Efficacy of Endovascular Catheter Cooling Combined With Cold Saline for the Treatment of Acute Myocardial Infarction

NCT01379261 | Completed Phase 2 DMC

• 1 other identifier: CHILL-MI
• Study Type: interventional
• Target: 120
• Locations: 4 countries
• Sites: 10

Brief Summary

The purpose of this study is to determine whether treatment of patients suffering from ST-elevation myocardial infarction (STEMI) with 1-2 liters of cold saline and central venous catheter cooling with Philips InnerCool RTx Endovascular System prior to percutaneous coronary intervention (PCI) result in a reduction in infarct size.

Conditions

Myocardial Infarction; Myocardial Reperfusion Injury; Anterior Wall Myocardial Infarction; Inferior Wall Myocardial Infarction

Keywords

STEMI; primary PCI; Hypothermia; Endovascular cooling; Cardiac MRI

Outcome Measures

Primary Outcomes (1)

• Myocardial infarct size (as a percentage of myocardium at risk) assessed by cardiac MRI.

  At 4±2 days

Secondary Outcomes (18)

• Myocardial infarct size (as a percentage of myocardium at risk) both assessed by cardiac MRI at 4±2 days in the patients who are cooled and achieve a target temperature of < 35 C prior to PCI.

  At 4±2 days

• Myocardial infarct size (as a percentage of myocardium at risk) both assessed by cardiac MRI at 4±2 days in patients with an occluded and non-occluded IRA before PCI.

  At 4±2 days

• Myocardial infarct size (as a percentage of myocardium at risk) both assessed by cardiac MRI at 4±2 days in the per protocol population who are cooled according to protocol and meet inclusion criteria.

  At 4±2 days

• Myocardial infarct size (as a percentage of myocardium at risk) both assessed by cardiac MRI at 4±2 days in patients with anterior or inferior myocardial infarctions separately.

  At 4±2 days

• The effect of the hypothermia protocol on the incidence of death.

  45±15 days and 6 months.

Study Arms (2)

Hypothermia treatment

ACTIVE COMPARATOR

1-2 liters of cold saline and central venous catheter cooling with Philips InnerCool RTx Endovascular System prior to PCI

Procedure: Cooling

Standard treatment

NO INTERVENTION

Standard treatment

Interventions

Cooling PROCEDURE

1-2 liters of cold saline and central venous catheter cooling with Philips InnerCool RTx Endovascular System prior to PCI

Also known as: Hypothermia

Hypothermia treatment

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical symptoms and signs of myocardial infarction and have a 12-lead ECG providing evidence of an ongoing acute myocardial infarction, involving a large area of myocardium, as defined by the following ECG criteria. The ECG changes should be present upon arrival to the cath lab:
• 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.
• Inferior infarct: ST elevation \>0.2mV measured 0.08 sec after the J point in 2 or more anatomically contiguous inferior leads, coupled with ST depression in 2 contiguous anterior leads for a total ST deviation (inferior ST elevation plus anterior ST depression) of \>0.8mV.
• Present to the study PCI lab 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 be available for additional follow up Subject understands study procedures and agrees to participate in the study by giving written informed consent.
• Be in Killips Class I.

You may not qualify if:

• Age less than eighteen (\<18) years of age
• Age greater than or equal to eighty (80) years of age
• Are pregnant.
• Having an aortic dissection
• History of a prior large myocardial infarct or an infarct in the same segment that is currently affected.
• Acute administration of a thrombolytic agent for the qualifying MI
• Clinical suspicion of a non-thrombotic (e.g., pericarditis, vasospasm, takotsubo, illicit drug use) cause for ST-segment elevation as determined by the investigator
• 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.
• Known risk for heparin induced thrombocytopenia (HIT)
• 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 surgical coronary artery revascularization (e.g. CABG)
• 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

Sponsors & Collaborators

• Region Skane: lead
• Philips Healthcare: collaborator
• Lund University: collaborator
• Uppsala University: collaborator

Study Sites (10)

Graz University Hospital

Graz, A-8036, Austria

Location

Innsbruck University Hospital

Innsbruck, A-6020, Austria

Location

Medical University of Vienna

Vienna, A-1090, Austria

Location

Aarhus University Hospital

Aarhus, DK-8200, Denmark

Location

Rigshospitalet - Copenhagen University Hospital

Copenhagen, DK-2100, Denmark

Location

University Medical Centre

Ljubljana, Slovenia

Location

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Skane University Hospital, Lund, Sweden

Lund, 22185, Sweden

Location

Karolinska University Hospital

Stockholm, Sweden

Location

Uppsala University Hospital

Uppsala, 75185, Sweden

Location

Related Publications (6)

• Nordlund D, Heiberg E, Carlsson M, Frund ET, Hoffmann P, Koul S, Atar D, Aletras AH, Erlinge D, Engblom H, Arheden H. Extent of Myocardium at Risk for Left Anterior Descending Artery, Right Coronary Artery, and Left Circumflex Artery Occlusion Depicted by Contrast-Enhanced Steady State Free Precession and T2-Weighted Short Tau Inversion Recovery Magnetic Resonance Imaging. Circ Cardiovasc Imaging. 2016 Jul;9(7):e004376. doi: 10.1161/CIRCIMAGING.115.004376.

  PMID: 27412659 DERIVED

• Engblom H, Tufvesson J, Jablonowski R, Carlsson M, Aletras AH, Hoffmann P, Jacquier A, Kober F, Metzler B, Erlinge D, Atar D, Arheden H, Heiberg E. A new automatic algorithm for quantification of myocardial infarction imaged by late gadolinium enhancement cardiovascular magnetic resonance: experimental validation and comparison to expert delineations in multi-center, multi-vendor patient data. J Cardiovasc Magn Reson. 2016 May 4;18(1):27. doi: 10.1186/s12968-016-0242-5.

  PMID: 27145749 DERIVED

• Tufvesson J, Carlsson M, Aletras AH, Engblom H, Deux JF, Koul S, Sorensson P, Pernow J, Atar D, Erlinge D, Arheden H, Heiberg E. Automatic segmentation of myocardium at risk from contrast enhanced SSFP CMR: validation against expert readers and SPECT. BMC Med Imaging. 2016 Mar 5;16:19. doi: 10.1186/s12880-016-0124-1.

  PMID: 26946139 DERIVED

• 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.

  PMID: 25985169 DERIVED

• Erlinge D, Gotberg M, Lang I, Holzer M, Noc M, Clemmensen P, Jensen U, Metzler B, James S, Botker HE, Omerovic E, Engblom H, Carlsson M, Arheden H, Ostlund O, Wallentin L, Harnek J, Olivecrona GK. Rapid endovascular catheter core cooling combined with cold saline as an adjunct to percutaneous coronary intervention for the treatment of acute myocardial infarction. The CHILL-MI trial: a randomized controlled study of the use of central venous catheter core cooling combined with cold saline as an adjunct to percutaneous coronary intervention for the treatment of acute myocardial infarction. J Am Coll Cardiol. 2014 May 13;63(18):1857-65. doi: 10.1016/j.jacc.2013.12.027. Epub 2014 Feb 5.

  PMID: 24509284 DERIVED

• 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.

  PMID: 23164721 DERIVED

MeSH Terms

Conditions

Myocardial Infarction; Myocardial Reperfusion Injury; Anterior Wall Myocardial Infarction; Inferior Wall Myocardial Infarction; ST Elevation Myocardial Infarction; Hypothermia

Interventions

Cool-Down Exercise

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Cardiomyopathies; Reperfusion Injury; Postoperative Complications; Body Temperature Changes; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Post-Exercise Recovery Techniques; Physical Therapy Modalities; Therapeutics; Rehabilitation; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• David Erlinge, MD PhD

  Department of Cardiology, Skane University Hospital, Lund, Sweden

  PRINCIPAL INVESTIGATOR

• Göran K Olivecrona, MD PhD

  Department of Cardiology, Skane University Hospital, Lund, Sweden

  PRINCIPAL INVESTIGATOR

• Anthony Mullins

  Philips Healthcare, San Diego, CA, USA

  STUDY DIRECTOR

• Lars Wallentin, MD PhD

  Uppsala University Hospital, Uppsala, Sweden

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2011
• First Posted: June 23, 2011
• Study Start: June 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 6, 2014

Record last verified: 2014-11

Locations

AU (3); DK (2); SL (1); SE (4)