Safety and Feasibility of Intracoronary Hypothermia in Acute Myocardial Infarction

NCT02753478 | Completed Phase 1 DMC

• 1 other identifier: SINTAMI
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myocardial Infarction

Keywords

hypothermia

Outcome Measures

Primary Outcomes (2)

• arrhythmia or AV-block (1st, 2nd or 3rd degree)

  \- 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

  * 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 Outcomes (1)

• Time to target temperature in seconds

  0 - 20

Study Arms (1)

intracoronary hypothermia group

EXPERIMENTAL

Patients who will receive intracoronary hypothermia before and during percutaneous coronary intervention

Other: intracoronary infusion with saline on 22 and 4°C

Interventions

intracoronary infusion with saline on 22 and 4°C OTHER

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.

intracoronary hypothermia group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Catharina Ziekenhuis Eindhoven: lead

Study Sites (1)

Catharina Hospital

Eindhoven, North Brabant, 5623 EJ, Netherlands

Location

Related Publications (2)

• Tissier R, Ghaleh B, Cohen MV, Downey JM, Berdeaux A. Myocardial protection with mild hypothermia. Cardiovasc Res. 2012 May 1;94(2):217-25. doi: 10.1093/cvr/cvr315. Epub 2011 Nov 29.

  PMID: 22131353 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Myocardial Infarction; Hypothermia

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Body Temperature Changes; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 4, 2016
• First Posted: April 28, 2016
• Study Start: June 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: November 22, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)