A Pilot Study of Transcoronary Myocardial Cooling

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02312336
Study type	Interventional
Source	Royal Brompton & Harefield NHS Foundation Trust
Contact
Status	Completed
Phase	N/A
Start date	September 2014
Completion date	July 2015

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.