NCT00417638

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 2, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2007

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

August 20, 2020

Status Verified

January 1, 2010

Enrollment Period

2.8 years

First QC Date

January 2, 2007

Last Update Submit

August 18, 2020

Conditions

Acute Anterior Myocardial Infarction

Keywords

myocardial infarctionacute interventionpercutaneous interventionendovascular coolingendovascular rewarming

Outcome Measures

Primary Outcomes (1)

  • Cardiac MRI infarct size

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

    Day 4

Secondary Outcomes (6)

  • MRI infarct size

    Day 4

  • Myocardial necrosis

    24 Hours

  • NYHA/AHA Cardiac Functional Class

    Day 30

  • Major Adverse Cardiac Events (MACE)

    Month 12

  • Angiographic outcomes

    Day 1

  • +1 more secondary outcomes

Study Arms (2)

patients with acute STEMI - treatment with Hypothermia +PCI

EXPERIMENTAL

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

Patients with an acute STEMI eligible for primary PCI

ACTIVE COMPARATOR

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

Other: Standard of care

Interventions

Endovascular cooling by the Celsius Control SystemDEVICE
patients with acute STEMI - treatment with Hypothermia +PCI
Standard of careOTHER
Patients with an acute STEMI eligible for primary PCI

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, Lund University Hospital

Lund, Sweden

Location

Related Publications (3)

  • 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.

    PMID: 25985169DERIVED

  • 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.

    PMID: 23164721DERIVED

  • 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.

    PMID: 20736446DERIVED

MeSH Terms

Conditions

Anterior Wall Myocardial InfarctionMyocardial Infarction

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Goran K Olivecrona, MD

    Department of Cardiology, Lund University Hospital

    PRINCIPAL INVESTIGATOR

  • David Erlinge, MD, PhD

    Department of Cardiology, Lund University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2007

First Posted

January 4, 2007

Study Start

January 1, 2007

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

August 20, 2020

Record last verified: 2010-01

Locations

SE(1)