Cardiac ArrestUNICORNNCT02611934
Mild Therapeutic Hypothermia for Patients With Acute Coronary Syndrome and Cardiac Arrest Treated With PCI
A study testing Mild Therapeutic Hypothermia (MHT) in people with Cardiac Arrest and Acute Coronary Syndrome, run by Jacek Kubica at 1 site in Poland.
Trial summary
Mild Therapeutic Hypothermia for Patients with Acute Coronary Syndrome and Cardiac Arrest Treated with Percutaneous Coronary Intervention (UNICORN) study is designed to determine whether mild therapeutic hypothermia (MTH) applied in patients with acute coronary syndromes (ACS) and cardiac arrest treated with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest, Acute Coronary Syndrome
- What is being tested?
- Mild Therapeutic Hypothermia (MHT)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePoland
- Study dates
- 14 Nov 2017to 31 Dec 2020
- 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
- Age ≥ 18 years
- Survivor of OHCA
- Sustained return of spontaneous circulation (ROSC) for more than 20 minutes after resuscitation
- Unconsciousness with a score of ≤8 on the Glasgow Coma Scale after ROSC
- Shockable initial rhythm
- Diagnosis or suspicion of ACS
Who cannot join
- Unwitnessed OHCA
- Obvious or suspected pregnancy
- Known serious infection/sepsis before OHCA
- Known bleeding diathesis
- Confirmed or suspected internal bleeding
- Confirmed or suspected acute stroke
Show all 13Show fewer
- Confirmed or suspected cerebral injury
- Known serious neurological dysfunction (CPC≤4) before OHCA
- Known serious disease making 180 days of survival unlikely
- Hemodynamic instability with systolic blood pressure <65 mmHg despite treatment
- Time delay from ROSC to MTH induction > 240 min.
- Asystole or pulseless electrical activity (PEA) as the initial rhythm
- Initial body temperature <30°C
Trial locations and contacts
1 site in 1 country.
Poland1 site
Cardiology Department, Dr. A. Jurasz University Hospital
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-094
About this study
Official title: Mild Therapeutic Hypothermia for Patients With Acute Coronary Syndrome and Cardiac Arrest Treated With Percutaneous Coronary Intervention
Mild Therapeutic Hypothermia for Patients with Acute Coronary Syndrome and Cardiac Arrest Treated with Percutaneous Coronary Intervention (UNICORN) study is designed to determine whether mild therapeutic hypothermia (MTH) applied in patients with acute coronary syndromes (ACS) and cardiac arrest treated with percutaneous coronary intervention (PCI) is associated with better clinical outcomes as compared with therapy without MTH.
Read the detailed description
The UNICORN study is a multi-center, international, observational, phase IV clinical trial which is aimed to investigate whether MTH applied in patients with ACS and cardiac arrest treated with PCI is associated with better clinical outcomes as compared with therapy without MTH. This trial will provide important information regarding the impact of MTH in unconscious with a score of ≤8 on the Glasgow Coma Scale on admission to the hospital after out-of-hospital cardiac arrest (OHCA) with diagnosed or presumed ACS and shockable initial rhythm.
- Conditions
- Cardiac Arrest, Acute Coronary Syndrome
- Being tested
- Mild Therapeutic Hypothermia (MHT)
- Medical subject headings
- Heart Arrest, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mild Therapeutic Hypothermia (MHT)Procedure or surgery
The induction with ice packs and infusion of 0.9% sodium chloride (NaCl) at the temperature of 4˚C. MHT will be maintained with a MTH-dedicated catheter introduced into the inferior vena cava through the femoral vein during PCI. MTH will be maintained for at least 12 hours at target temperature of 33˚C. The rewarming phase will be conducted in an actively controlled manner (0.3˚C per hour). The patient's core temperature will be independently measured in the urinary bladder as well as in the lower one third of the oesophagus using a dedicated catheter and tube. All patients treated with MTH will be mechanically ventilated with a concomitant continuous intravenous infusion of propofol and fentanyl for sedation and analgesia.
| Study group | Role | What they receive |
|---|---|---|
| Mild Therapeutic Hypothermia | Experimental | OHCA survivors with diagnosed or suspected ACS Receives: Procedure: Mild Therapeutic Hypothermia (MHT) |
| no-Mild Therapeutic Hypothermia | No intervention | OHCA survivors with diagnosed or suspected ACS |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Measured: 180 days
Secondary outcomes (5)
Neurological outcome according to Cerebral Performance Category (CPC)
Measured: at discharge (up to 180 days)
Early stent thrombosis
Definite or confirmed stent thrombosis - symptoms suggestive of an acute coronary syndrome and angiographic or pathologic confirmation of stent thrombosis within 30 days post stent implantation
Measured: 30 days
Bleedings according to the Bleeding Academic Research Consortium (BARC) criteria
bleeding events evaluated based on the BARC definitions
Measured: 180 days
Infectious complications
Measured: 180 days
Rhythm and conductions disorders
Rhythm and conductions disorders assessed based on ECG telemetry, 12-lead ECG and ECG holter monitoring
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2015 (estimated)
- Study start14 Nov 2017
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Why it stopped: Due to insufficient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jacek Kubica
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jacek Kubica, Collegium Medicum w Bydgoszczy
- Investigators
- Jacek Kubica, MD, PhD, Principal investigator, Collegium Medicum, Nicolaus Copernicus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02611934
- Sponsor's protocol ID
- CMUMK202C
- Acronym
- UNICORN
- Status last verified
- Jan 2021
- First submitted
- 18 Nov 2015
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Uminska JM, Ratajczak J, Buszko K, Sobczak P, Sroka W, Marszall MP, Adamski P, Steblovnik K, Noc M, Kubica J. Impact of mild therapeutic hypothermia on bioavailability of ticagrelor in patients with acute myocardial infarction after out-of-hospital cardiac arrest. Cardiol J. 2020;27(6):780-788. doi: 10.5603/CJ.a2019.0024. Epub 2019 Feb 25.
PubMed 30799546Uminska JM, Buszko K, Ratajczak J, Lach P, Pstragowski K, Dabrowska A, Adamski P, Skonieczny G, Manitius J, Kubica J. Comparison of temperature measurements in esophagus and urinary bladder in comatose patients after cardiac arrest undergoing mild therapeutic hypothermia. Cardiol J. 2020;27(6):735-741. doi: 10.5603/CJ.a2018.0115. Epub 2018 Sep 24.
PubMed 30246234
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mild Therapeutic Hypothermia for Patients With Acute Coronary Syndrome and Cardiac Arrest Treated With Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT02611934
- Acronym / sponsor ID
- UNICORN / CMUMK202C
- Conditions
- Cardiac Arrest, Acute Coronary Syndrome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to insufficient enrollment
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Jacek KubicaUniversity, hospital or other
- Study start
- 14 Nov 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 23 Nov 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.
Mild Therapeutic Hypothermia for Patients with Acute Coronary Syndrome and Cardiac Arrest Treated with Percutaneous Coronary Intervention (UNICORN) study is designed to determine whether mild therapeutic hypothermia (MTH) applied in patients with acute coronary syndromes (ACS) and cardiac arrest treated with percutaneous coronary intervention (PCI) is associated with better clinical outcomes as compared with therapy without MTH.
Detailed description
The UNICORN study is a multi-center, international, observational, phase IV clinical trial which is aimed to investigate whether MTH applied in patients with ACS and cardiac arrest treated with PCI is associated with better clinical outcomes as compared with therapy without MTH. This trial will provide important information regarding the impact of MTH in unconscious with a score of ≤8 on the Glasgow Coma Scale on admission to the hospital after out-of-hospital cardiac arrest (OHCA) with diagnosed or presumed ACS and shockable initial rhythm.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mild Therapeutic Hypothermia | Experimental | Procedure: Mild Therapeutic Hypothermia (MHT)OHCA survivors with diagnosed or suspected ACS |
| no-Mild Therapeutic Hypothermia | No intervention | –OHCA survivors with diagnosed or suspected ACS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Survivor of OHCA
- Sustained return of spontaneous circulation (ROSC) for more than 20 minutes after resuscitation
- Unconsciousness with a score of ≤8 on the Glasgow Coma Scale after ROSC
- Shockable initial rhythm
Key exclusion criteria (13 listed)
- Unwitnessed OHCA
- Obvious or suspected pregnancy
- Known serious infection/sepsis before OHCA
- Known bleeding diathesis
- Confirmed or suspected internal bleeding
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 |
|---|---|---|
| Mild Therapeutic Hypothermia (MHT)The induction with ice packs and infusion of 0.9% sodium chloride (NaCl) at the temperature of 4˚C. MHT will be maintained with a MTH-dedicated catheter introduced into the inferior vena cava through the femoral vein during PCI. MTH will be maintained for at least 12 hours at target temperature of 33˚C. The rewarming phase will be conducted in an actively controlled manner (0.3˚C per hour). The patient's core temperature will be independently measured in the urinary bladder as well as in the lower one third of the oesophagus using a dedicated catheter and tube. All patients treated with MTH will be mechanically ventilated with a concomitant continuous intravenous infusion of propofol and fentanyl for sedation and analgesia. | Procedure or surgery | Mild Therapeutic Hypothermia |
Primary outcome
All cause mortality
Time frame: 180 days
5 secondary outcomes
Neurological outcome according to Cerebral Performance Category (CPC)
Time frame: at discharge (up to 180 days)
Early stent thrombosis
Time frame: 30 days
Bleedings according to the Bleeding Academic Research Consortium (BARC) criteria
Time frame: 180 days
Infectious complications
Time frame: 180 days
Rhythm and conductions disorders
Time frame: 180 days
Results and safety
The study was stopped early (reason given: Due to insufficient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Derived from this study: PubMed 30799546Uminska JM, Ratajczak J, Buszko K, Sobczak P, Sroka W, Marszall MP, Adamski P, Steblovnik K, Noc M, Kubica J. Impact of mild therapeutic hypothermia on bioavailability of ticagrelor in patients with acute myocardial infarction after out-of-hospital cardiac arrest. Cardiol J. 2020;27(6):780-788. doi: 10.5603/CJ.a2019.0024. Epub 2019 Feb 25.
- Derived from this study: PubMed 30246234Uminska JM, Buszko K, Ratajczak J, Lach P, Pstragowski K, Dabrowska A, Adamski P, Skonieczny G, Manitius J, Kubica J. Comparison of temperature measurements in esophagus and urinary bladder in comatose patients after cardiac arrest undergoing mild therapeutic hypothermia. Cardiol J. 2020;27(6):735-741. doi: 10.5603/CJ.a2018.0115. Epub 2018 Sep 24.
- Study resultsLink provided by the sponsor.
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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.
Jacek Kubica, MD, PhD principal investigator
Collegium Medicum, Nicolaus Copernicus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mild Therapeutic Hypothermia (MHT) in people with Cardiac Arrest and Acute Coronary Syndrome, run by Jacek Kubica at 1 site in Poland.
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 13 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: stopped early, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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 was stopped early (reason given: Due to insufficient enrollment). Results are not available in the source record.
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?
All cause mortality (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02611934, which also lists 2 linked publications.
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 2 Feb 2021.