Safety and Feasibility of Intracoronary Hypothermia in Acute Myocardial Infarction (SINTAMI)

November 19, 2016 updated by: Luuk Otterspoor, Catharina Ziekenhuis Eindhoven

Hypothermia may reduce infarct size in patients with acute myocardial infarction if provided before reperfusion. Human studies using systemic cooling methods failed to show a reduction in infarction size. The use of selective intracoronary hypothermia may overcome the problems of systemic cooling.

The hypothesis of this study is that in patients with acute myocardial infarction, the induction of intracoronary hypothermia is safe and feasible.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In acute myocardial infarction, infarct size is directly related to short and long-term mortality and development of chronic heart failure.Therefore, limiting infarct size is of great worth. Therapies to reduce ischemic injury, by primarily primary percutaneous coronary intervention seem to be exhausted. Consequently, there still remains a need for efforts to develop therapies that target reperfusion injury to obtain additional reduction of infarct size.

Therapeutic hypothermia (32 - 35°C) attenuates reperfusion injury and therefore reduces infarct size in a variety of animal models of acute myocardial infarction (AMI), if provided before reperfusion. In human studies this reduction has not been confirmed so far, probably due to the fact that systemic cooling is slow in reducing temperature and therefore target temperature was not reached in time in a substantial number of patients or not reached at all. Furthermore, systemic cooling has side effects such as severe shivering, volume overload and an enhanced adrenergic state. However, subgroups of patients in all randomized clinical trials with anterior myocardial infarction who reached target temperature before reperfusion did show a reduction in infarct size.

To make therapeutic hypothermia into a valuable treatment for AMI, the method of inducing hypothermia has therefore to be modified. This method should be clinical feasible and quick enough to provide myocardial hypothermia before reperfusion, without prolonging symptom-to-balloon times and without the adverse effects of systemic cooling.

In this study the investigators will evaluate the safety and feasibility of intracoronary hypothermia in 10 patients with acute myocardial infarction.

In study patients, routine primary percutaneous intervention will be commenced. Before reperfusion, saline on room temperature will be infused though the occlusion in the infarct related artery using an over the wire balloon catheter during 10 minutes. The balloon will be inflated to prevent reperfusion in that phase. After 10 minutes the balloon will be deflated allowing reperfusion and infusion with saline on 4°C will be continued for 10 minutes. After this, a coronary stent will be placed. Primary end points are safety and feasibility of this method.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

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

Study Locations

  • Netherlands
    • Noord-Brabant
      • Eindhoven, Noord-Brabant, Netherlands, 5623 EJ
        • Catharina hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients will be eligible for this study when they are admitted for acute ST elevation myocardial infarction with a total ST-segment deviation of more than 5 mm and presenting within 6 hours after onset of complaints.

Patients should have a TIMI 0, 1 or 2 flow in the infarction related artery.

Exclusion Criteria:• Age < 18 year

  • Cardiogenic shock or pre-shock
  • Poor clinical condition with concomitant inconvenience like repeated vomiting, severe chest pain or elsewise according to the judgment of the treating interventionalist.
  • Patients with previous myocardial infarction in the culprit area of with previous bypass surgery
  • Tortuous coronary arteries
  • Complex or long-lasting primary PCI expected
  • Inability to understand and give informed consent either in first instance on the table or in second instance on the coronary care unit.
  • Other known myocardial diseases, such as moderate or severe left ventricular hypertrophy or cardiomyopathy
  • Pregnancy
  • First degree AV-block, Mobitz I and Mobitz II block, trifascicular block, or total AV block, Left- and Right Bundle Branch Block
  • Patients in whom no access to the coronary circulation can be obtained by the femoral artery or in whom femoral access was problematic Severe concomitant disease or conditions with a life expectancy of less than one year

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intracoronary hypothermia group
Patients who will receive intracoronary hypothermia before and during percutaneous coronary intervention
Other: intracoronary infusion with saline on 22 and 4°C

Routine primary percutaneous intervention will be commenced. Patient will be asked to participate in the study.

Before reperfusion, saline on room temperature will be infused though the occlusion in the infarct related artery using an over the wire balloon catheter during 10 minutes. The balloon will be inflated to prevent reperfusion in that phase. After 10 minutes the balloon will be deflated allowing reperfusion and infusion with saline on 4°C will be continued for 10 minutes. After this, a coronary stent will be placed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
arrhythmia or AV-block (1st, 2nd or 3rd degree)
Time Frame: 0 - 20 minutes
- Is there a higher incidence of rhythm- or conductance disturbances compared with the routine PCI procedure for myocardial infarction or is any other unforeseen side effect observed.
0 - 20 minutes
Prolonging of door-to-balloon tome measured in minutes
Time Frame: 30 - 60 minutes
  • Is the protocol easy to perform
  • Is a quick temperature drop achieved (< 5min.) As mentioned earlier, one of the hypotheses for the failure to prove benefit of induced hypothermia in earlier trials, was the relatively long time to achieve the target temperature or the failure to achieve the target temperature at all. Therefore, in this study a quick temperature drop should be recorded in the temperature wire placed distal to the coronary occlusion. A quick temperature drop is defined as a significant drop in distal coronary temperature (<5 °C) within 5 minutes after start of the infusion.
  • After reaching the targeted temperature, is it possible to obtain a stable coronary temperature during 20 minutes.
  • How long is he Door-to-balloon time delayed
30 - 60 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to target temperature in seconds
Time Frame: 0 - 20
Time to target temperature
0 - 20

Collaborators and Investigators

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

Sponsor

Catharina Ziekenhuis Eindhoven

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

June 1, 2016

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

April 4, 2016

First Submitted That Met QC Criteria

April 24, 2016

First Posted (Estimate)

April 28, 2016

Study Record Updates

Last Update Posted (Estimate)

November 22, 2016

Last Update Submitted That Met QC Criteria

November 19, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SINTAMI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

by publishing the results in a peer reviewed journal

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.

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