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Acute Anterior Myocardial InfarctionNCT00417638

Rapid Intravascular Cooling in Myocardial Infarction as Adjunctive to Percutaneous Coronary Intervention

A study of Acute Anterior Myocardial Infarction, run by ZOLL Circulation, Inc., USA at 1 site in Sweden.

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

Rapid MI-ICE-Pilot is designed to demonstrate the safety and efficacy of the Celsius Control™ System (CCS) endovascular catheter to reduce the infarct size resulting from acute anterior myocardial infarction when used in combination with cold saline as an adjunct to immediate percutaneous coronary intervention (PCI)… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Acute Anterior Myocardial Infarction
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteSweden
Study dates
Jan 2007to Oct 2009
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

  • Each eligible patient must meet the following inclusion criteria :
  • Have ECG evidence of ongoing acute anterior myocardial infarction, involving a large area of myocardium, as defined by the following ECG criteria: a. Anterior infarct: ST-segment elevation >0.2mV measured 0.08 sec after the J point in 2 or more anatomically contiguous precordial leads, V1 through V4; and/or >0.2mV in lead V5 V6
  • Present to the RAPID MI-ICE site within six (6) hours of the onset of acute cardiac ischemic signs or symptoms (such as chest pain or pressure, arm or jaw pain, dyspnea, nausea/vomiting, or syncope)
  • Be a candidate for PCI and have PCI planned as the immediate intervention.
  • Be willing and able to comply with study procedures, including returning for the MRI scan at 4 ±2 days and return for the clinical examination on Day 30
  • Provide written informed consent prior to the initiation of study-specific procedures
  • Be in Killips Class I

Who cannot join

  • Patients are not eligible for the study if they meet one or more of the following criteria:
  • Age less than eighteen (<18) years of age
  • Age greater than seventy-five (>75) years of age
  • Are pregnant
  • Have a suspected aortic dissection
  • History of a prior anterior myocardial infarct or prior large myocardial infarct.
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  • The suspected etiology of myocardial infarction is primarily related to substance abuse (e.g., cocaine, methamphetamine, etc.)
  • Acute administration of a thrombolytic agent for the qualifying MI
  • If (during the screening process) the determination is made by site-study personnel that initiation of cooling prior to diagnostic coronary angiography is technically not feasible for any reason (should the patient be randomized to the Hypothermia Arm), the prospective subject should not be enrolled
  • Require an immediate surgical or procedural intervention other than PCI (e.g. CABG)
  • Present in cardiogenic shock or with end-stage cardiomyopathy
  • Have undergone at least ten (10) minutes of cardiopulmonary resuscitation (CPR) prior to presentation to the PCI facility
  • History of previous MI with known, pre-existing, anterior pathologic Q-waves
  • History of surgical coronary artery revascularization (e.g., CABG, MIDCAB, or OPCAB)
  • Recent stroke (within 3 months)
  • Active bleeding, coagulopathy, or other contraindication to the placement of a heparin-coated 14F central venous catheter via a 14F femoral venous introducer sheath (e.g., known history of heparin induced thrombocytopenia, or IVC filter)
  • 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)
  • Personal or familial history of malignant hyperthermia
  • Known end-stage renal disease (ESRD; e.g., on dialysis, or status-post renal transplant), known hepatic failure (e.g., cirrhosis, or acute hepatitis), or any other contraindication to receiving meperidine (such as use of MAO inhibitors within previous 14 days, history of seizures, history of hypersensitivity to meperidine, etc.) [Note: Patients with a contraindication to buspirone administration may be enrolled but should not be given buspirone as part of the anti-shivering regimen.]
  • Any other acute or chronic condition which the Investigator believes will unacceptably increase the risk of study participation or interfere with study procedures and assessments
  • Deemed unsuitable by the investigators to participate in the study.
  • Signs of cardiogenic shock or other signs of significant heart failure such as rales over the lungs
  • Active or recent (within 1 month prior to study enrollment) participation in another investigational clinical research study

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Department of Cardiology, Lund University Hospital

    Lund

Other trials in Sweden

About this study

Official title: A Randomized, Controlled Study of the Use of Central Venous Catheter Core Cooling Combined With Cold Saline, and Rewarming as an Adjunct to Percutaneous Coronary Intervention For the Treatment of Acute Myocardial Infarction

Rapid MI-ICE-Pilot is designed to demonstrate the safety and efficacy of the Celsius Control™ System (CCS) endovascular catheter to reduce the infarct size resulting from acute anterior myocardial infarction when used in combination with cold saline as an adjunct to immediate percutaneous coronary intervention (PCI) in patients with an occluded infarct-related artery.

Read the detailed description

The CCS is an endovascular thermal control system that circulates cooled saline through an indwelling central venous catheter in a closed-loop manner. The system has received 510(k) approval from the FDA for use in temperature management in neuro-surgical and cardiac patients during surgery and in recovery/intensive care. It has also received European CE mark and Australian TGA approval. Animal data in a model of acute myocardial infraction support the hypothesis that rapid cooling, prior to acute PCI, may reduce infarct size. Meta-analysis of the previous acute MI trials ICE-IT (N = 228; 1:1 randomization, hypothermia : control, Innercool Therapies, Inc.) and COOL MI-I (Radiant Medical, Inc) suggests there is a reduction in infarct size as measured by 30-day SPECT in the population of patients with anterior MIs who were cooled below 35 C prior to PCI.

This study is designed to investigate the safety, feasibility and efficacy of rapid endovascular cooling in the setting of acute PCI in patients with anterior infarctions.

Being tested
Endovascular cooling by the Celsius Control System, Standard of care
Keywords
myocardial infarction, acute intervention, percutaneous intervention, endovascular cooling, endovascular rewarming
Medical subject headings
Anterior Wall Myocardial Infarction, Myocardial Infarction

What participants receive

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

  • Endovascular cooling by the Celsius Control SystemDevice

  • Standard of careOther

Study groups in NCT00417638
Study groupRoleWhat they receive
patients with acute STEMI - treatment with Hypothermia +PCIExperimentalHypothermia using endovascular cooling with the Celsius Control System as an adjunct therapy. Hypothermia before reperfusion by a combination of infusion of cold saline and endovascular catheter cooling as an adjunct therapy in patients with a STEMI scheduled to undergo primary percutaneous coronary intervention (PCI).
Receives: Device: Endovascular cooling by the Celsius Control System
Patients with an acute STEMI eligible for primary PCIActive comparatorStandard of care treatment or the control group Patients with an acute STEMI eligible for primary PCI
Receives: Other: Standard of care

What is being measured

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

  1. Cardiac MRI infarct size

    reduction in infarct size as a percentage of left ventricle size in the per protocol population.

    Measured: Day 4

Secondary outcomes (6)

  1. MRI infarct size

    Infarct size as percent of area at risk determined with T2-weighted MRI in per protocol population

    Measured: Day 4

  2. Myocardial necrosis

    CK-MB release through 24 hours as area under the curve

    Measured: 24 Hours

  3. NYHA/AHA Cardiac Functional Class

    used to describe stages of Heart Failure ( Class I, II, III and IV)

    Measured: Day 30

  4. Major Adverse Cardiac Events (MACE)

    MACE: Death, MI, re-hospitalization

    Measured: Month 12

  5. Angiographic outcomes

    TIMI flow grade, TIMI myocardial perfusion grade

    Measured: Day 1

  6. ST-segment resolution

    ST-segment resolution as a function of time

    Measured: Day 1

Timeline

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

  1. First posted4 Jan 2007 (estimated)
  2. Study startJan 2007
  3. Primary completionOct 2009
  4. Study completionOct 2009

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00417638
Sponsor's protocol ID
Rapid MI-ICE-Pilot
Status last verified
Jan 2010
First submitted
2 Jan 2007
Last updated
20 Aug 2020
Results posted
No
Data monitoring committee
No

Publications

  • Erlinge D, Gotberg M, Noc M, Lang I, Holzer M, Clemmensen P, Jensen U, Metzler B, James S, Botker HE, Omerovic E, Koul S, Engblom H, Carlsson M, Arheden H, Ostlund O, Wallentin L, Klos B, Harnek J, Olivecrona GK. Therapeutic hypothermia for the treatment of acute myocardial infarction-combined analysis of the RAPID MI-ICE and the CHILL-MI trials. Ther Hypothermia Temp Manag. 2015 Jun;5(2):77-84. doi: 10.1089/ther.2015.0009. Epub 2015 May 18.

    PubMed 25985169

  • Erlinge D, Gotberg M, Grines C, Dixon S, Baran K, Kandzari D, Olivecrona GK. A pooled analysis of the effect of endovascular cooling on infarct size in patients with ST-elevation myocardial infarction. EuroIntervention. 2013 Apr 22;8(12):1435-40. doi: 10.4244/EIJV8I12A217.

    PubMed 23164721

  • Gotberg M, Olivecrona GK, Koul S, Carlsson M, Engblom H, Ugander M, van der Pals J, Algotsson L, Arheden H, Erlinge D. A pilot study of rapid cooling by cold saline and endovascular cooling before reperfusion in patients with ST-elevation myocardial infarction. Circ Cardiovasc Interv. 2010 Oct;3(5):400-7. doi: 10.1161/CIRCINTERVENTIONS.110.957902. Epub 2010 Aug 24.

    PubMed 20736446

Questions about this trial

What is this clinical trial studying?

A study of Acute Anterior Myocardial Infarction, run by ZOLL Circulation, Inc., USA at 1 site in Sweden.

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 7 inclusion and 23 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 20 Aug 2020. 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 Sweden. 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 MRI infarct size (time frame: Day 4). 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 NCT00417638, which also lists 3 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 20 Aug 2020.

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