A Pilot Study of Transcoronary Myocardial Cooling

NCT02312336 | Completed

• 1 other identifier: 14/LO/0476
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Myocardial Infarction

Keywords

ST Elevation Myocardial Infarction; Transcoronary Cooling

Outcome Measures

Primary Outcomes (5)

• Symptoms of Chest pain and breathlessness using a Visual Analog Scale

  Throughout the PPCI Procedure and for One Hour Afterwards

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

  Throughout the PPCI Procedure and for One Hour Afterwards

• ECG changes (ST segment shift in mm)

  Throughout the PPCI Procedure and for One Hour Afterwards

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

  Throughout the PPCI Procedure and for One Hour Afterwards

• Intracoronary temperature measured with thermistor wire

  Throughout the PPCI Procedure only

Secondary Outcomes (2)

• Biomarker rise (Cardiac troponin)

  24 hours post PCI procedure

• Myocardial infarct size measured with MRI Heart Scan

  During hospital admission

Study Arms (2)

Cohort A

PLACEBO COMPARATOR

Cohort A - Room temperature coronary perfusate

Other: Cohort A - Room temperature coronary perfusate

Cohort B

ACTIVE COMPARATOR

Cohort B - Cooled coronary perfusate

Other: Cohort B - Cooled coronary perfusate

Interventions

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 A

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.

Cohort B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead

Study Sites (1)

Royal Brompton and Harefield NHS Foundation Trust

Uxbridge, Middlesex, UB9 6JH, United Kingdom

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

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

Study Officials

• Miles Dalby, MRCP, MD

  Royal Brompton & Harefield NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2014
• First Posted: December 9, 2014
• Study Start: September 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: July 28, 2015

Record last verified: 2015-07

Locations

GB (1)