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ST-elevation Myocardial InfarctionNCT01864343

Target Temperature Management In Myocardial Infarction - A Pilot Study

A study testing EMCOOLS flex pad; Philips Innercool RTx in people with ST-elevation Myocardial Infarction, run by Medical University of Vienna at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary goal in the treatment of acute myocardial infarction is to reperfuse the ischemic myocardium to reduce infarct size. Animal data and human data suggest that whole-body cooling to temperatures below 35°C before revascularisation can additionally reduce infarct size and therefore improves outcome in these… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
ST-elevation Myocardial Infarction
What is being tested?
EMCOOLS flex pad; Philips Innercool RTx
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteAustria
Study dates
Sep 2011to May 2013
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age between 18 and 75 years
  • Immediately transfer to cath-lab is possible
  • Anterior or inferior ST-Elevation myocardial infarction
  • ST-Segment elevation of >0.2mV in 2 or more anatomically contiguous leads
  • Duration of symptoms <6 hours

Who cannot join

  • Participation in another study
  • Patients presenting with cardiac arrest
  • Tympanic temperature of <35.0°C prior enrolment
  • Thrombolysis therapy
  • Previous myocardial infarction in medical history
  • Previous percutaneous coronary intervention or coronary artery bypass graft
Show all 14Show fewer
  • Severe heart failure (defined as a New York Heart Association (NYHA) score of III or IV), Killip class II through IV at presentation
  • Clinical signs of infection
  • End-stage kidney disease or hepatic failure
  • Recent stroke (within the last six month)
  • Conditions that may be exacerbated by hypothermia, such as haematological dyscrasias, oral anticoagulant treatment with international normalized radio >1.5, severe pulmonary disease
  • Pregnancy. Women of childbearing potential are excluded
  • Allergy to meperidine, buspirone, magnesium, or polyvinyl chloride
  • Use of a monoamine oxidase inhibitor such as selegiline in the previous 14 days

Trial locations and contacts

1 site in 1 country.

Austria1 site

  • Medical University of Vienna

    Vienna, State of Vienna, 1090

Other trials in Austria

About this study

The primary goal in the treatment of acute myocardial infarction is to reperfuse the ischemic myocardium to reduce infarct size. Animal data and human data suggest that whole-body cooling to temperatures below 35°C before revascularisation can additionally reduce infarct size and therefore improves outcome in these patients.

The purpose of the study is to determine the feasibility and safety of a combined cooling strategy started in the out-of-hospital arena for achieving pre-reperfusion hypothermia in patients with acute st-elevation myocardial infarction.

Being tested
EMCOOLS flex pad; Philips Innercool RTx
Keywords
Myocardial Infarction, Myocardial Reperfusion Injury, Reperfusion Injury, Anterior Wall Myocardial Infarction, Inferior Wall Myocardial Infarction, Myocardial Ischemia
Medical subject headings
ST Elevation Myocardial Infarction, Myocardial Infarction, Myocardial Reperfusion Injury, Reperfusion Injury, Anterior Wall Myocardial Infarction, Inferior Wall Myocardial Infarction, Myocardial Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EMCOOLS flex pad; Philips Innercool RTxDevice

    Surface cooling with EMCOOLS flex pads (out-of-hospital); Infusion of 1000ml to 2000ml of cold saline (out-of-hospital); central-venous cooling (Philips Innercool RTx)

Study groups in NCT01864343
Study groupRoleWhat they receive
Pre- and perinterventional hypothermiaExperimentalCooling will be initiated by the application of cooling pads in the out-of-hospital setting followed by an infusion of 1000-2000ml of cold saline. In the cath lab a endovascular cooling catheter will be placed into the inferior vena cava via a femoral vein to achieve a core temperature of <35°C prior to revascularization.
Receives: Device: EMCOOLS flex pad; Philips Innercool RTx

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of a combined cooling strategy for achieving a core temperature of <35.0°C at the time of reperfusion of the infarct related artery

    Blood temperature will be recorded at the time of first wire-crossed lesion of the infarct related coronary stenosis

    Measured: Time of reperfusion of the culprit lesion in st-elevation myocardial infarction (expected average 120 minutes)

Secondary outcomes (3)

  1. Safety of a combined cooling strategy as an adjunctive therapy on primary percutaneous coronary intervention in acute st-elevation myocardial infarction

    Incidence of major adverse cardiac events as defined as: death, heart failure, pulmonary edema, recurrent MI, malignant arrhythmias (i.e. ventricular fibrillation, sustained ventricular tachycardia) emergent stent revascularisation, any hospitalisation, major/minor bleeding (according to TIMI-bleeding score), infection (clinical relevant infection with the need of systemic antimicrobiotic therapy) within a period of 45±15 days

    Measured: within 45 days (+/- 15 days)

  2. Tolerability of a combined cooling strategy as an adjunctive therapy on primary percutaneous coronary intervention in acute st-elevation myocardial infarction

    Patients are monitored for incidence of shivering using a 4-point scale: 0, no shivering evident; 1, isolated facial or masticatory fasciculation; 2, peripheral shivering; 3, uncontrolled rigor during the cooling procedure (in average the first 4 hours)

    Measured: during active cooling and rewarming (in average the first 4 hours)

  3. Time to revascularisation (first medical contact to balloon time)

    The time to reperfusion of the infarct related artery is crucial in acute ST-elevation myocardial infarction. To evaluate if the cooling procedure has a substantial influence on this time frame we measure the time from first medical contact to reperfusion.

    Measured: Time of reperfusion (in average 120 minutes)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2013 (estimated)
  2. Study startSep 2011
  3. Primary completionApr 2013
  4. Study completionMay 2013

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01864343
Sponsor's protocol ID
STATIM-Pilot
Other IDs
MUW_492/2011
Status last verified
May 2013
First submitted
17 May 2013
Last updated
29 May 2013
Results posted
No
Data monitoring committee
No

Publications

  • Testori C, Sterz F, Delle-Karth G, Malzer R, Holzer M, Stratil P, Stockl M, Weiser C, van Tulder R, Gangl C, Sebald D, Zajicek A, Buchinger A, Lang I. Strategic target temperature management in myocardial infarction--a feasibility trial. Heart. 2013 Nov;99(22):1663-7. doi: 10.1136/heartjnl-2013-304624. Epub 2013 Sep 24.

    PubMed 24064228

Questions about this trial

What is this clinical trial studying?

A study testing EMCOOLS flex pad; Philips Innercool RTx in people with ST-elevation Myocardial Infarction, run by Medical University of Vienna at 1 site in Austria.

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 5 inclusion and 14 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 29 May 2013. 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 Austria. 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?

Feasibility of a combined cooling strategy for achieving a core temperature of <35.0°C at the time of reperfusion of the infarct related artery (time frame: Time of reperfusion of the culprit lesion in st-elevation myocardial infarction (expected average 120 minutes)). 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 NCT01864343, which also lists 1 linked publication.

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 29 May 2013.

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