NCT02312336

A Pilot Study of Transcoronary Myocardial Cooling

A Safety and Feasibility Study of Transcoronary Myocardial Buffering and Cooling During Primary Coronary Angioplasty to Reduce Myocardial Reperfusion Injury in Acute Myocardial Infarction.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Royal Brompton & Harefield NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Patients with heart attacks caused by blocked coronary arteries are usually treated with a technique called primary angioplasty. Although this treatment is very successful it can result in damage to the heart muscle when the artery is opened due to reperfusion injury. Cooling the entire body has been shown to reduce heart muscle damage during heart attacks in some patients but not in others, however it is uncomfortable due to the shivering, expensive and can result in delays in opening the blocked artery. We are investigating a simpler way to cool the heart muscle directly using cooled fluid passed through the catheter without the shortcomings of entire body cooling. This pilot will address safety and feasibility considerations.

Detailed description

The precise mechanisms involved in ischaemia/reperfusion injury is not fully understood but a number of factors are thought to contribute to cardiac dysfunction14, 15. These include : 1. reperfusion arrhythmias; 2. microvascular obstruction or no-reflow phenomenon; 3. myocardial stunning and 4. cardiomyocyte apoptosis. It is estimated that ischaemia/reperfusion injury occurs in \> 30% of patients and is associated with reduced myocardial salvage and poor prognosis16-18. Ischaemia/reperfusion injury may account for up to 50% of the final infarct size9. Deep hypothermia (\< 30 °C) has long been used in protecting the heart during coronary artery bypass grafting and heart transplantation. Intermittent antegrade or retrograde infusion of cold cardioplegia appears to reduce myocardial ischaemia and improves outcome19, 20. Deep hypothermia however can cause spontaneous ventricular fibrillation and impaired cardiac function and its application is limited to the unconscious patient.

Conditions

• Acute Myocardial Infarction

Interventions

Type	Name	Description
OTHER	Cohort A - Room temperature coronary perfusate	Patients recruited into the study will receive standard PPCI and in addition a transcoronary infusion of Hartmans solution at room temperature (Cohort A). The research intervention is the infusion of room temperature Hartmans solution.
OTHER	Cohort B - Cooled coronary perfusate	Patients recruited into the study will receive standard PPCI and in addition a transcoronary infusion of Hartmans solution cooled at 15 degrees (Cohort B). The research intervention is the infusion of Hartmans solution cooled to 15 degrees.

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2014-12-09
• Last updated: 2015-07-28

Locations

1 site across 1 country: United Kingdom