Clinical Trial: Efficacy of Endovascular Catheter Cooling Combined With Cold Saline for the Treatment of Acute Myocardial Infarction

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional




Official Title: Rapid Endovascular Catheter Core Cooling Combined With Cold Saline as an Adjunct to Percutaneous Coronary Intervention For the Treatment of Acute Myocardial Infarction

Brief Summary: The purpose of this study is to determine whether treatment of patients suffering from ST-elevation myocardial infarction (STEMI) with 1-2 liters of cold saline and central venous catheter cooling with Philips InnerCool RTx Endovascular System prior to percutaneous coronary intervention (PCI) result in a reduction in infarct size.

Detailed Summary:

Acute myocardial infarction (AMI) is the leading cause of mortality in the western world today. Although reperfusion of the ischemic myocardium is a prerequisite for myocardial salvage, it has been described that the reperfusion in itself may cause additional damage to the myocardium (reperfusion injury). In the safety & feasibility trial RAPID MI-ICE we demonstrated that treatment of patients suffering from STEMI with 1-2 liters of cold saline and central venous catheter cooling with Philips InnerCool RTx Endovascular System prior to PCI was feasible, safe and resulted in a 38% reduction in infarct size/myocardium at risk. The aim of the present study is to confirm this finding in a larger multicenter trial.

The study is a randomized, controlled, evaluator blinded, multicenter trial enrolling 120 patients at ten sites.


Sponsor: Region Skane




Current Primary Outcome: Myocardial infarct size (as a percentage of myocardium at risk) assessed by cardiac MRI. [ Time Frame: At 4±2 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Myocardial infarct size (as a percentage of myocardium at risk) both assessed by cardiac MRI at 4±2 days in the patients who are cooled and achieve a target temperature of < 35 C prior to PCI. [ Time Frame: At 4±2 days ]
  • Myocardial infarct size (as a percentage of myocardium at risk) both assessed by cardiac MRI at 4±2 days in patients with an occluded and non-occluded IRA before PCI. [ Time Frame: At 4±2 days ]
  • Myocardial infarct size (as a percentage of myocardium at risk) both assessed by cardiac MRI at 4±2 days in the per protocol population who are cooled according to protocol and meet inclusion criteria. [ Time Frame: At 4±2 days ]
  • Myocardial infarct size (as a percentage of myocardium at risk) both assessed by cardiac MRI at 4±2 days in patients with anterior or inferior myocardial infarctions separately. [ Time Frame: At 4±2 days ]
  • The effect of the hypothermia protocol on the incidence of death. [ Time Frame: 45±15 days and 6 months. ]
  • Plasma level of high sensitivity Troponin T AUC through 48 hours and peak plasma level of high sensitivity Troponin T within 48 hours after AMI. [ Time Frame: 48 hours ]
  • ST-segment resolution 1.5 hour after opening the IRA. [ Time Frame: 1.5 hours ]
  • Coronary blood flow and coronary angiography at the index event estimated by TIMI coronary flow and coronary perfusion grading. [ Time Frame: 2 hours ]
  • Plasma NT-proBNP levels at day 4±2. [ Time Frame: Day 4±2. ]
  • Incidence of death at 1, 2, 3, 4 and 5 years. [ Time Frame: 5 years ]
  • Myocardial infarct size (as a percentage of myocardium at risk) assessed by cardiac MRI at 6±1 months. [ Time Frame: 6 months ]
  • Incidence of heart failure within 45±15 days. [ Time Frame: 6 months ]
  • Incidence of pulmonary oedema. [ Time Frame: 1 week ]
  • Incidence of infections [ Time Frame: 1 week ]
  • Incidence of bleedings [ Time Frame: 1 week ]
  • The effect of the hypothermia protocol on the incidence of recurrent MI. [ Time Frame: 6 months ]
  • The effect of the hypothermia protocol on the incidence of emergent stent revascularisation. [ Time Frame: 6 months ]
  • The effect of the hypothermia protocol on the incidence of any hospitalisation. [ Time Frame: 6 months ]


Original Secondary Outcome:

  • Myocardial infarct size (as a percentage of myocardium at risk) both assessed by cardiac MRI at 4±2 days in the patients who are cooled and achieve a target temperature of < 35 C prior to PCI. [ Time Frame: At 4±2 days ]
  • Myocardial infarct size (as a percentage of myocardium at risk) both assessed by cardiac MRI at 4±2 days in patients with an occluded and non-occluded IRA before PCI. [ Time Frame: At 4±2 days ]
  • Myocardial infarct size (as a percentage of myocardium at risk) both assessed by cardiac MRI at 4±2 days in the per protocol population who are cooled according to protocol and meet inclusion criteria. [ Time Frame: At 4±2 days ]
  • Myocardial infarct size (as a percentage of myocardium at risk) both assessed by cardiac MRI at 4±2 days in patients with anterior or inferior myocardial infarctions separately. [ Time Frame: At 4±2 days ]
  • The effect of the hypothermia protocol on the incidence of the composite of death, heart failure, recurrent MI, emergent stent revascularisation or any hospitalisation at 45±15 days and 6 months. [ Time Frame: At 4±2 days ]
  • Plasma level of high sensitivity Troponin T AUC through 48 hours and peak plasma level of high sensitivity Troponin T within 48 hours after AMI. [ Time Frame: 48 hours ]
  • ST-segment resolution 1.5 hour after opening the IRA. [ Time Frame: 1.5 hours ]
  • Coronary blood flow and coronary angiography at the index event estimated by TIMI coronary flow and coronary perfusion grading. [ Time Frame: 2 hours ]
  • Plasma NT-proBNP levels at day 4±2. [ Time Frame: Day 4±2. ]
  • Incidence of death at 1, 2, 3, 4 and 5 years. [ Time Frame: 5 years ]
  • Myocardial infarct size (as a percentage of myocardium at risk) assessed by cardiac MRI at 6±1 months. [ Time Frame: 6 months ]
  • Incidence of heart failure, pulmonary oedema, infections and bleeding (TIMI definition) within 45±15 days. [ Time Frame: 45±15 days ]


Information By: Region Skane




Dates:
Date Received: June 21, 2011
Date Started: June 2011
Date Completion:
Last Updated: November 5, 2014
Last Verified: November 2014