Acute Myocardial InfarctionNCT02070913
COOL-AMI EU Case Series Clinical Study
An observational study of Acute Myocardial Infarction, run by ZOLL Circulation, Inc., USA at 23 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- How many people
- 352 participants
- Where
- 23 sitesin 8 countries
- Study dates
- Sep 2013to 16 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
23 sites in 8 countries.
23 sites in 8 countries
Hungary8 sites
Heart Center Balatonfüred
Balatonfüred, 8230
Gottsegen Hungarian Institute of Cardiology
Budapest, 1096
Semmelweis University Heart and Vascular Center
Budapest, 1122
Medical Centre Hungarian Defence Forces
Budapest, 1134
Medical and Health Science Center University of Debrecen
Debrecen, 4032
University of Miskolc Borsod-Abauj-Zemplen County Hospital and University Teaching Hospital
Miskolc, 3526
Heart Institute University of Pecs
Pécs, 7623
Szent-Györgyi Albert Clinical Centre, II (University of Szeged)
Szeged, 6725
Poland4 sites
Nicolaus Copernicus University, Collegium Medicum University Hospital
Bydgoszcz, 85-094
Medical University in Łódź, Bieganski Hospital
Lodz
Institute of Cardiology,
Warsaw
Silesian Center for Heart Diseases, Zabrze
Zabrze
United Kingdom4 sites
Royal Sussex County Hospital
Brighton, BN2 5BE
The London Barts Department of Cardiology
London, E2 9JX
Cardiac Research Sister, King's College Hospital
London
Manchester Heart Centre Manchester Royal InfirmaryCentral Manchester University Hospitals NHS Foundation Trust
Manchester, M13 9WL
Serbia3 sites
Clinical Center of Serbia Head of Department for invasive diagnostics (Division of Cardiology)
Belgrade
Institute of Cardiovascular Diseases Vojvodina
Kamenitz, 21204
University Clinical Hospital Center Zemun
Zemun
Czechia1 site
University Hospital Brno, Internal and Cardiology Department
Brno, 625 00
Lithuania1 site
Vilnius University Hospital (Santariskiu Klinikos, Santariskiu)
Vilnius, 08661
About this 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
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.
- Conditions
- Acute Myocardial Infarction
- Keywords
- Hypothermia, Acute Myocardial Infarction, Percutaneous Coronary Intervention, AMI, PCI, Therapeutic Hypothermia
- Medical subject headings
- Hypothermia
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from hospital arrival to Percutaneous Coronary Intervention (PCI).
Measured: 24 hours
Time from hospital arrival to initiation of cooling.
Measured: 24 hours
Proportion of subjects achieving target temperature.
Measured: 24 hours
Secondary outcomes (1)
Proportion of those enrolled that complete the study protocol.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2014 (estimated)
- Study startSep 2013
- Primary completion16 Apr 2019
- Study completion16 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZOLL Circulation, Inc., USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02070913
- Sponsor's protocol ID
- EDC-2191
- Status last verified
- Jun 2020
- First submitted
- 24 Sep 2013
- Last updated
- 27 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02070913
- Acronym / sponsor ID
- EDC-2191
- Conditions
- Acute Myocardial Infarction
- Keywords
- Hypothermia, Acute Myocardial Infarction, Percutaneous Coronary Intervention, AMI, PCI, Therapeutic Hypothermia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- ZOLL Circulation, Inc., USAIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- 16 Apr 2019 (actual)
- Study completion
- 16 Apr 2019 (actual)
- First posted
- 25 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time from hospital arrival to Percutaneous Coronary Intervention (PCI).
Time frame: 24 hours
Time from hospital arrival to initiation of cooling.
Time frame: 24 hours
Proportion of subjects achieving target temperature.
Time frame: 24 hours
1 secondary outcome
Proportion of those enrolled that complete the study protocol.
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
23 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction, run by ZOLL Circulation, Inc., USA at 23 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Hungary, Poland, United Kingdom, Serbia, Czechia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from hospital arrival to Percutaneous Coronary Intervention (PCI). (time frame: 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2020.