cardiac Research Sister, King's College Hospital
|London, United Kingdom |
|Contact: Rafal Dworakowski, M.D |
|Principal Investigator: Rafal Dworakowski, M.D |
ZOLL Circulation, Inc., USA
No publications provided
||ZOLL Circulation, Inc., USA
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 24, 2013
||March 2, 2015
||Poland: Ethics Committee
Keywords provided by ZOLL Circulation, Inc., USA:
Acute Myocardial Infarction
Percutaneous Coronary Intervention
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 26, 2015