Efficacy of Endovascular Catheter Cooling Combined With Cold Saline for the Treatment of Acute Myocardial Infarction (CHILL-MI)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Philips Healthcare
Lund University
Uppsala University
Information provided by (Responsible Party):
Region Skane
ClinicalTrials.gov Identifier:
NCT01379261
First received: June 21, 2011
Last updated: April 4, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Myocardial Infarction
Myocardial Reperfusion Injury
Anterior Wall Myocardial Infarction
Inferior Wall Myocardial Infarction
Procedure: Cooling
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Rapid Endovascular Catheter Core Cooling Combined With Cold Saline as an Adjunct to Percutaneous Coronary Intervention For the Treatment of Acute Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by Region Skane:

Primary Outcome Measures:
  • Myocardial infarct size (as a percentage of myocardium at risk) assessed by cardiac MRI. [ Time Frame: At 4±2 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: At 4±2 days ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: At 4±2 days ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: At 4±2 days ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: At 4±2 days ] [ Designated as safety issue: No ]
  • The effect of the hypothermia protocol on the incidence of death. [ Time Frame: 45±15 days and 6 months. ] [ Designated as safety issue: No ]
  • Plasma level of high sensitivity Troponin T AUC through 48 hours and peak plasma level of high sensitivity Troponin T within 48 hours after AMI. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • ST-segment resolution 1.5 hour after opening the IRA. [ Time Frame: 1.5 hours ] [ Designated as safety issue: No ]
  • Coronary blood flow and coronary angiography at the index event estimated by TIMI coronary flow and coronary perfusion grading. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
  • Plasma NT-proBNP levels at day 4±2. [ Time Frame: Day 4±2. ] [ Designated as safety issue: Yes ]
  • Incidence of death at 1, 2, 3, 4 and 5 years. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Myocardial infarct size (as a percentage of myocardium at risk) assessed by cardiac MRI at 6±1 months. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Incidence of heart failure within 45±15 days. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Incidence of pulmonary oedema. [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
  • Incidence of infections [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
  • Incidence of bleedings [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
  • The effect of the hypothermia protocol on the incidence of recurrent MI. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • The effect of the hypothermia protocol on the incidence of emergent stent revascularisation. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • The effect of the hypothermia protocol on the incidence of any hospitalisation. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: June 2011
Estimated Study Completion Date: August 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Hypothermia treatment
1-2 liters of cold saline and central venous catheter cooling with Philips InnerCool RTx Endovascular System prior to PCI
Procedure: Cooling
1-2 liters of cold saline and central venous catheter cooling with Philips InnerCool RTx Endovascular System prior to PCI
Other Name: Hypothermia
No Intervention: Standard treatment
Standard treatment

Detailed Description:

Acute myocardial infarction (AMI) is the leading cause of mortality in the western world today. Although reperfusion of the ischemic myocardium is a prerequisite for myocardial salvage, it has been described that the reperfusion in itself may cause additional damage to the myocardium (reperfusion injury). In the safety & feasibility trial RAPID MI-ICE we demonstrated that treatment of patients suffering from STEMI with 1-2 liters of cold saline and central venous catheter cooling with Philips InnerCool RTx Endovascular System prior to PCI was feasible, safe and resulted in a 38% reduction in infarct size/myocardium at risk. The aim of the present study is to confirm this finding in a larger multicenter trial.

The study is a randomized, controlled, evaluator blinded, multicenter trial enrolling 120 patients at ten sites.

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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:

    1. 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.
    2. 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.
  2. 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).
  3. Be a candidate for PCI and have PCI planned as the immediate intervention.
  4. 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.
  5. Be in Killips Class I.

Exclusion Criteria:

  1. Age less than eighteen (<18) years of age
  2. Age greater than or equal to eighty (80) years of age
  3. Are pregnant.
  4. Having an aortic dissection
  5. History of a prior large myocardial infarct or an infarct in the same segment that is currently affected.
  6. Acute administration of a thrombolytic agent for the qualifying MI
  7. Clinical suspicion of a non-thrombotic (e.g., pericarditis, vasospasm, takotsubo, illicit drug use) cause for ST-segment elevation as determined by the investigator
  8. 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.
  9. Known risk for heparin induced thrombocytopenia (HIT)
  10. Require an immediate surgical or procedural intervention other than PCI (e.g. CABG)
  11. Present in cardiogenic shock or with end-stage cardiomyopathy
  12. Have undergone at least ten (10) minutes of cardiopulmonary resuscitation (CPR) prior to presentation to the PCI facility
  13. History of surgical coronary artery revascularization (e.g. CABG)
  14. 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)
  15. Contraindications to hypothermia
  16. Personal or familial history of malignant hyperthermia
  17. Known end-stage renal disease (ESRD; e.g., on dialysis, or status-post renal transplant), known severe 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.).
  18. Serious concurrant medical condition likely to result in death during the next 12 months. 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.
  19. Contraindication to MRI (e.g., cardiac pacemaker, ICD, nerve stimulator, brain aneurysm clips, cochlear implants, claustrophobia)
  20. Deemed unsuitable by the investigators to participate in the study.
  21. Active or recent (within 1 month prior to study enrollment) participation in another investigational clinical research study.
  22. Enrollment in or planned to be enrolled in another study of AMI therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01379261

Locations
Austria
Graz University Hospital
Graz, Austria, A-8036
Innsbruck University Hospital
Innsbruck, Austria, A-6020
Medical University of Vienna
Vienna, Austria, A-1090
Denmark
Aarhus University Hospital
Aarhus, Denmark, DK-8200
Rigshospitalet - Copenhagen University Hospital
Copenhagen, Denmark, DK-2100
Slovenia
University Medical Centre
Ljubljana, Slovenia
Sweden
Sahlgrenska University Hospital
Gothenburg, Sweden
Skane University Hospital, Lund, Sweden
Lund, Sweden, 22185
Karolinska University Hospital
Stockholm, Sweden
Uppsala University Hospital
Uppsala, Sweden, 75185
Sponsors and Collaborators
Region Skane
Philips Healthcare
Lund University
Uppsala University
Investigators
Principal Investigator: 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
Study Director: Anthony Mullins Philips Healthcare, San Diego, CA, USA
Study Chair: Lars Wallentin, MD PhD Uppsala University Hospital, Uppsala, Sweden
  More Information

No publications provided by Region Skane

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT01379261     History of Changes
Other Study ID Numbers: CHILL-MI
Study First Received: June 21, 2011
Last Updated: April 4, 2013
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Region Skane:
STEMI
primary PCI
Hypothermia
Endovascular cooling
Cardiac MRI

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Reperfusion Injury
Myocardial Reperfusion Injury
Anterior Wall Myocardial Infarction
Inferior Wall Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Postoperative Complications
Cardiomyopathies

ClinicalTrials.gov processed this record on September 30, 2014