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

August 18, 2020 updated by: ZOLL Circulation, Inc., USA

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Lund, Sweden
        • Department of Cardiology, Lund University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: patients with acute STEMI - treatment with Hypothermia +PCI

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).
Device: Endovascular cooling by the Celsius Control System
Active Comparator: Patients with an acute STEMI eligible for primary PCI
Standard of care treatment or the control group Patients with an acute STEMI eligible for primary PCI
Other: Standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac MRI infarct size
Time Frame: Day 4
reduction in infarct size as a percentage of left ventricle size in the per protocol population.
Day 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRI infarct size
Time Frame: Day 4
Infarct size as percent of area at risk determined with T2-weighted MRI in per protocol population
Day 4
Myocardial necrosis
Time Frame: 24 Hours
CK-MB release through 24 hours as area under the curve
24 Hours
NYHA/AHA Cardiac Functional Class
Time Frame: Day 30
used to describe stages of Heart Failure ( Class I, II, III and IV)
Day 30
Major Adverse Cardiac Events (MACE)
Time Frame: Month 12
MACE: Death, MI, re-hospitalization
Month 12
Angiographic outcomes
Time Frame: Day 1
TIMI flow grade, TIMI myocardial perfusion grade
Day 1
ST-segment resolution
Time Frame: Day 1
ST-segment resolution as a function of time
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ZOLL Circulation, Inc., USA

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

January 2, 2007

First Submitted That Met QC Criteria

January 2, 2007

First Posted (Estimate)

January 4, 2007

Study Record Updates

Last Update Posted (Actual)

August 20, 2020

Last Update Submitted That Met QC Criteria

August 18, 2020

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rapid MI-ICE-Pilot

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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