Therapeutic Effect of Local Hypothermia in Treatment of Acute Myocardial Infarction

January 6, 2017 updated by: The First Affiliated Hospital with Nanjing Medical University

Effect of Local Myocardial Hypothermia on Outcomes in Patients With Acute Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Ethics and organization The study was designed in agreement with the Declaration of Nanjing, and the study protocol was approved by the local ethics committees. A written informed consent will be completed before inclusion. The trial was coordinated and monitored by the First Affiliated Hospital with Nanjing Medical University. An independent data and safety monitoring board, including of physicians independent of the trial sponsor and operational leadership, monitored the safety of the study.

Study population From March 2017 to March 2019, 300 patients from department of cardiology (the First Affiliated Hospital with Nanjing Medical University, Nanjing, China) will be enrolled in this prospective, randomized, end point-blinded study to evaluate the local hypothermia as an adjunct therapy in patients with acute myocardial infarction (AMI) eligible for primary percutaneous intervention (PPCI). Men and women ages 40 and 80 years presenting with anterior or non-anterior AMIs with ST-segment elevation>0.2 mV in 2 contiguous leads and a duration of symptoms<12h will be included. We will collect a second electrocardiogram in the catheterization laboratory before randomization to ensure persistent ST-segment elevation. We conduct the exclusive criterion, including patients with previous AMIs, previous PCI or coronary artery bypass grafting, congestive heart failure, end-stage kidney disease or hepatic failure, recent stroke, coagulopathy, pregnancy, cardiac arrest, or Killip class II to IV at presentation.

Protocol. The AMI patients will be randomized 1:1 to hypothermia or standard of care before coronary angiography. Using varying block sizes and stratification, we generate the randomization list by computer. A standard working guide-wire, Runthrough NS (Terumo Corporation, Japan), is advanced into the distal part of the target coronary artery after determining of the criminal vessel by using angiography. Compared to the standard PPCI after the balloon expansion, the aspirated catheter (Diver C.E. MAX, Invatec S.p.A, 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). Loading doses of 300 mg of aspirin, 180 mg ticagrelor and heparin (100u/kg) will be given to all patients before cardiac catheterization. Glycoprotein IIb/IIIa inhibitors, bivalirudin and sodium nitroprusside will be administered at the discretion of the treating physician.

Measurements To analyze the ventricular dimensions, myocardium at risk (MaR) and infarct size, using postprocessing software, patients will be allocated to undergo cardiac magnetic resonance examinations at the core laboratory (the First Affiliated Hospital with Nanjing Medical University, Nanjing, China).

Troponin T/I, myoglobin, and creatine kinase-MB will be sampled before randomization and at 12 and 24 h after catheterization. We define the peak values as the highest measured values within 24 h by calculating under area of the curve from the measurements. N-terminal pro-brain natriuretic peptide will be sampled and dynamic electrocardiogram be performed at 48h after admission.

Clinical endpoints. Clinical events will be collected using a clinical report form during the index hospital stay, at 30±10 days, and at 12 months. Furthermore, adverse event and serious adverse event reporting will be collected as clinical endpoints. The independent monitors supervise hospital charts for all patients. All primary events (death, re-infarction, target lesion revascularization, major bleeding and heart failure) will be assessed independently by a blinded clinical events committee.

Statistical analysis. Calculations and statistics will be performed by using the GraphPad Prism 5.0 software (GraphPad Software Inc, La Jolla, Calif). The Fisher exact test will be performed on categorical variables. Continuous variables will be tested using Mann-Whitney Utest with exact inference. Statistical significance will be conducted at P<0.05.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Infarct Size
Time Frame: The Infarct Size of Myocardial Is Measured by Magnetic Resonance Imaging in Day 7.
The Infarct Size of Myocardial Is Measured by Magnetic Resonance Imaging in Day 7.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Investigators

  • Principal Investigator: Lian-Sheng Wang, MD, PhD, The First Affiliated Hospital with Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2017

Primary Completion (Anticipated)

March 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

January 6, 2017

First Submitted That Met QC Criteria

January 6, 2017

First Posted (Estimate)

January 9, 2017

Study Record Updates

Last Update Posted (Estimate)

January 9, 2017

Last Update Submitted That Met QC Criteria

January 6, 2017

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LS-81570363

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Myocardial Infarction

Clinical Trials on Infusion of Cold Saline into Local Infarction Myocardium.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burundi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe