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

Primary Purpose

Acute Anterior Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Endovascular cooling by the Celsius Control System
Standard of care
Sponsored by
ZOLL Circulation, Inc., USA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Anterior Myocardial Infarction focused on measuring myocardial infarction, acute intervention, percutaneous intervention, endovascular cooling, endovascular rewarming

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Cardiology, Lund University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

patients with acute STEMI - treatment with Hypothermia +PCI

Patients with an acute STEMI eligible for primary PCI

Arm Description

Hypothermia 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).

Standard of care treatment or the control group Patients with an acute STEMI eligible for primary PCI

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

MRI infarct size
Infarct size as percent of area at risk determined with T2-weighted MRI in per protocol population
Myocardial necrosis
CK-MB release through 24 hours as area under the curve
NYHA/AHA Cardiac Functional Class
used to describe stages of Heart Failure ( Class I, II, III and IV)
Major Adverse Cardiac Events (MACE)
MACE: Death, MI, re-hospitalization
Angiographic outcomes
TIMI flow grade, TIMI myocardial perfusion grade
ST-segment resolution
ST-segment resolution as a function of time

Full Information

First Posted
January 2, 2007
Last Updated
August 18, 2020
Sponsor
ZOLL Circulation, Inc., USA
Collaborators
Lund University Hospital, Philips Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT00417638
Brief Title
Rapid Intravascular Cooling in Myocardial Infarction as Adjunctive to Percutaneous Coronary Intervention
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ZOLL Circulation, Inc., USA
Collaborators
Lund University Hospital, Philips Healthcare

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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) in patients with an occluded infarct-related artery.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Anterior Myocardial Infarction
Keywords
myocardial infarction, acute intervention, percutaneous intervention, endovascular cooling, endovascular rewarming

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients with acute STEMI - treatment with Hypothermia +PCI
Arm Type
Experimental
Arm Description
Hypothermia 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).
Arm Title
Patients with an acute STEMI eligible for primary PCI
Arm Type
Active Comparator
Arm Description
Standard of care treatment or the control group Patients with an acute STEMI eligible for primary PCI
Intervention Type
Device
Intervention Name(s)
Endovascular cooling by the Celsius Control System
Intervention Type
Other
Intervention Name(s)
Standard of care
Primary Outcome Measure Information:
Title
Cardiac MRI infarct size
Description
reduction in infarct size as a percentage of left ventricle size in the per protocol population.
Time Frame
Day 4
Secondary Outcome Measure Information:
Title
MRI infarct size
Description
Infarct size as percent of area at risk determined with T2-weighted MRI in per protocol population
Time Frame
Day 4
Title
Myocardial necrosis
Description
CK-MB release through 24 hours as area under the curve
Time Frame
24 Hours
Title
NYHA/AHA Cardiac Functional Class
Description
used to describe stages of Heart Failure ( Class I, II, III and IV)
Time Frame
Day 30
Title
Major Adverse Cardiac Events (MACE)
Description
MACE: Death, MI, re-hospitalization
Time Frame
Month 12
Title
Angiographic outcomes
Description
TIMI flow grade, TIMI myocardial perfusion grade
Time Frame
Day 1
Title
ST-segment resolution
Description
ST-segment resolution as a function of time
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Goran K Olivecrona, MD
Organizational Affiliation
Department of Cardiology, Lund University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Erlinge, MD, PhD
Organizational Affiliation
Department of Cardiology, Lund University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiology, Lund University Hospital
City
Lund
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
25985169
Citation
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.
Results Reference
derived
PubMed Identifier
23164721
Citation
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.
Results Reference
derived
PubMed Identifier
20736446
Citation
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.
Results Reference
derived

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

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