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Trial registered on ANZCTR


Registration number
ACTRN12613000242729
Ethics application status
Not yet submitted
Date submitted
13/02/2013
Date registered
28/02/2013
Date last updated
28/02/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Intracoronary Cooling (Evaluation of Outcomes) before Angioplasty Revascularisation in ST Elevation Myocardial Infarction
Scientific title
The effect of intracoronary hypothermia compared to normal standard of care on infarct size and muscle damage in patients who are having a STEMI caused by thrombus
Secondary ID [1] 281945 0
Nil
Universal Trial Number (UTN)
Trial acronym
ICEOBAR-STEMI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ST Elevation Myocardial Infarction 288360 0
Condition category
Condition code
Cardiovascular 288708 288708 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A cooling solution ( Sterile Ringers Lactate cooled to 0 degrees C and 10 degrees C) will be stored at this temperature (monitored fridge temp) and then transfered to an ice bath just before delivery to the patient. It will be given via infusion through a line set connected to the aspiration catheter and delivered directly into the coronary artery at a rate of 5.0ml +/- 2.5ml for a minimum of 5 minutes. This will occur before and after the thrombus has been removed.
Intervention code [1] 286508 0
Treatment: Other
Comparator / control treatment
In the control group the patients will be given the normal standard of care for a person experiencing a STEMI.
This consists of a coronary angiogram to repair the "culprit lesion" causing the STEMI. The treatment may include thrombus removal, baloon angioplasty, PCI or a combination of the three.
Control group
Active

Outcomes
Primary outcome [1] 288852 0
Reduction in myocardial damage - this will be measured by MRI
Timepoint [1] 288852 0
42 days post procedure
Secondary outcome [1] 301149 0
Time the first onset of chest pain or symptoms to being wheeled into the lab for coronary angioplasty
Timepoint [1] 301149 0
Time patient physically enters the lab for coronary angioplasty

Eligibility
Key inclusion criteria
Inclusion criteria
Patients who meet the following criteria may be included:
1. Age > then or = to 18 years
2. The patient (or next-of-kin or legal representative) provided written informed consent.
3. Clinical symptoms of ongoing ischemic chest pain and 12-lead ECG confirmation of acute STEMI, as defined by the following ECG criteria present upon arrival to the PCI lab:
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 - V6; and/or >0.1mV in leads I, AVL.
OR
b. Higher-risk inferior infarct: ST elevation >0.2mV measured 0.08 sec after the J point in 2 or more anatomically contiguous inferior leads II, III, AVF, and ST depression>0.1mV in 2 or more contiguous anterior leads,
4. Present to the study PCI lab within eight (8) hours of the onset of acute cardiac ischemic symptoms (such as chest pain or pressure, arm or jaw pain, dyspnea).
5. Be a candidate for primary PCI and have PCI planned as the immediate intervention.
6. Be willing and able to comply with study procedures, including returning for the cardiac MRI scan at 3+/-1 days post-procedure and be available for additional follow up.
7. Target coronary artery is completely or nearly completed occluded at angiography prior to PCI (TIMI 0 or 1 flow).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria
Patients who meet any one of these criteria will be excluded from the investigation:
1. Is or may be pregnant.
2. Prior myocardial infarct in the same coronary distribution
3. Known pre-existing LV dysfunction (LVEF< 40%)
4. Administration of a thrombolytic agent for the qualifying MI
5. History of mental illness
6. Clinical suspicion of a non-thrombotic cause for ST-segment elevation (e.g., pericarditis, vasospasm, takotsubo cardiomyopathy, illicit drug use)
7. Allergy or contraindication to heparin, aspirin or thienopyridines
8. Requires an immediate surgical or procedural intervention other than PCI (e.g. CABG)
9. Presents in cardiogenic shock
10. Has undergone at least 10 minutes of cardiopulmonary resuscitation (CPR) prior to presentation to the PCI facility, or have ongoing ventricular arrhythmias
11. History of surgical coronary artery revascularization (e.g. CABG)
12. Active bleeding, coagulopathy within previous 3 months
13. Known significant renal disease (on dialysis, post renal transplant or eGFR<30), known severe hepatic failure (e.g., cirrhosis, or acute hepatitis)
14. Serious concurrent medical condition likely to result in death during the next 12 months.
15. Contraindication to MRI (e.g., cardiac pacemaker, ICD, nerve stimulator, brain aneurysm clips, cochlear implants, claustrophobia)
16. Participation in another investigational clinical research study that has not reached its primary endpoint
17. The investigator determines that a patient is not a good candidate for the study despite having met all the eligibility criteria.
18. TIMI 2 or 3 flow in the target coronary artery

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be admitted to hospital as having or having had a STEMI. After inclusion criteria has been met, patients will be approached about participation. A PICF will be given to patients, after time to consider, patients will agree or delcine to participate.
If they agree, they will be consented to the trial by a delegated trial member - normally PI or SI.
ALlocation concealment will involve contacting the holder of the allocation schedule who is "off-site" or at a central administration site.
The the patient will then be randomised by 2:1 by computer generated pseudo-random number.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
randomised by 2:1 by computer generated pseudo-random number
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Sample size will be a maximum of 27 patients. 18 to the hypothermia group and 9 in the control group. The trial is not powered to detect a clinically relevant difference in treatment groups. Primary objective is safety and feasibility and treatment effect.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Paired t-test

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/03/2013
Actual
Date of last participant enrolment
Anticipated
16/12/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
27
Accrual to date
Final
Recruitment outside Australia
Country [1] 4861 0
New Zealand
State/province [1] 4861 0
Auckland

Funding & Sponsors
Funding source category [1] 286724 0
Commercial sector/Industry
Name [1] 286724 0
Prospex Medical III Inc
Country [1] 286724 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Prospex Medical III Inc
Address
900 Long Lake Road
Suite 250
New Brighton
MN 55112
Country
United States of America
Secondary sponsor category [1] 285499 0
None
Name [1] 285499 0
Address [1] 285499 0
Country [1] 285499 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 288796 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 288796 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington 6011
Ethics committee country [1] 288796 0
New Zealand
Date submitted for ethics approval [1] 288796 0
14/02/2013
Approval date [1] 288796 0
Ethics approval number [1] 288796 0

Summary
Brief summary
The aim of treatment in a heart attack is to open the blocked coronary vessel causing the heart attack and return normal blood flow to the heart muscle as soon as possible. Despite this, many patients can suffer damage to the heart muscle. Hypothermia or cooling is predicted to reduce the extent of the heart muscle damage. Cooling fluid is infused via a catheter and delivered to the arteries that supply blood to the heart. This slows the heart muscle activity and reduces the amount of blood supply required for heart function. This cooling procedure is also proposed to help in the same way when normal blood flow is returned to the heart.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes
N/A

Contacts
Principal investigator
Name 37818 0
Dr Mark Webster
Address 37818 0
Auckland City Hospital
2 Park Road
Private Bag 92-024
Grafton
Auckland 1023
Country 37818 0
New Zealand
Phone 37818 0
+64 9 3074949 ext 23665
Fax 37818 0
Email 37818 0
[email protected]
Contact person for public queries
Name 37819 0
Donna Katae
Address 37819 0
Auckland City Hospital
2 Park Road
Private Bag 92-024
Grafton
Auckland 1023
Country 37819 0
New Zealand
Phone 37819 0
+64 9 3074949 ext 24389
Fax 37819 0
Email 37819 0
[email protected]
Contact person for scientific queries
Name 37820 0
Jason Galdonik
Address 37820 0
900 Long Lake Road
Suite 250
New Brighton
MN 55112
Country 37820 0
United States of America
Phone 37820 0
+1 651 207 4717
Fax 37820 0
Email 37820 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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