An interventional study of Transcoronary cooling and dilution and Standard of care in Myocardial Infarction and Reperfusion Injury, Myocardial, sponsored by Royal Brompton & Harefield NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-31.
Sponsored by Royal Brompton & Harefield NHS Foundation Trust · Not applicable, Interventional, and Treatment
A heart attack (myocardial infarction) occurs when an artery supplying blood to the heart is suddenly blocked resulting in damage to the heart muscle.
Patients presenting to hospital with a heart attack undergo an immediate angiogram (x-ray of the arteries in the heart) and are usually treated immediately with a balloon and stent to open their blocked artery. This procedure is called "primary percutaneous coronary intervention" (or primary PCI for short).
An angiogram is a routine procedure that involves insertion of fine plastic tube (catheter) into either the groin or wrist under local anaesthetic. The tube is passed into the artery in the heart and X-ray pictures are taken to find out if the arteries are blocked. Blocked arteries can usually be opened by passing a small balloon into the artery, via the fine plastic tube followed by placement of a stent (a fine metal coil) into the artery to prevent it from blocking again.
Although this treatment is very successful, it can result in damage to the heart muscle when the artery is opened. 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.
The investigators are conducting a series of research studies to find out if cooling the heart muscle directly through the catheter being used for the normal primary angioplasty treatment using room temperature may be effective in preserving heart muscle, without the shortcomings of entire body cooling.
The investigators have already published an initial series of ten cases in which this treatment appeared to be feasible without causing significant clinical problems.
The present study is a pilot study designed to assess the rate of patient recruitment and feasibility of this new treatment while exploring some detailed outcomes measuring the restoration of blood flow within the coronary artery at the end of the procedure.
Ultimately if the present pilot study is successful, the investigators plan to go on to undertake a much larger randomised outcome study to determine definitively whether this treatment can help reduce heart attack size.
The study population will comprise 60 patients with ST-Elevation Myocardial Infarction (STEMI) presenting to Harefield Hospital undergoing primary percutaneous coronary intervention (PCI).
The primary aim of this pilot trial is to investigate the recruitment rate feasibility and safety of undertaking a randomised trial of simple intracoronary coronary cooling and dilution through the guiding catheter during primary PCI for STEMI to reduce myocardial infarction size.
The secondary aims are as follows:
Patients will be randomised 1:1 in the catheterisation lab when coronary angiography has demonstrated a target lesion with proposed primary PCI. Patients randomised to the intervention will receive transcatheter cooling and dilution in addition to usual clinical care. Patients randomised to control will receive usual care alone.
A combined thermistor and pressure wire Coroventis™ (Abbott Vascular) with comparable tip stiffness to standard guidewires and in routine clinical use, will be used to perform the primary PCI procedure and to measure intracoronary temperature and pressure continually throughout all procedures in all patients. This will therefore limit the procedure to a simple single wire throughout strategy in most cases. In the event that the wire fails to function properly during or after the PCI procedure it may be changed for a new wire using standard interventional techniques as appropriate
Patients randomised to intracoronary cooling and dilution(n=30), will receive an intracoronary infusion of room temperature 0.9% Normal Saline solution through the guiding catheter which will commence immediately prior to crossing the coronary occlusion with the guidewire. Using a 3-way tap in the procedural manifold an infusion pressure of 150mmHg above systolic blood pressure achieved with a pressure bag will be used to achieve a target intracoronary temperature of 6-8 C° below the baseline temperature. The infusion will continue until 10 minutes after the lesion is crossed and distal flow is restored, with only brief interruptions as required for the clinical procedure. A maximum volume of 750ml will be infused. The primary angioplasty procedure itself will be undertaken according to standard local practice. Patients randomised to the control group (n=30) will undergo primary PCI according to standard local practice.
A complete physiological study including Fractional flow reserve (FFR), resting full-cycle ratio (RFR), coronary flow reserve (CFR), resistive reserve ratio (RRR) and index of microvascular resistance (IMR) to assess microcirculation will be measured 10 minutes after reperfusion in all patients.
Patients will go on to have blood taken on the next day for the analysis of a panel of biomarkers and comparison with pre-procedure levels and in addition to have a cardiac MRI scan prior to discharge and at 6 months.
2,779 studies on the registry are indexed under Myocardial Infarction; 417 are open to participants now.
This study's planned enrollment of 60 is below the median of 148 across 1,613 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →Royal Brompton & Harefield NHS Foundation Trust is the lead sponsor of 140 studies on the registry; 20 are open to participants now.
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Exclusion Criteria:
Intervention with transcoronary cooling and dilution
Other: Transcoronary cooling and dilution
Routine clinical care
Other: Standard of care
Transcoronary cooling and dilution
Routine clinical care
Recruitment rate
Patients recruited per month
Time frame: 1 year
Feasibility (Number of studies where all the planned measurements have been collected / total studies)
Number of studies where all the planned measurements have been collected / total studies
Time frame: 1 year
Safety (Adverse events should not be significantly higher in the treatment arm compared to control, nor plausibly caused by the treatment)
Adverse events should not be significantly higher in the treatment arm compared to control, nor plausibly caused by the treatment as assessed by CTCAE v5.0
Time frame: 1 year
Index of microvascular resistance (IMR) 10 mins after completion of percutaneous coronary intervention and study infusion
Distal coronary pressure during hyperaemia x mean transit time (mmHg·s)
Time frame: 1 hour
Fractional flow reserve (FFR) 10 mins after completion of percutaneous coronary intervention and study infusion
Distal coronary pressure/aortic pressure during hyperaemia
Time frame: 1 hour
Coronary flow reserve (CFR) 10 mins after completion of percutaneous coronary intervention and study infusion
Thermodilution-based ratio of hyperaemic coronary flow/basal flow
Time frame: 1 hour
Resistive reserve ratio (RRR) 10 mins after completion of percutaneous coronary intervention and study infusion
Index of microvascular resistance rest/hyperaemia
Time frame: 1 hour
Resting full-cycle ratio (RFR) 10 mins after completion of percutaneous coronary intervention and study infusion
lowest value of distal coronary pressure/aortic pressure over the entire cardiac cycle at rest
Time frame: 1 hour
Intracoronary temperature change
Intracoronary temperature change during cooling and dilution (°C)
Time frame: 1 hour
Infusion volume
Total volume of intracoronary saline infused (ml)
Time frame: 1 hour
Infusion rate
Total volume of intracoronary saline infused/infusion time (ml/min)
Time frame: 1 hour
Chest pain during study infusion
Whether new chest pain arises, or chest pain increases during study infusion
Time frame: 1 hour
ECG changes during study infusion
Amelioration or worsening of the ECG anomalies during study infusion (ST elevation/depression, T wave inversion, QT prolongation)
Time frame: 1 hour
Heart rhythm changes during study infusion
Appearance or resolution of heart rhythm disturbances during study infusion (sinus tachycardia, supraventricular tachycardia, atrial tachycardia/fibrillation/flutter, ventricular tachycardia/flutter, ventricular fibrillation, sinus bradycardia, grade I, II, or III heart block, asystole.
Time frame: 1 hour
Myocardial blush grade 10 mins after completion of percutaneous coronary intervention and study infusion
Angiographic myocardial perfusion measurement based on visual assessment of the myocardium after contrast injection. Grading: 0, no myocardial blush or contrast density; 1, minimal myocardial blush or contrast density; 2, moderate myocardial blush or contrast density but less than that obtained during angiography of a contralateral or ipsilateral non-infarct-related coronary artery; and 3, normal myocardial blush or contrast density, comparable with that obtained during angiography of a contralateral or ipsilateral non-infarct-related coronary artery
Time frame: 1 hour
Thrombolysis in Myocardial Infarction (TIMI) flow 10 mins after completion of percutaneous coronary intervention and study infusion
Visual angiographic assessment of coronary flow. Grade 0 = no perfusion; grade 1 = penetration without perfusion; 2 = partial perfusion; 3 = complete perfusion
Time frame: 1 hour
ST segment resolution 10 mins after completion of percutaneous coronary intervention and study infusion
Null, partial, or complete resolution of the ST elevation
Time frame: 1 hour
Heart Rhythm disturbance from baseline to 12 hours
Appearance or resolution of heart rhythm disturbances in the 12 hours after the procedure (sinus tachycardia, supraventricular tachycardia, atrial tachycardia/fibrillation/flutter, ventricular tachycardia/flutter, ventricular fibrillation, sinus bradycardia, grade I, II, or III heart block, asystole.
Time frame: 12 hours
Haemodynamic compromise from baseline to 12 hours
Society for Cardiovascular Angiography and Interventions (SCAI) class B or above
Time frame: 12 hours
Left ventricular ejection fraction (LVEF) at 48 hours
Simpson biplane (diastolic-systolic)/diastolic left ventricular volume on echocardiography
Time frame: 2 days
Left ventricular ejection fraction (LVEF) at 6 months
Simpson biplane (diastolic-systolic)/diastolic left ventricular volume on echocardiography
Time frame: 6 months
Wall motion score index (WMSI) at 48 hours
The wall motion score index (WMSI) is an echocardiographic parameter that numerically sums the average scores for all left ventricular segments into a single parameter and then dividing by the number of segments. 1 Normal motion; 2 = hypokinesia; 3 = akinesia; 4 = dyskinesia.
Time frame: 48 hours
Wall motion score index (WMSI) at 6 months
The wall motion score index (WMSI) is an echocardiographic parameter that numerically sums the average scores for all left ventricular segments into a single parameter and then dividing by the number of segments. 1 Normal motion; 2 = hypokinesia; 3 = akinesia; 4 = dyskinesia.
Time frame: 6 months
Global longitudinal strain (GLS) at 48 hours
Echocardiographic speckle-tracking imaging that measures the systolic shortening of left ventricular segments as percentage of their diastolic length
Time frame: 48 hours
Global longitudinal strain (GLS) at 6 months
Echocardiographic speckle-tracking imaging that measures the systolic shortening of left ventricular segments as percentage of their diastolic length
Time frame: 6 months
Length of stay
Duration of hospital length of stay
Time frame: 3-5 days
Peak high-sensitivity cardiac troponin T (hs-cTnT, ng/l)
Myocardial injury marker. Highest hs-cTnT measurement during hospital stay
Time frame: 1-3 days
N-terminal pro-brain natriuretic peptide (NT-proBNP, ng/l)
Heart failure marker. Highest NT-proBNP measurement during hospital stay
Time frame: 1-3 days
Interleukin-1b
Biomarker of inflammation during myocardial infarction
Time frame: 1 day
Interleukin-1 receptor antagonist
Biomarker of inflammation during myocardial infarction
Time frame: 1 day
Interleukin-6
Biomarker of inflammation during myocardial infarction
Time frame: 1 day
Interleukin-10
Biomarker of inflammation during myocardial infarction
Time frame: 1 day
First pass microvascular obstruction extent (FP MVO)
Measured in 3 SAX levels to provide an index of %LV FP MVO
Time frame: 1-3 days
First pass microvascular obstruction extent (FP MVO) at 6 months
Measured in 3 SAX levels to provide an index of %LV FP MVO
Time frame: 6 months
Early MVO extent (% of LV) on 1 min post-gadolinium contrast enhanced MRI, adjusted for area at-risk
Cardiac magnetic resonance-based assessment
Time frame: 1-3 days
Early MVO extent (% of LV) on 1 min post-gadolinium contrast enhanced MRI, adjusted for area at-risk, at 6 months
Cardiac magnetic resonance-based assessment
Time frame: 6 months
Late MVO (presence / absence) on LGE
Cardiac magnetic resonance-based assessment
Time frame: 1-3 days
Late MVO (presence / absence) on LGE at 6 months
Cardiac magnetic resonance-based assessment
Time frame: 6 months
Initial infarct size (LGE)
Mass of infarcted myocardium calculated with the full-width at half-maximum method
Time frame: 1-3 days
Infarct size (LGE) at 6 months
Mass of infarcted myocardium calculated with the full-width at half-maximum method
Time frame: 6 months
Initial MSI (area-at-risk minus initial infarct size/area-at-risk)
Percentage of the area at risk (calculated with the Otsu method) that was not infarcted on late gadolinium enhancement (LGE) images using infarct size from the pre-discharge (Acute MSI)
Time frame: 1-3 days
MSI (area-at-risk minus initial infarct size/area-at-risk) at 6 months
Percentage of the area at risk (calculated with the Otsu method) that was not infarcted on late gadolinium enhancement (LGE) images using infarct size from the follow-up (Final MSI) magnetic resonance imaging
Time frame: 6 months
Left ventricular end-diastolic volume index (LVEDVI)
Cardiac magnetic resonance-based assessment
Time frame: 1-3 days
Left ventricular end-diastolic volume index (LVEDVI) at 6 months
Cardiac magnetic resonance-based assessment
Time frame: 6 months
Left ventricular end-systolic volume index (LVESVI)
Cardiac magnetic resonance-based assessment
Time frame: 1-3 days
Left ventricular end-systolic volume index (LVESVI) at 6 months
Cardiac magnetic resonance-based assessment
Time frame: 6 months
Cardiac Magnetic Resonance-based Left ventricular ejection fraction (LVEF)
Cardiac magnetic resonance-based assessment
Time frame: 1-3 days
Cardiac Magnetic Resonance-based Left ventricular ejection fraction (LVEF) at 6 months
Cardiac magnetic resonance-based assessment
Time frame: 6 months
Myocardial haemorrhage (presence/absence)
Cardiac magnetic resonance-based assessment
Time frame: 1-3 days
Myocardial haemorrhage (presence/absence) at 6 months
Cardiac magnetic resonance-based assessment
Time frame: 6 months
Myocardial haemorrhage extent (% of LV)
Cardiac magnetic resonance-based assessment
Time frame: 1-3 days
Myocardial haemorrhage extent (% of LV) at 6 months
Cardiac magnetic resonance-based assessment
Time frame: 6 months
Composite of all-cause mortality and hospitalization for heart failure at 6 weeks
Composite of all-cause mortality and hospitalization for heart failure at 6 weeks
Time frame: 6 weeks
Hospitalization for heart failure at 6 weeks
Hospitalization for heart failure at 6 weeks
Time frame: 6 weeks
Cardiovascular mortality at 6 weeks
Cardiovascular mortality at 6 weeks
Time frame: 6 weeks
All-cause mortality at 6 weeks
All-cause mortality at 6 weeks
Time frame: 6 weeks
Hospitalization for heart failure at 6 months
Hospitalization for heart failure at 6 months
Time frame: 6 months
Cardiovascular mortality at 6 months
Cardiovascular mortality at 6 months
Time frame: 6 months
Composite of all-cause mortality and hospitalization for heart failure at 6 months
Composite of all-cause mortality and hospitalization for heart failure at 6 months
Time frame: 6 months
All-cause mortality at 6 months
All-cause mortality at 6 months
Time frame: 6 months
Composite of all-cause mortality and hospitalization for heart failure at 12 months
Composite of all-cause mortality and hospitalization for heart failure at 12 months
Time frame: 12 months
Hospitalization for heart failure at 12 months
Hospitalization for heart failure at 12 months
Time frame: 12 months
Cardiovascular mortality at 12 months
Cardiovascular mortality at 12 months
Time frame: 12 months
Plan to share: No
Started Nov 2023 (actual). Primary completion is estimated for Jan 2025, 14 months after the start.
Of 402 non-industry interventional studies with no phase under Myocardial Infarction, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 55. This study's planned 14 months is below that.
Counting every sponsor, half of 438 studies reached it within 32 months; a quarter within 15 and three quarters within 55.
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