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

June 21, 2011
April 4, 2013
June 2011
April 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01379261 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 the composite of death, heart failure, recurrent MI, emergent stent revascularisation or any hospitalisation at 45±15 days and 6 months. [ Time Frame: At 4±2 days ] [ 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, pulmonary oedema, infections and bleeding (TIMI definition) within 45±15 days. [ Time Frame: 45±15 days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Efficacy of Endovascular Catheter Cooling Combined With Cold Saline for the Treatment of Acute Myocardial Infarction
Rapid Endovascular Catheter Core Cooling Combined With Cold Saline as an Adjunct to Percutaneous Coronary Intervention For the Treatment of Acute Myocardial Infarction

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Myocardial Infarction
  • Myocardial Reperfusion Injury
  • Anterior Wall Myocardial Infarction
  • Inferior Wall Myocardial Infarction
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
  • Active Comparator: Hypothermia treatment
    1-2 liters of cold saline and central venous catheter cooling with Philips InnerCool RTx Endovascular System prior to PCI
    Intervention: Procedure: Cooling
  • No Intervention: Standard treatment
    Standard treatment

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
120
August 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Denmark,   Slovenia,   Sweden
 
NCT01379261
CHILL-MI
Yes
Region Skane
Region Skane
  • Philips Healthcare
  • Lund University
  • Uppsala University
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
Region Skane
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP