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Therapeutic Effect of Local Hypothermia in Treatment of Acute Myocardial Infarction

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified December 2016 by The First Affiliated Hospital with Nanjing Medical University
Sponsor:
Information provided by (Responsible Party):
The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT03015155
First received: January 6, 2017
Last updated: NA
Last verified: December 2016
History: No changes posted
  Purpose
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.

Condition Intervention
Acute Myocardial Infarction Procedure: Infusion of Cold Saline into Local Infarction Myocardium.

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Local Myocardial Hypothermia on Outcomes in Patients With Acute Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention.

Resource links provided by NLM:


Further study details as provided by The First Affiliated Hospital with Nanjing Medical University:

Primary Outcome Measures:
  • Infarct Size [ Time Frame: The Infarct Size of Myocardial Is Measured by Magnetic Resonance Imaging in Day 7. ]

Estimated Enrollment: 300
Study Start Date: March 2017
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hypothermia
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03015155

Contacts
Contact: Lian-Sheng Wang, MD, PhD 0086-25-83724440 drlswang@njmu.edu.cn

Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University
Investigators
Principal Investigator: Lian-Sheng Wang, MD, PhD The First Affiliated Hospital with Nanjing Medical University
  More Information

Publications:

Responsible Party: The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier: NCT03015155     History of Changes
Other Study ID Numbers: LS-81570363
Study First Received: January 6, 2017
Last Updated: January 6, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Hypothermia
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on August 22, 2017