Myocardial InfarctionSTEMI-CoolNCT06128993
Trans-coronary Cooling and Dilution for Cardioprotection During Revascularisation for ST-elevation Myocardial Infarction
A study testing Transcoronary cooling and dilution in people with Myocardial Infarction and Reperfusion Injury, Myocardial, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Reperfusion Injury, Myocardial
- What is being tested?
- Transcoronary cooling and dilution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2023to Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical ST-elevation myocardial infarction or equivalent (e.g. new onset LBBB)
- <12 Hrs after symptom onset
- Thrombolysis in myocardial infarction (TIMI) 0-1 coronary flow in a target vessel
Who cannot join
- History of severe asthma
- Pregnancy
- Severe concomitant disease or conditions with a life expectancy of less than one year.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Harefield Hospital
Uxbridge, UB9 6JH
About this study
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).
Read more
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.
Read the detailed description
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:
- The study will explore the invasive haemodynamic assessment of coronary flow and microvascular function
- The study will explore blood biomarkers before and after treatment for myocardial infarction
- The study will explore myocardial salvage after treatment for myocardial infarction with magnetic resonance imaging (MRI) and subsequent final infarct size.
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.
- Being tested
- Transcoronary cooling and dilution, Standard of care
- Medical subject headings
- Myocardial Infarction, Myocardial Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcoronary cooling and dilutionOther
Transcoronary cooling and dilution
Standard of careOther
Routine clinical care
| Study group | Role | What they receive |
|---|---|---|
| Transcoronary cooling and dilution | Experimental | Intervention with transcoronary cooling and dilution Receives: Other: Transcoronary cooling and dilution |
| Standard of care | Active comparator | Routine clinical care Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Patients recruited per month
Measured: 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
Measured: 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
Measured: 1 year
Secondary outcomes (60)
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)
Measured: 1 hour
Fractional flow reserve (FFR) 10 mins after completion of percutaneous coronary intervention and study infusion
Distal coronary pressure/aortic pressure during hyperaemia
Measured: 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
Measured: 1 hour
Resistive reserve ratio (RRR) 10 mins after completion of percutaneous coronary intervention and study infusion
Index of microvascular resistance rest/hyperaemia
Measured: 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
Measured: 1 hour
Intracoronary temperature change
Intracoronary temperature change during cooling and dilution (°C)
Measured: 1 hour
Infusion volume
Total volume of intracoronary saline infused (ml)
Measured: 1 hour
Infusion rate
Total volume of intracoronary saline infused/infusion time (ml/min)
Measured: 1 hour
Chest pain during study infusion
Whether new chest pain arises, or chest pain increases during study infusion
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 12 hours
Haemodynamic compromise from baseline to 12 hours
Society for Cardiovascular Angiography and Interventions (SCAI) class B or above
Measured: 12 hours
Left ventricular ejection fraction (LVEF) at 48 hours
Simpson biplane (diastolic-systolic)/diastolic left ventricular volume on echocardiography
Measured: 2 days
Left ventricular ejection fraction (LVEF) at 6 months
Simpson biplane (diastolic-systolic)/diastolic left ventricular volume on echocardiography
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 6 months
Length of stay
Duration of hospital length of stay
Measured: 3-5 days
Peak high-sensitivity cardiac troponin T (hs-cTnT, ng/l)
Myocardial injury marker. Highest hs-cTnT measurement during hospital stay
Measured: 1-3 days
N-terminal pro-brain natriuretic peptide (NT-proBNP, ng/l)
Heart failure marker. Highest NT-proBNP measurement during hospital stay
Measured: 1-3 days
Interleukin-1b
Biomarker of inflammation during myocardial infarction
Measured: 1 day
Interleukin-1 receptor antagonist
Biomarker of inflammation during myocardial infarction
Measured: 1 day
Interleukin-6
Biomarker of inflammation during myocardial infarction
Measured: 1 day
Interleukin-10
Biomarker of inflammation during myocardial infarction
Measured: 1 day
First pass microvascular obstruction extent (FP MVO)
Measured in 3 SAX levels to provide an index of %LV FP MVO
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months
Late MVO (presence / absence) on LGE
Cardiac magnetic resonance-based assessment
Measured: 1-3 days
Late MVO (presence / absence) on LGE at 6 months
Cardiac magnetic resonance-based assessment
Measured: 6 months
Initial infarct size (LGE)
Mass of infarcted myocardium calculated with the full-width at half-maximum method
Measured: 1-3 days
Infarct size (LGE) at 6 months
Mass of infarcted myocardium calculated with the full-width at half-maximum method
Measured: 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)
Measured: 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
Measured: 6 months
Left ventricular end-diastolic volume index (LVEDVI)
Cardiac magnetic resonance-based assessment
Measured: 1-3 days
Left ventricular end-diastolic volume index (LVEDVI) at 6 months
Cardiac magnetic resonance-based assessment
Measured: 6 months
Left ventricular end-systolic volume index (LVESVI)
Cardiac magnetic resonance-based assessment
Measured: 1-3 days
Left ventricular end-systolic volume index (LVESVI) at 6 months
Cardiac magnetic resonance-based assessment
Measured: 6 months
Cardiac Magnetic Resonance-based Left ventricular ejection fraction (LVEF)
Cardiac magnetic resonance-based assessment
Measured: 1-3 days
Cardiac Magnetic Resonance-based Left ventricular ejection fraction (LVEF) at 6 months
Cardiac magnetic resonance-based assessment
Measured: 6 months
Myocardial haemorrhage (presence/absence)
Cardiac magnetic resonance-based assessment
Measured: 1-3 days
Myocardial haemorrhage (presence/absence) at 6 months
Cardiac magnetic resonance-based assessment
Measured: 6 months
Myocardial haemorrhage extent (% of LV)
Cardiac magnetic resonance-based assessment
Measured: 1-3 days
Myocardial haemorrhage extent (% of LV) at 6 months
Cardiac magnetic resonance-based assessment
Measured: 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
Measured: 6 weeks
Hospitalization for heart failure at 6 weeks
Hospitalization for heart failure at 6 weeks
Measured: 6 weeks
Cardiovascular mortality at 6 weeks
Cardiovascular mortality at 6 weeks
Measured: 6 weeks
All-cause mortality at 6 weeks
All-cause mortality at 6 weeks
Measured: 6 weeks
Hospitalization for heart failure at 6 months
Hospitalization for heart failure at 6 months
Measured: 6 months
Cardiovascular mortality at 6 months
Cardiovascular mortality at 6 months
Measured: 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
Measured: 6 months
All-cause mortality at 6 months
All-cause mortality at 6 months
Measured: 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
Measured: 12 months
Hospitalization for heart failure at 12 months
Hospitalization for heart failure at 12 months
Measured: 12 months
Cardiovascular mortality at 12 months
Cardiovascular mortality at 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start1 Nov 2023
- Primary completionJan 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised placebo controlled
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Miles C Dalby, MD, Principal investigator, Royal Brompton & Harefield NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06128993
- Sponsor's protocol ID
- 315559
- Acronym
- STEMI-Cool
- Status last verified
- Nov 2024
- First submitted
- 17 Oct 2023
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Otterspoor LC, Van 't Veer M, Van Nunen LX, Brueren GRG, Tonino PAL, Wijnbergen IF, Helmes H, Zimmermann FM, Van Hagen E, Johnson NP, Pijls NHJ. Safety and feasibility of selective intracoronary hypothermia in acute myocardial infarction. EuroIntervention. 2017 Dec 8;13(12):e1475-e1482. doi: 10.4244/EIJ-D-17-00240.
PubMed 28829744McGarvey M, Ali O, Iqbal MB, Ilsley C, Wong J, Di Mario C, Redwood S, Patterson T, Pennell DJ, Rogers P, Dalby M; ORCA-3 For the Optimal Restoration of Cardiac Activity (ORCA) Group. A feasibility and safety study of intracoronary hemodilution during primary coronary angioplasty in order to reduce reperfusion injury in myocardial infarction. Catheter Cardiovasc Interv. 2018 Feb 1;91(2):234-241. doi: 10.1002/ccd.27136. Epub 2017 Jun 21.
PubMed 28636165Erlinge D, Gotberg M, Lang I, Holzer M, Noc M, Clemmensen P, Jensen U, Metzler B, James S, Botker HE, Omerovic E, Engblom H, Carlsson M, Arheden H, Ostlund O, Wallentin L, Harnek J, Olivecrona GK. Rapid endovascular catheter core cooling combined with cold saline as an adjunct to percutaneous coronary intervention for the treatment of acute myocardial infarction. The CHILL-MI trial: a randomized controlled study of the use of central venous catheter core cooling combined with cold saline as an adjunct to percutaneous coronary intervention for the treatment of acute myocardial infarction. J Am Coll Cardiol. 2014 May 13;63(18):1857-65. doi: 10.1016/j.jacc.2013.12.027. Epub 2014 Feb 5.
PubMed 24509284Carulli E, McGarvey M, Chabok M, Panoulas V, Rosser G, Akhtar M, Smith R, Chandra N, Al-Hussaini A, Kabir T, Barker L, Bruno F, Konstantinou K, de Silva R, Hill J, Xu Y, Lane R, Bucciarelli-Ducci C, Luescher T, Dalby M. Transcoronary cooling and dilution for cardioprotection during revascularisation for ST-segment elevation myocardial infarction: Design and rationale of the STEMI-Cool study. Am Heart J. 2025 Apr;282:40-50. doi: 10.1016/j.ahj.2024.12.009. Epub 2024 Dec 30.
PubMed 39742936
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trans-coronary Cooling and Dilution for Cardioprotection During Revascularisation for ST-elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT06128993
- Acronym / sponsor ID
- STEMI-Cool / 315559
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- The study will explore the invasive haemodynamic assessment of coronary flow and microvascular function
- The study will explore blood biomarkers before and after treatment for myocardial infarction
- The study will explore myocardial salvage after treatment for myocardial infarction with magnetic resonance imaging (MRI) and subsequent final infarct size.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised placebo controlled
| Arm | Type | Receives |
|---|---|---|
| Transcoronary cooling and dilution | Experimental | Other: Transcoronary cooling and dilutionIntervention with transcoronary cooling and dilution |
| Standard of care | Active comparator | Other: Standard of careRoutine clinical care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical ST-elevation myocardial infarction or equivalent (e.g. new onset LBBB)
- <12 Hrs after symptom onset
- Thrombolysis in myocardial infarction (TIMI) 0-1 coronary flow in a target vessel
Key exclusion criteria (3 listed)
- History of severe asthma
- Pregnancy
- Severe concomitant disease or conditions with a life expectancy of less than one year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcoronary cooling and dilutionTranscoronary cooling and dilution | Other | Transcoronary cooling and dilution |
| Standard of careRoutine clinical care | Other | Standard of care |
Primary outcome
Recruitment rate
Time frame: 1 year
Patients recruited per month
Feasibility (Number of studies where all the planned measurements have been collected / total studies)
Time frame: 1 year
Number of studies where all the planned measurements have been collected / total studies
Safety (Adverse events should not be significantly higher in the treatment arm compared to control, nor plausibly caused by the treatment)
Time frame: 1 year
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
60 secondary outcomes
Index of microvascular resistance (IMR) 10 mins after completion of percutaneous coronary intervention and study infusion
Time frame: 1 hour
Fractional flow reserve (FFR) 10 mins after completion of percutaneous coronary intervention and study infusion
Time frame: 1 hour
Coronary flow reserve (CFR) 10 mins after completion of percutaneous coronary intervention and study infusion
Time frame: 1 hour
Resistive reserve ratio (RRR) 10 mins after completion of percutaneous coronary intervention and study infusion
Time frame: 1 hour
Resting full-cycle ratio (RFR) 10 mins after completion of percutaneous coronary intervention and study infusion
Time frame: 1 hour
Intracoronary temperature change
Time frame: 1 hour
Infusion volume
Time frame: 1 hour
Infusion rate
Time frame: 1 hour
Chest pain during study infusion
Time frame: 1 hour
ECG changes during study infusion
Time frame: 1 hour
Heart rhythm changes during study infusion
Time frame: 1 hour
Myocardial blush grade 10 mins after completion of percutaneous coronary intervention and study infusion
Time frame: 1 hour
Thrombolysis in Myocardial Infarction (TIMI) flow 10 mins after completion of percutaneous coronary intervention and study infusion
Time frame: 1 hour
ST segment resolution 10 mins after completion of percutaneous coronary intervention and study infusion
Time frame: 1 hour
Heart Rhythm disturbance from baseline to 12 hours
Time frame: 12 hours
Haemodynamic compromise from baseline to 12 hours
Time frame: 12 hours
Left ventricular ejection fraction (LVEF) at 48 hours
Time frame: 2 days
Left ventricular ejection fraction (LVEF) at 6 months
Time frame: 6 months
Wall motion score index (WMSI) at 48 hours
Time frame: 48 hours
Wall motion score index (WMSI) at 6 months
Time frame: 6 months
Global longitudinal strain (GLS) at 48 hours
Time frame: 48 hours
Global longitudinal strain (GLS) at 6 months
Time frame: 6 months
Length of stay
Time frame: 3-5 days
Peak high-sensitivity cardiac troponin T (hs-cTnT, ng/l)
Time frame: 1-3 days
N-terminal pro-brain natriuretic peptide (NT-proBNP, ng/l)
Time frame: 1-3 days
Interleukin-1b
Time frame: 1 day
Interleukin-1 receptor antagonist
Time frame: 1 day
Interleukin-6
Time frame: 1 day
Interleukin-10
Time frame: 1 day
First pass microvascular obstruction extent (FP MVO)
Time frame: 1-3 days
First pass microvascular obstruction extent (FP MVO) at 6 months
Time frame: 6 months
Early MVO extent (% of LV) on 1 min post-gadolinium contrast enhanced MRI, adjusted for area at-risk
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
Time frame: 6 months
Late MVO (presence / absence) on LGE
Time frame: 1-3 days
Late MVO (presence / absence) on LGE at 6 months
Time frame: 6 months
Initial infarct size (LGE)
Time frame: 1-3 days
Infarct size (LGE) at 6 months
Time frame: 6 months
Initial MSI (area-at-risk minus initial infarct size/area-at-risk)
Time frame: 1-3 days
MSI (area-at-risk minus initial infarct size/area-at-risk) at 6 months
Time frame: 6 months
Left ventricular end-diastolic volume index (LVEDVI)
Time frame: 1-3 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Background: PubMed 28829744Otterspoor LC, Van 't Veer M, Van Nunen LX, Brueren GRG, Tonino PAL, Wijnbergen IF, Helmes H, Zimmermann FM, Van Hagen E, Johnson NP, Pijls NHJ. Safety and feasibility of selective intracoronary hypothermia in acute myocardial infarction. EuroIntervention. 2017 Dec 8;13(12):e1475-e1482. doi: 10.4244/EIJ-D-17-00240.
- Background: PubMed 28636165McGarvey M, Ali O, Iqbal MB, Ilsley C, Wong J, Di Mario C, Redwood S, Patterson T, Pennell DJ, Rogers P, Dalby M; ORCA-3 For the Optimal Restoration of Cardiac Activity (ORCA) Group. A feasibility and safety study of intracoronary hemodilution during primary coronary angioplasty in order to reduce reperfusion injury in myocardial infarction. Catheter Cardiovasc Interv. 2018 Feb 1;91(2):234-241. doi: 10.1002/ccd.27136. Epub 2017 Jun 21.
- Background: PubMed 24509284Erlinge D, Gotberg M, Lang I, Holzer M, Noc M, Clemmensen P, Jensen U, Metzler B, James S, Botker HE, Omerovic E, Engblom H, Carlsson M, Arheden H, Ostlund O, Wallentin L, Harnek J, Olivecrona GK. Rapid endovascular catheter core cooling combined with cold saline as an adjunct to percutaneous coronary intervention for the treatment of acute myocardial infarction. The CHILL-MI trial: a randomized controlled study of the use of central venous catheter core cooling combined with cold saline as an adjunct to percutaneous coronary intervention for the treatment of acute myocardial infarction. J Am Coll Cardiol. 2014 May 13;63(18):1857-65. doi: 10.1016/j.jacc.2013.12.027. Epub 2014 Feb 5.
- Derived from this study: PubMed 39742936Carulli E, McGarvey M, Chabok M, Panoulas V, Rosser G, Akhtar M, Smith R, Chandra N, Al-Hussaini A, Kabir T, Barker L, Bruno F, Konstantinou K, de Silva R, Hill J, Xu Y, Lane R, Bucciarelli-Ducci C, Luescher T, Dalby M. Transcoronary cooling and dilution for cardioprotection during revascularisation for ST-segment elevation myocardial infarction: Design and rationale of the STEMI-Cool study. Am Heart J. 2025 Apr;282:40-50. doi: 10.1016/j.ahj.2024.12.009. Epub 2024 Dec 30.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Miles C Dalby, MD principal investigator
Royal Brompton & Harefield NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcoronary cooling and dilution in people with Myocardial Infarction and Reperfusion Injury, Myocardial, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miles C Dalby, MD (+441895 823737, m.dalby@rbht.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06128993, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.