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

This study has been completed.
Sponsor:
Collaborator:
Lund University Hospital
Information provided by:
Philips Healthcare
ClinicalTrials.gov Identifier:
NCT00417638
First received: January 2, 2007
Last updated: January 14, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention
Acute Anterior Myocardial Infarction
Device: Endovascular cooling by the Celsius Control System
Other: Standard of care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Philips Healthcare:

Primary Outcome Measures:
  • Cardiac MRI infarct size as a percentage of left ventricle size in the per protocol population. [ Time Frame: Day 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • MRI infarct size as percent of area at risk determined with T2-weighted MRI in per protocol population [ Time Frame: Day 4 ] [ Designated as safety issue: No ]
  • Myocardial necrosis: CK-MB release through 24 hours as area under the curve [ Time Frame: 24 Hours ] [ Designated as safety issue: No ]
  • NYHA/AHA Cardiac Functional Class [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
  • MACE: Death, MI, re-hospitalization [ Time Frame: Month 12 ] [ Designated as safety issue: Yes ]
  • Angiographic outcomes (TIMI flow grade, TIMI myocardial perfusion grade) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • ST-segment resolution as a function of time [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: January 2007
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Hypothermia using endovascular cooling with the Celsius Control System
Device: Endovascular cooling by the Celsius Control System
Active Comparator: 2
Standard of care treatment
Other: Standard of care

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Each eligible patient must meet the following inclusion criteria :

  1. 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
  2. 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)
  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 return for the clinical examination on Day 30
  5. Provide written informed consent prior to the initiation of study-specific procedures
  6. Be in Killips Class I

Exclusion Criteria:

Patients are not eligible for the study if they meet one or more of the following criteria:

  1. Age less than eighteen (<18) years of age
  2. Age greater than seventy-five (>75) years of age
  3. Are pregnant
  4. Have a suspected aortic dissection
  5. History of a prior anterior myocardial infarct or prior large myocardial infarct.
  6. The suspected etiology of myocardial infarction is primarily related to substance abuse (e.g., cocaine, methamphetamine, etc.)
  7. Acute administration of a thrombolytic agent for the qualifying MI
  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. Require an immediate surgical or procedural intervention other than PCI (e.g. CABG)
  10. Present in cardiogenic shock or with end-stage cardiomyopathy
  11. Have undergone at least ten (10) minutes of cardiopulmonary resuscitation (CPR) prior to presentation to the PCI facility
  12. History of previous MI with known, pre-existing, anterior pathologic Q-waves
  13. History of surgical coronary artery revascularization (e.g., CABG, MIDCAB, or OPCAB)
  14. Recent stroke (within 3 months)
  15. 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)
  16. 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)
  17. Personal or familial history of malignant hyperthermia
  18. 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.]
  19. 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
  20. Deemed unsuitable by the investigators to participate in the study.
  21. Signs of cardiogenic shock or other signs of significant heart failure such as rales over the lungs
  22. Active or recent (within 1 month prior to study enrollment) participation in another investigational clinical research study
  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: NCT00417638

Locations
Sweden
Department of Cardiology, Lund University Hospital
Lund, Sweden
Sponsors and Collaborators
Philips Healthcare
Lund University Hospital
Investigators
Principal Investigator: Goran K Olivecrona, MD Department of Cardiology, Lund University Hospital
Principal Investigator: David Erlinge, MD, PhD Department of Cardiology, Lund University Hospital
  More Information

No publications provided by Philips Healthcare

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Goran K Olivecrona, MD, Lund University Hospital
ClinicalTrials.gov Identifier: NCT00417638     History of Changes
Other Study ID Numbers: Rapid MI-ICE-Pilot
Study First Received: January 2, 2007
Last Updated: January 14, 2010
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Philips Healthcare:
myocardial infarction
acute intervention
percutaneous intervention
endovascular cooling
endovascular rewarming

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Anterior Wall Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 29, 2014