Skip to main content
OpenTrials
Completed

NCT Number: NCT02312336

A Pilot Study of Transcoronary Myocardial Cooling

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Brompton and Harefield NHS Foundation Trust

Uxbridge, Middlesex, UB9 6JH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cohort A - Room temperature coronary perfusate

Other

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

Other

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.

Primary outcomes

  1. Symptoms of Chest pain and breathlessness using a Visual Analog Scale

    Time frame: Throughout the PPCI Procedure and for One Hour Afterwards

  2. Haemodynamic changes using the blood pressure (mmHg) and heart rate (beats /min)

    Time frame: Throughout the PPCI Procedure and for One Hour Afterwards

  3. ECG changes (ST segment shift in mm)

    Time frame: Throughout the PPCI Procedure and for One Hour Afterwards

  4. Duration and Volume of perfusate infused used (total time-mins and total volume-mls)

    Time frame: Throughout the PPCI Procedure and for One Hour Afterwards

  5. Intracoronary temperature measured with thermistor wire

    Time frame: Throughout the PPCI Procedure only

Secondary outcomes

  1. Biomarker rise (Cardiac troponin)

    Time frame: 24 hours post PCI procedure

  2. Myocardial infarct size measured with MRI Heart Scan

    Time frame: During hospital admission

Sponsors and collaborators

Lead sponsor

Royal Brompton & Harefield NHS Foundation Trust

Other

Registry information

Official study 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.

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 9, 2014
Registry last updated
Jul 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.