Acute; Myocardial Infarction, ComplicationsSHOCK-COOLNCT01890317
Mild Hypothermia in Cardiogenic Shock Complicating Myocardial Infarction
A study testing Mild hypothermia in people with Acute; Myocardial Infarction, Complications and Cardiogenic Shock, run by University of Leipzig at 1 site in Germany.
Trial summary
Prospective, randomized, single-center, controlled, open-label Pilot-study to investigate whether induction of mild hypothermia in addition to primary percutaneous coronary intervention and optimal medical therapy in myocardial infarction complicated by cardiogenic shock improves cardiac power index after 24 h. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute; Myocardial Infarction, Complications, Cardiogenic Shock
- What is being tested?
- Mild hypothermia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2012to Mar 2016
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute myocardial infarction complicated by cardiongenic shock
- Patients on mechanical ventilation at time of randomization
Who cannot join
- Out of hospital resuscitation with indication for mild hypothermia
- mechanical complications after acute myocardial infarction
- duration of cardiogenic shock > 12 hours
- age > 90 years
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Internal Medicine/Cardiology, University of Leipzig - Heart Center
Leipzig, Saxony, 04289
About this study
Official title: Randomized Pilot Study of Mild Hypothermia in Cardiogenic Shock Complicating Myocardial Infarction
Prospective, randomized, single-center, controlled, open-label Pilot-study to investigate whether induction of mild hypothermia in addition to primary percutaneous coronary intervention and optimal medical therapy in myocardial infarction complicated by cardiogenic shock improves cardiac power index after 24 h.
- Being tested
- Mild hypothermia
- Keywords
- Cardiogenic shock, acute myocardial infarction, mild hypothermia
- Medical subject headings
- Myocardial Infarction, Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mild hypothermiaProcedure or surgery
Induction of mild hypothermia with invasive cooling for 24 hr in addition to primary percutaneous coronary intervention and optimal medical therapy.
| Study group | Role | What they receive |
|---|---|---|
| Mild hypothermia | Experimental | Induction of mild hypothermia for 24 hr with invasive cooling in addition to primary percutaneous coronary intervention and optimal medical therapy Receives: Procedure: Mild hypothermia |
| Control | No intervention | Percutaneous coronary intervention and optimal medical therapy according to current guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Power Index after 24 hr.
Cardiac Power Index after 24 hours as surrogate endpoint.
Measured: 24 hours
Secondary outcomes (10)
30-days mortality
Measured: 30 days
Change of hemodynamics over the first 48 hr.
Measured: During first 48 hr
Catecholamine dose and duration of catecholamine support
Measured: 30 days
Length of ICU-stay
Measured: 30 days
Length of mechanical ventilation
Measured: 30 days
SAPS-II-Score
Simplified Acute Physiology Score for the first 4 days
Measured: 96 hours
Severe and moderate bleeding complications (GUSTO-definition)
Measured: 30 days
Sepsis
Measured: 30 days
Pneumonia
Measured: 30 days
Stroke
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2013 (estimated)
- Study startAug 2012
- Primary completionNov 2015
- Study completionMar 2016
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 Acute; Myocardial Infarction, ComplicationsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Holger Thiele, Heart Center Leipzig - University Hospital
- Investigators
- Holger Thiele, MD, Study chair, Heart Center Leipzig - University HospitalGeorg Fuernau, MD, Principal investigator, Heart Center Leipzig - University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01890317
- Sponsor's protocol ID
- HZLCOOL1
- Acronym
- SHOCK-COOL
- Status last verified
- Jul 2018
- First submitted
- 24 Jun 2013
- Last updated
- 6 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Cheng W, Fuernau G, Desch S, Freund A, Feistritzer HJ, Poss J, Buettner P, Thiele H. Circulating Monocyte Chemoattractant Protein-1 in Patients with Cardiogenic Shock Complicating Acute Myocardial Infarction Treated with Mild Hypothermia: A Biomarker Substudy of SHOCK-COOL Trial. J Cardiovasc Dev Dis. 2022 Aug 20;9(8):280. doi: 10.3390/jcdd9080280.
PubMed 36005444Fuernau G, Beck J, Desch S, Eitel I, Jung C, Erbs S, Mangner N, Lurz P, Fengler K, Jobs A, Vonthein R, de Waha-Thiele S, Sandri M, Schuler G, Thiele H. Mild Hypothermia in Cardiogenic Shock Complicating Myocardial Infarction. Circulation. 2019 Jan 22;139(4):448-457. doi: 10.1161/CIRCULATIONAHA.117.032722.
PubMed 30026282
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Pilot Study of Mild Hypothermia in Cardiogenic Shock Complicating Myocardial Infarction
- ClinicalTrials.gov ID
- NCT01890317
- Acronym / sponsor ID
- SHOCK-COOL / HZLCOOL1
- Keywords
- Cardiogenic shock, acute myocardial infarction, mild hypothermia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Nov 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 1 Jul 2013 (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.
Prospective, randomized, single-center, controlled, open-label Pilot-study to investigate whether induction of mild hypothermia in addition to primary percutaneous coronary intervention and optimal medical therapy in myocardial infarction complicated by cardiogenic shock improves cardiac power index after 24 h.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mild hypothermia | Experimental | Procedure: Mild hypothermiaInduction of mild hypothermia for 24 hr with invasive cooling in addition to primary percutaneous coronary intervention and optimal medical therapy |
| Control | No intervention | –Percutaneous coronary intervention and optimal medical therapy according to current guidelines |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Acute myocardial infarction complicated by cardiongenic shock
- Patients on mechanical ventilation at time of randomization
Key exclusion criteria (4 listed)
- Out of hospital resuscitation with indication for mild hypothermia
- mechanical complications after acute myocardial infarction
- duration of cardiogenic shock > 12 hours
- age > 90 years
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 hypothermiaInduction of mild hypothermia with invasive cooling for 24 hr in addition to primary percutaneous coronary intervention and optimal medical therapy. | Procedure or surgery | Mild hypothermia |
Primary outcome
Cardiac Power Index after 24 hr.
Time frame: 24 hours
Cardiac Power Index after 24 hours as surrogate endpoint.
10 secondary outcomes
30-days mortality
Time frame: 30 days
Change of hemodynamics over the first 48 hr.
Time frame: During first 48 hr
Catecholamine dose and duration of catecholamine support
Time frame: 30 days
Length of ICU-stay
Time frame: 30 days
Length of mechanical ventilation
Time frame: 30 days
SAPS-II-Score
Time frame: 96 hours
Severe and moderate bleeding complications (GUSTO-definition)
Time frame: 30 days
Sepsis
Time frame: 30 days
Pneumonia
Time frame: 30 days
Stroke
Time frame: 30 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 6 Jul 2018.
- Derived from this study: PubMed 36005444Cheng W, Fuernau G, Desch S, Freund A, Feistritzer HJ, Poss J, Buettner P, Thiele H. Circulating Monocyte Chemoattractant Protein-1 in Patients with Cardiogenic Shock Complicating Acute Myocardial Infarction Treated with Mild Hypothermia: A Biomarker Substudy of SHOCK-COOL Trial. J Cardiovasc Dev Dis. 2022 Aug 20;9(8):280. doi: 10.3390/jcdd9080280.
- Derived from this study: PubMed 30026282Fuernau G, Beck J, Desch S, Eitel I, Jung C, Erbs S, Mangner N, Lurz P, Fengler K, Jobs A, Vonthein R, de Waha-Thiele S, Sandri M, Schuler G, Thiele H. Mild Hypothermia in Cardiogenic Shock Complicating Myocardial Infarction. Circulation. 2019 Jan 22;139(4):448-457. doi: 10.1161/CIRCULATIONAHA.117.032722.
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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.
Holger Thiele, MD study chair
Heart Center Leipzig - University Hospital
Georg Fuernau, MD principal investigator
Heart Center Leipzig - University Hospital
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 hypothermia in people with Acute; Myocardial Infarction, Complications and Cardiogenic Shock, run by University of Leipzig at 1 site in Germany.
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 2 inclusion and 4 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 6 Jul 2018. 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 Germany. 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?
Cardiac Power Index after 24 hr. (time frame: 24 hours). 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 NCT01890317, 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 6 Jul 2018.