Therapeutic Effect of Local Hypothermia in Treatment of Acute Myocardial Infarction
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|ClinicalTrials.gov Identifier: NCT03015155|
Recruitment Status : Unknown
Verified December 2016 by The First Affiliated Hospital with Nanjing Medical University.
Recruitment status was: Not yet recruiting
First Posted : January 9, 2017
Last Update Posted : January 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Acute Myocardial Infarction||Procedure: Infusion of Cold Saline into Local Infarction Myocardium.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Effect of Local Myocardial Hypothermia on Outcomes in Patients With Acute Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention.|
|Study Start Date :||March 2017|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||December 2019|
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.
Infusion of Cold Saline into the Area of Ischemic Myocardium by Using Aspirated Catheter Before the Ischemia/reperfusion.
No Intervention: Standard treatment
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.
- Infarct Size [ Time Frame: The Infarct Size of Myocardial Is Measured by Magnetic Resonance Imaging in Day 7. ]
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03015155
|Contact: Lian-Sheng Wang, MD, PhDemail@example.com|
|Principal Investigator:||Lian-Sheng Wang, MD, PhD||The First Affiliated Hospital with Nanjing Medical University|