Acute Myocardial InfarctionNCT02509832
COOL AMI EU Pilot Trial to Assess Cooling as an Adjunctive Therapy to Percutaneous Intervention in Patients With Acute Myocardial Infarction
A study testing Cooling + PCI and PCI only in people with Acute Myocardial Infarction, run by ZOLL Circulation, Inc., USA at 13 sites in 8 countries.
Trial summary
COOL AMI EU Pilot Trial: A Multicenter, Prospective, Randomized Controlled Trial to Assess Cooling as an adjunctive Therapy to Percutaneous Intervention in Patients with Acute Myocardial Infarction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Cooling + PCI and PCI only
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 13 sitesin 8 countries
- Study dates
- Jul 2015to Jun 2018
- Phase
- Interventional
- 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
Who may be able to join
None listed.
Who cannot join
- All Exclusion Criteria must be answered NO for subject to be eligible for trial inclusion.
- Previous myocardial infarction.
- Cardiogenic shock (systolic blood pressure [SBP] <80 mmHg and non-responsive to fluids, or SBP <100 mmHg with vasopressors, or requirement for an intra-aortic balloon pump [IABP]).
- Resuscitated cardiac arrest, atrial fibrillation, or Killip risk stratification class II through IV
- Aortic dissection or requires an immediate surgical or procedural intervention other than PCI
- Congestive Heart Failure (CHF), hepatic failure, end- stage kidney disease or severe renal failure (clearance < 30ml/min/1.73m2).
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- Fever (temperature > 37.5 °C) or infection with fever in the last 5 days.
- Previous CABG.
- Stroke within 90 days of admission.
- Cardio-pulmonary decompensation present or imminent
- Contraindications to hypothermia, such as patients with known hematologic dyscrasias which affect thrombosis (e.g., cryoglobulinemia, sickle cell disease, serum cold agglutinins) or vasospastic disorders (such as Raynaud's or thromboangitis obliterans)
- Hypersensitivity or contraindication to aspirin, heparin, or sensitivity to contrast media, which cannot be adequately pre-medicated.
- History of bleeding diathesis, coagulopathy, cryoglobulinemia, sickle cell anemia, or will refuse blood transfusions.
- Height of <1.5 meters (4 feet 11 inches).
- Hypersensitivity to buspirone hydrochloride or Pethidine (Meperidine) and/or treatment with a monoamine oxidase inhibitor in the past 14 days.
- History of severe hepatic or renal impairment, untreated hypothyroidism, Addison's disease, benign prostatic hypertrophy, or urethral stricture that in the opinion of the physician would be incompatible with Pethidine administration.
- Inferior Vena Cava filter in place (IVC).
- The patient has a pre-MI life expectancy of <1 year due to underlying medical conditions or pre-existing co-morbidities.
- Known, unresolved history of drug use or alcohol dependency, or lacks the ability to comprehend or follow instructions.
- Currently enrolled in another investigational drug or device trial that has not completed the primary endpoint.
- Apprehension or unwilling to undergo the required MRI imaging at follow-up, has a documented or suspected diagnosis of claustrophobia, or has Gadolinium allergy
- Received thrombolytic therapy en route to the hospital
- Clinical evidence of spontaneous reperfusion as observed symptomatically and/ or from ECG findings (partial or complete ST resolution in ECG before randomization) upon admission
- Vulnerable subject, for instance, a person in detention (i.e., prisoner or ward of the state)
- Female who is known to be pregnant.
Trial locations and contacts
13 sites in 8 countries.
13 sites in 8 countries
Hungary3 sites
Heart Center Balatonfüred
Balatonfüred, 8230
Medical and Health Science Center University of Debrecen
Debrecen, 4032
Heart Institute University of Pecs
Pécs, H-7624
Poland3 sites
Medical University in Łódź, Bieganski Hospital
Lodz
National Institute of Cardiology, Department of Interventional Cardiology & Angiology
Warsaw, 04628
Silesian Center for Heart Diseases
Zabrze, 41-800
Serbia2 sites
Clinical Center of Serbia Head of Department for invasive diagnostics (Division of Cardiology)
Belgrade
University Clinical Hospital Center Zemun
Zemun
Austria1 site
Universitätsklinik für Notfallmedizin Allgemeines Krankenhaus der Stadt Wien
Vienna
United Kingdom1 site
Essex Cardiothoracic Centre, Anglia Ruskin University
Basildon, Essex
About this study
Official title: COOL-AMI EU PILOT TRIAL: A Multicenter, Prospective, Randomized Controlled Trial To Assess Cooling as an Adjunctive Therapy to Percutaneous Intervention in Patients With ACUTE MYOCARDIAL INFARCTION
COOL AMI EU Pilot Trial: A Multicenter, Prospective, Randomized Controlled Trial to Assess Cooling as an adjunctive Therapy to Percutaneous Intervention in Patients with Acute Myocardial Infarction.
Evaluate the retention of subjects after integrating therapeutic hypothermia using the ZOLL Proteus IVTM System into existing STEMI treatment protocols for subjects who present with acute anterior myocardial infarction.
Read the detailed description
Evaluate the retention of subjects after integrating therapeutic hypothermia using the ZOLL Proteus IVTM System into existing STEMI treatment protocols for subjects who present with acute anterior myocardial infarction.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Cooling + PCI, PCI only
- Keywords
- Therapeutic Hypothermia (TH), Acute Myocardial Infarction (AMI), Percutaneous Coronary Intervention (PCI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cooling + PCIDevice
Cooling with ZOLL Proteus IVTM System before and after Percutaneous Coronary Intervention (PCI)
PCI onlyDevice
Standard of Care for PCI
| Study group | Role | What they receive |
|---|---|---|
| Cooling + PCI | Other | The subjects will be considered to be enrolled in the Test Arm of the trial when all inclusion and exclusion criteria have been met, the informed consent form has been signed, and randomization to the Test Arm of the trial to allow cooling with the Proteus IVTM System before and after PCI. Receives: Device: Cooling + PCI |
| PCI only | Other | The subjects will be considered to be enrolled in the Control Arm of the trial when all inclusion and exclusion criteria have been met, the informed consent form has been signed, and randomization to the Control Arm of the trial to allow PCI only. Receives: Device: PCI only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of all subjects who complete the follow-up and cMR imaging requirements at 30-day follow up period
Measured: 30 day
Secondary outcomes (1)
1. Anterior Infarct Size (IS) as assessed by Cardiac Magnetic Resonance (cMR) at 4 - 6 days following the index procedure for subjects in Test and Control Arms
Measured: 4 - 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionMar 2018
- Study completionJun 2018
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZOLL Circulation, Inc., USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Holzer, Principal investigator, Universitätsklinik für Notfallmedizin Allgemeines Krankenhaus der Stadt WienMarko Noc, Principal investigator, University Medical Center Ljubljana Slovenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02509832
- Sponsor's protocol ID
- EDC-2420
- Status last verified
- Nov 2020
- First submitted
- 24 Jul 2015
- Last updated
- 25 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COOL-AMI EU PILOT TRIAL: A Multicenter, Prospective, Randomized Controlled Trial To Assess Cooling as an Adjunctive Therapy to Percutaneous Intervention in Patients With ACUTE MYOCARDIAL INFARCTION
- ClinicalTrials.gov ID
- NCT02509832
- Acronym / sponsor ID
- EDC-2420
- Conditions
- Acute Myocardial Infarction
- Keywords
- Therapeutic Hypothermia (TH), Acute Myocardial Infarction (AMI), Percutaneous Coronary Intervention (PCI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- ZOLL Circulation, Inc., USAIndustry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Mar 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 28 Jul 2015 (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.
COOL AMI EU Pilot Trial: A Multicenter, Prospective, Randomized Controlled Trial to Assess Cooling as an adjunctive Therapy to Percutaneous Intervention in Patients with Acute Myocardial Infarction.
Evaluate the retention of subjects after integrating therapeutic hypothermia using the ZOLL Proteus IVTM System into existing STEMI treatment protocols for subjects who present with acute anterior myocardial infarction.
Detailed description
Evaluate the retention of subjects after integrating therapeutic hypothermia using the ZOLL Proteus IVTM System into existing STEMI treatment protocols for subjects who present with acute anterior myocardial infarction.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cooling + PCI | Other | Device: Cooling + PCIThe subjects will be considered to be enrolled in the Test Arm of the trial when all inclusion and exclusion criteria have been met, the informed consent form has been signed, and randomization to the Test Arm of the trial to allow cooling with the Proteus IVTM System before and after PCI. |
| PCI only | Other | Device: PCI onlyThe subjects will be considered to be enrolled in the Control Arm of the trial when all inclusion and exclusion criteria have been met, the informed consent form has been signed, and randomization to the Control Arm of the trial to allow PCI only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (25 listed)
- All Exclusion Criteria must be answered NO for subject to be eligible for trial inclusion.
- Previous myocardial infarction.
- Cardiogenic shock (systolic blood pressure [SBP] <80 mmHg and non-responsive to fluids, or SBP <100 mmHg with vasopressors, or requirement for an intra-aortic balloon pump [IABP]).
- Resuscitated cardiac arrest, atrial fibrillation, or Killip risk stratification class II through IV
- Aortic dissection or requires an immediate surgical or procedural intervention other than PCI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cooling + PCICooling with ZOLL Proteus IVTM System before and after Percutaneous Coronary Intervention (PCI) | Device | Cooling + PCI |
| PCI onlyStandard of Care for PCI | Device | PCI only |
Primary outcome
Proportion of all subjects who complete the follow-up and cMR imaging requirements at 30-day follow up period
Time frame: 30 day
1 secondary outcome
1. Anterior Infarct Size (IS) as assessed by Cardiac Magnetic Resonance (cMR) at 4 - 6 days following the index procedure for subjects in Test and Control Arms
Time frame: 4 - 6 days
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 25 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.
Michael Holzer principal investigator
Universitätsklinik für Notfallmedizin Allgemeines Krankenhaus der Stadt Wien
Marko Noc principal investigator
University Medical Center Ljubljana Slovenia
13 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cooling + PCI and PCI only in people with Acute Myocardial Infarction, run by ZOLL Circulation, Inc., USA at 13 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 0 inclusion and 25 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 25 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 13 sites in Hungary, Poland, Serbia, Austria, Estonia 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?
Proportion of all subjects who complete the follow-up and cMR imaging requirements at 30-day follow up period (time frame: 30 day). 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 25 Nov 2020.