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

Acute Anterior Myocardial Infarction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00417638
• Other study ID #: Rapid MI-ICE-Pilot
• Status: Completed
• Phase: N/A
• Start date: January 2007
• Est. completion date: October 2009

Study information

• Verified date: January 2010
• Source: ZOLL Circulation, Inc., USA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Anterior Myocardial Infarction
• Anterior Wall Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Device:
• Endovascular cooling by the Celsius Control System

Other:
• Standard of care

Locations

Country	Name	City	State
Sweden	Department of Cardiology, Lund University Hospital	Lund

Sponsors (3)

Lead Sponsor	Collaborator
ZOLL Circulation, Inc., USA	Lund University Hospital, Philips Healthcare

Country where clinical trial is conducted

Sweden, 

Outcome

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