Efficacy of Endovascular Catheter Cooling Combined With Cold Saline for the Treatment of Acute Myocardial Infarction
NCT ID: NCT01379261
Last Updated: 2014-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2/PHASE3
120 participants
INTERVENTIONAL
2011-06-30
2013-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Rapid Intravascular Cooling in Myocardial Infarction as Adjunctive to Percutaneous Coronary Intervention
NCT00417638
STEMI Cool Pilot Trial to Assess Cooling as an Adjunctive Therapy to PCI In Patients With Acute MI (Phase A)
NCT03361995
EUROpean Intracoronary Cooling Evaluation in Patients With ST-elevation Myocardial Infarction.
NCT03447834
Efficacy and Safety of Prehospital Administration of Bivalirudin in STEMI Patients
NCT00391326
Primary Angioplasty for Acute Myocardial Infarction in Patients With Symptom Duration Above 12 Hours
NCT00260416
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The study is a randomized, controlled, evaluator blinded, multicenter trial enrolling 120 patients at ten sites.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Hypothermia treatment
1-2 liters of cold saline and central venous catheter cooling with Philips InnerCool RTx Endovascular System prior to PCI
Cooling
1-2 liters of cold saline and central venous catheter cooling with Philips InnerCool RTx Endovascular System prior to PCI
Standard treatment
Standard treatment
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cooling
1-2 liters of cold saline and central venous catheter cooling with Philips InnerCool RTx Endovascular System prior to PCI
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. 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. Inferior infarct: ST elevation \>0.2mV measured 0.08 sec after the J point in 2 or more anatomically contiguous inferior leads, coupled with ST depression in 2 contiguous anterior leads for a total ST deviation (inferior ST elevation plus anterior ST depression) of \>0.8mV.
2. Present to the study PCI lab 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 be available for additional follow up Subject understands study procedures and agrees to participate in the study by giving written informed consent.
5. Be in Killips Class I.
Exclusion Criteria
2. Age greater than or equal to eighty (80) years of age
3. Are pregnant.
4. Having an aortic dissection
5. History of a prior large myocardial infarct or an infarct in the same segment that is currently affected.
6. Acute administration of a thrombolytic agent for the qualifying MI
7. Clinical suspicion of a non-thrombotic (e.g., pericarditis, vasospasm, takotsubo, illicit drug use) cause for ST-segment elevation as determined by the investigator
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. Known risk for heparin induced thrombocytopenia (HIT)
10. Require an immediate surgical or procedural intervention other than PCI (e.g. CABG)
11. Present in cardiogenic shock or with end-stage cardiomyopathy
12. Have undergone at least ten (10) minutes of cardiopulmonary resuscitation (CPR) prior to presentation to the PCI facility
13. History of surgical coronary artery revascularization (e.g. CABG)
14. 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)
15. Contraindications to hypothermia
16. Personal or familial history of malignant hyperthermia
17. Known end-stage renal disease (ESRD; e.g., on dialysis, or status-post renal transplant), known severe 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.).
18. Serious concurrant medical condition likely to result in death during the next 12 months. 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.
19. Contraindication to MRI (e.g., cardiac pacemaker, ICD, nerve stimulator, brain aneurysm clips, cochlear implants, claustrophobia)
20. Deemed unsuitable by the investigators to participate in the study.
21. Active or recent (within 1 month prior to study enrollment) participation in another investigational clinical research study.
22. Enrollment in or planned to be enrolled in another study of AMI therapy
18 Years
79 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Philips Healthcare
INDUSTRY
Lund University
OTHER
Uppsala University
OTHER
Region Skane
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
David Erlinge, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Cardiology, Skane University Hospital, Lund, Sweden
Göran K Olivecrona, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Cardiology, Skane University Hospital, Lund, Sweden
Anthony Mullins
Role: STUDY_DIRECTOR
Philips Healthcare, San Diego, CA, USA
Lars Wallentin, MD PhD
Role: STUDY_CHAIR
Uppsala University Hospital, Uppsala, Sweden
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Graz University Hospital
Graz, , Austria
Innsbruck University Hospital
Innsbruck, , Austria
Medical University of Vienna
Vienna, , Austria
Aarhus University Hospital
Aarhus, , Denmark
Rigshospitalet - Copenhagen University Hospital
Copenhagen, , Denmark
University Medical Centre
Ljubljana, , Slovenia
Sahlgrenska University Hospital
Gothenburg, , Sweden
Skane University Hospital, Lund, Sweden
Lund, , Sweden
Karolinska University Hospital
Stockholm, , Sweden
Uppsala University Hospital
Uppsala, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Nordlund D, Heiberg E, Carlsson M, Frund ET, Hoffmann P, Koul S, Atar D, Aletras AH, Erlinge D, Engblom H, Arheden H. Extent of Myocardium at Risk for Left Anterior Descending Artery, Right Coronary Artery, and Left Circumflex Artery Occlusion Depicted by Contrast-Enhanced Steady State Free Precession and T2-Weighted Short Tau Inversion Recovery Magnetic Resonance Imaging. Circ Cardiovasc Imaging. 2016 Jul;9(7):e004376. doi: 10.1161/CIRCIMAGING.115.004376.
Engblom H, Tufvesson J, Jablonowski R, Carlsson M, Aletras AH, Hoffmann P, Jacquier A, Kober F, Metzler B, Erlinge D, Atar D, Arheden H, Heiberg E. A new automatic algorithm for quantification of myocardial infarction imaged by late gadolinium enhancement cardiovascular magnetic resonance: experimental validation and comparison to expert delineations in multi-center, multi-vendor patient data. J Cardiovasc Magn Reson. 2016 May 4;18(1):27. doi: 10.1186/s12968-016-0242-5.
Tufvesson J, Carlsson M, Aletras AH, Engblom H, Deux JF, Koul S, Sorensson P, Pernow J, Atar D, Erlinge D, Arheden H, Heiberg E. Automatic segmentation of myocardium at risk from contrast enhanced SSFP CMR: validation against expert readers and SPECT. BMC Med Imaging. 2016 Mar 5;16:19. doi: 10.1186/s12880-016-0124-1.
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.
Erlinge D, Gotberg M, Lang I, Holzer M, Noc M, Clemmensen P, Jensen U, Metzler B, James S, Botker HE, Omerovic E, Engblom H, Carlsson M, Arheden H, Ostlund O, Wallentin L, Harnek J, Olivecrona GK. Rapid endovascular catheter core cooling combined with cold saline as an adjunct to percutaneous coronary intervention for the treatment of acute myocardial infarction. The CHILL-MI trial: a randomized controlled study of the use of central venous catheter core cooling combined with cold saline as an adjunct to percutaneous coronary intervention for the treatment of acute myocardial infarction. J Am Coll Cardiol. 2014 May 13;63(18):1857-65. doi: 10.1016/j.jacc.2013.12.027. Epub 2014 Feb 5.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CHILL-MI
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.