A Pilot Study of Transcoronary Myocardial Cooling

Acute Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02312336
• Other study ID #: 14/LO/0476
• Status: Completed
• Phase: N/A
• First received: September 18, 2014
• Last updated: July 27, 2015
• Start date: September 2014
• Est. completion date: July 2015

Study information

• Verified date: July 2015
• Source: Royal Brompton & Harefield NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Men and women aged between 18 and 80 years presenting with ischaemic chest pain of <6 hours and STsegment elevation on the ECG of >0.2 mV in 2 contiguous leads.

Exclusion Criteria:

• Patients with cardiac arrest, previous AMI or CABG, known congestive heart failure, endstage kidney disease or hepatic failure, recent stroke, coagulopathy, pregnancy, or cardiogenic shock.

• Patients who are unable or unwilling to provide assent and informed consent.

Study Design

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction
• Myocardial Reperfusion Injury

Intervention

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.
• 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.

Locations

Country	Name	City	State
United Kingdom	Royal Brompton and Harefield NHS Foundation Trust	Uxbridge	Middlesex

Sponsors (1)

Lead Sponsor	Collaborator
Royal Brompton & Harefield NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms of Chest pain and breathlessness using a Visual Analog Scale		Throughout the PPCI Procedure and for One Hour Afterwards	Yes
Primary	Haemodynamic changes using the blood pressure (mmHg) and heart rate (beats /min)		Throughout the PPCI Procedure and for One Hour Afterwards	Yes
Primary	ECG changes (ST segment shift in mm)		Throughout the PPCI Procedure and for One Hour Afterwards	Yes
Primary	Duration and Volume of perfusate infused used (total time-mins and total volume-mls)		Throughout the PPCI Procedure and for One Hour Afterwards	Yes
Primary	Intracoronary temperature measured with thermistor wire		Throughout the PPCI Procedure only	Yes
Secondary	Biomarker rise (Cardiac troponin)		24 hours post PCI procedure	Yes
Secondary	Myocardial infarct size measured with MRI Heart Scan		During hospital admission	Yes