Therapeutic Effect of Local Hypothermia in Treatment of Acute Myocardial Infarction

NCT03015155 | Unknown DMC

• 1 other identifier: LS-81570363
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

Recent clinical studies have shown that systemic therapeutic hypothermia improving the outcomes in patients with ST segment elevated myocardial infarction (STEMI) received primary percutaneous coronary intervention (P-PCI).Likewise, a few in vivo animal experiments have described the methods, mechanism and rationale of therapeutic hypothermia, including local myocardial hypothermia. However, little is known of the local myocardial hypothermia having impact on prognosis of the patients with acute myocardial infarction. The aim of this study is to ascertain whether local myocardial hypothermia is effective in treatment of ischemia/reperfusion injury in patients with STEMI undergoing P-PCI.

Conditions

Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Infarct Size

  The Infarct Size of Myocardial Is Measured by Magnetic Resonance Imaging in Day 7.

Study Arms (2)

Hypothermia

EXPERIMENTAL

Infusion of Cold Saline into Local Infarction Myocardium. A standard working guide-wire, Runthrough NS (Terumo, Japan), is advanced into the distal part of the target coronary artery by using angiography. Compared to the standard PPCI after the balloon expansion, the aspirated catheter (Diver C.E. MAX, Italy) is firstly placed at the location of the distal occlusion lesion to achieve local myocardial hypothermia by infusing the cold saline (4℃, 2.5ml/min, 5min). Then we retract the aspirated catheter, following the balloon expansion and the drug eluting stent implanting. Subsequently, the infusion catheter is tautologically placed at the location of the opened occlusion, within the stent, to persistently perfuse the infarct myocardium with cold saline (4℃, 2.5ml/min, 15min).

Procedure: Infusion of Cold Saline into Local Infarction Myocardium.

Standard treatment

NO INTERVENTION

We place a standard working guide-wire, Runthrough NS (Terumo Corporation, Japan), crossover the criminal lesion of to the distal of the target coronary artery after angiography. Then the pre-dilated balloon is placed at the occluded lesion site to expand the criminal vessel without hypothermia intervention. The operation will be completed when the flow of target coronary artery achieves TIMI class 3 after the drug eluting stent implanting.

Interventions

Infusion of Cold Saline into Local Infarction Myocardium. PROCEDURE

Infusion of Cold Saline into the Area of Ischemic Myocardium by Using Aspirated Catheter Before the Ischemia/reperfusion.

Hypothermia

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who present with an anterior or inferior STEMI with ST-segment elevation of 0.2 mV in \>2 or more anatomically contiguous leads and a duration of symptoms of \<6 hours are included.

You may not qualify if:

• Participants with cardiac arrest, previous AMI, previous PCI or CABG, known congestive heart failure, end-stage kidney disease or hepatic failure, coagulopathy, pregnancy, or Killip class II through IV at presentation are excluded in this study.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Related Publications (8)

• 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: 25985169 BACKGROUND

• Villablanca PA, Rao G, Briceno DF, Lombardo M, Ramakrishna H, Bortnick A, Garcia M, Menegus M, Sims D, Makkiya M, Mookadam F. Therapeutic hypothermia in ST elevation myocardial infarction: a systematic review and meta-analysis of randomised control trials. Heart. 2016 May;102(9):712-9. doi: 10.1136/heartjnl-2015-308559. Epub 2016 Feb 10.

  PMID: 26864673 BACKGROUND

• Kohlhauer M, Berdeaux A, Ghaleh B, Tissier R. Therapeutic hypothermia to protect the heart against acute myocardial infarction. Arch Cardiovasc Dis. 2016 Dec;109(12):716-722. doi: 10.1016/j.acvd.2016.05.005. Epub 2016 Sep 28.

  PMID: 27692660 BACKGROUND

• Kim H, Lee J, Song W, Shin J, Oh D, Harrison K, Jakkula M, Wong SC, Hong MK. Feasibility and safety of regional myocardial hypothermia during myocardial ischemia and infarction in pigs. Coron Artery Dis. 2005 Mar;16(2):125-9. doi: 10.1097/00019501-200503000-00008.

  PMID: 15735406 RESULT

• Otake H, Shite J, Paredes OL, Shinke T, Yoshikawa R, Tanino Y, Watanabe S, Ozawa T, Matsumoto D, Ogasawara D, Yokoyama M. Catheter-based transcoronary myocardial hypothermia attenuates arrhythmia and myocardial necrosis in pigs with acute myocardial infarction. J Am Coll Cardiol. 2007 Jan 16;49(2):250-60. doi: 10.1016/j.jacc.2006.06.080. Epub 2006 Dec 29.

  PMID: 17222738 RESULT

• Otterspoor LC, Van't Veer M, van Nunen LX, Wijnbergen I, Tonino PA, Pijls NH. Safety and feasibility of local myocardial hypothermia. Catheter Cardiovasc Interv. 2016 Apr;87(5):877-83. doi: 10.1002/ccd.26139. Epub 2015 Aug 13.

  PMID: 26269225 RESULT

• 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.

  PMID: 24509284 RESULT

• Dixon SR, Whitbourn RJ, Dae MW, Grube E, Sherman W, Schaer GL, Jenkins JS, Baim DS, Gibbons RJ, Kuntz RE, Popma JJ, Nguyen TT, O'Neill WW. Induction of mild systemic hypothermia with endovascular cooling during primary percutaneous coronary intervention for acute myocardial infarction. J Am Coll Cardiol. 2002 Dec 4;40(11):1928-34. doi: 10.1016/s0735-1097(02)02567-6.

  PMID: 12475451 RESULT

Study Officials

• Lian-Sheng Wang, MD, PhD

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lian-Sheng Wang, MD, PhD

CONTACT

0086-25-83724440; drlswang@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2017
• First Posted: January 9, 2017
• Study Start: March 1, 2017
• Primary Completion: March 1, 2019
• Study Completion: December 1, 2019
• Last Updated: January 9, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share