Acute Myocardial InfarctionEURO-ICENCT03447834
EUROpean Intracoronary Cooling Evaluation in Patients With ST-elevation Myocardial Infarction.
A study testing Selective intracoronary hypothermia + PPCI and Standard PPCI in people with Acute Myocardial Infarction and Reperfusion Injury, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
Trial summary
In acute myocardial infarction, early restoration of epicardial and myocardial blood flow is of paramount importance to limit infarction size and create optimum conditions for favourable long-term outcome. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Myocardial Infarction, Reperfusion Injury
- What is being tested?
- Selective intracoronary hypothermia + PPCI and Standard PPCI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2019to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute anterior wall ST-elevation myocardial infarction
- Total ST-segment deviation of at least 5 mm
- Presenting within 6 hours after onset of complaints
- TIMI 0 or 1 flow in the LAD
- Hemodynamically stable and in an acceptable clinical condition
- Able to give informed consent
Who cannot join
- Age <18 year or >80 year
- Cardiogenic shock or hemodynamically unstable patients
- Patients with previous myocardial infarction in the culprit artery of with previous bypass surgery
- Very tortuous or calcified coronary arteries
- Complex or long-lasting primary PCI expected
- Severe concomitant disease or conditions with a life expectancy of less than one year
Show all 10Show fewer
- Inability to understand and give informed consent
- Known contra-indication for MRI
- Pregnancy
- Severe conduction disturbances necessitating implantation of temporary pacemaker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Selective Intracoronary Hypothermia in Patients With ST-elevation Myocardial Infarction to Reduce Infarct Size
In acute myocardial infarction, early restoration of epicardial and myocardial blood flow is of paramount importance to limit infarction size and create optimum conditions for favourable long-term outcome. Currently, restoration of epicardial blood flow is preferably and effectively obtained by primary percutaneous coronary intervention (PPCI). After opening the occluded artery, however, the reperfusion process itself causes damage to the myocardium, the so called "reperfusion injury". The phenomenon of reperfusion injury is incompletely understood and currently there is no established therapy for preventing it. Contributory factors are intramyocardial edema with compression of the microvasculature, oxidative stress, calcium overload, mitochondrial transition pore opening, micro embolization, neutrophil plugging and hyper contracture. This results in myocardial stunning, reperfusion arrhythmias and ongoing myocardial necrosis. There is general agreement that a large part of the cell death caused by myocardial reperfusion injury occurs during the first few minutes of reperfusion, and that early treatment is required to prevent it.
Myocardial hypothermia may attenuate the pathological mechanisms mentioned above. However, limited data are available on the beneficial effects of hypothermia to protect the myocardium from reperfusion damage. In animals, several studies demonstrated a protective effect of hypothermia on the infarction area. This effect was only noted when hypothermia was established before reperfusion. Hypothermia is therefore thought to attenuate several damaging acute reperfusion processes such as oxidative stress, release of cytokines and development of interstitial or cellular edema. Furthermore, it has been shown that induced hypothermia resulted in increased ATP-preservation in the ischemic myocardium compared to normothermia. The intracoronary use of hypothermia by infused cold saline in pigs was demonstrated to be safe by Otake et al. In their study, saline of 4°C was used without complications (such as vasospasm, hemodynamic instability or bradycardia) and it even attenuated ventricular arrhythmia significantly.
Read more
Studies in humans, however, have not been able to confirm this effect, which is believed to be mainly due to the fact that the therapeutic temperature could not reached before reperfusion in the majority of patients or not achieved at all. Furthermore, in these studies it was intended to induce total body hypothermia, which in turn may lead to systemic reactions such as shivering and enhanced adrenergic state often requiring sedatives, which may necessitate artificial ventilation.
In fact, up to now any attempt to achieve therapeutic myocardial hypothermia in humans with myocardial infarction, is fundamentally limited because of four reasons:
- Inability to cool the myocardium timely, i.e. before reperfusion
- Inability to cool the diseased myocardium selectively
- Inability to achieve an adequate decrease of temperature quick enough
- Inability to achieve an adequate decrease of temperature large enough
Consequently, every attempt to achieve effective hypothermia in ST-segment myocardial infarction in humans has been severely hampered and was inadequate. In the last two years, the investigators have developed a methodology overcoming all of the limitations mentioned above. At first, the investigators have tested that methodology in isolated beating pig hearts with coronary artery occlusion and next, the investigators have tested the safety and feasibility of this methodology in humans.
Therefore, the time has come to perform a proof-of-principle study in humans, which is the subject of this protocol.
- Conditions
- Acute Myocardial Infarction, Reperfusion Injury
- Being tested
- Selective intracoronary hypothermia + PPCI, Standard PPCI
- Keywords
- intracoronary cooling
- Medical subject headings
- Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective intracoronary hypothermia + PPCIOther
Also called Selective intracoronary hypothermia
Selective intracoronary hypothermia is a new technique, recently tested for safety and feasibility in the SINTAMI trial. The procedure starts by advancing a guidewire beyond the occlusion in the culprit artery, followed by an OTWB that is inflated at the location of the occlusion, at a low pressure (4 atm), to prevent reperfusion. After that, a pressure/temperature wire will be advanced along the inflated OTWB and is placed in the distal coronary artery. Then the guidewire is removed and the lumen is used for infusion of saline. During the 'occlusion phase', saline at room temperature is infused for 10 minutes with distal coronary temperature 6-8°C below body temperature. After that, the balloon of the OTWB is deflated. Simultaneously, infusion is started with saline of 4°C, the so called 'reperfusion phase'. This is continued for 10 more minutes. After that, the OTWB can be retracted and the procedure can continue not different from routine PPCI.
Standard PPCIOther
PPCI per routine
| Study group | Role | What they receive |
|---|---|---|
| Selective intracoronary hypothermia + PPCI | Experimental | Patients will be eligible for this study if they are admitted for acute anterior wall ST-elevation myocardial infarction with total ST-segment deviation of at least 5 mm. If the patient has TIMI grade flow 0 or 1, the experimental arm will be treated by selective intracoronary hypothermia just before and after reperfusion, in addition to routine PPCI. Receives: Other: Selective intracoronary hypothermia + PPCI |
| Standard PPCI | Other | The control group will receive routine PPCI. Receives: Other: Standard PPCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint- Infarct size
The primary endpoint is the final infarct size (expressed in % of left ventricular mass) on MRI, made 3 months after the infarction revealed by late gadolinium enhancement.
Measured: From date of randomization until the date of the MRI made after 3 months
Secondary outcomes (41)
Secondary endpoint, composite of all-cause mortality and hospitalization for heart failure at 3
Composite of all-cause mortality and hospitalization for heart failure at 3 months
Measured: From date of randomization until 3 months later
Secondary endpoint, composite of all-cause mortality and hospitalization for heart failure at 1 year
Composite of all-cause mortality and hospitalization for heart failure at 1 year
Measured: From date of randomization until 1 year later
Secondary endpoint, all-cause mortality at 3 months
All-cause mortality at 3 months
Measured: From date of randomization until 3 months later
Secondary endpoint, all-cause mortality at 1 year
All-cause mortality at 1 year
Measured: From date of randomization until 1 year later
Secondary endpoint, hospitalization for heart failure at 3 months
Hospitalization for heart failure at 3 months
Measured: From date of randomization until 3 months later
Secondary endpoint, hospitalization for heart failure at 1 year
Hospitalization for heart failure at 1 year
Measured: From date of randomization until 1 year later
Secondary endpoint, cardiac death at 3 months
Cardiac death at 3 months
Measured: From date of randomization until 3 months later
Secondary endpoint, cardiac death at 1 year
Cardiac death at 1 year
Measured: From date of randomization until 1 year later
Secondary endpoint, peak value of high-sensitivity troponin T (hs-TnT)
Peak value of high-sensitivity troponin T (hs-TnT)
Measured: From date of randomization until 1 week later
Secondary endpoint, peak value of creatine kinase (CK)
Peak value of creatine kinase (CK)
Measured: From date of randomization until 1 week later
Secondary endpoint, peak value of creatine kinase-MB mass (CK-MB)
Peak value of creatine kinase-MB mass (CK-MB)
Measured: From date of randomization until 1 week later
Secondary endpoint, echocardiography outcome
Left ventricular ejection fraction measured by echocardiography (biplane Simpson's method) at 3 months
Measured: From date of randomization until 3 months later
Secondary endpoint, echocardiography outcome
Left ventricular ejection fraction measured by echocardiography (biplane Simpson's method) at 1 year
Measured: From date of randomization until 1 year later
Secondary endpoint, echocardiography outcome
Wall motion score index (WMSI) by echocardiography at 3 months
Measured: From date of randomization until 3 months later
Secondary endpoint, echocardiography outcome
Wall motion score index (WMSI) by echocardiography at 1 year
Measured: From date of randomization until 1 year later
Secondary endpoint, MRI outcome at baseline
First pass microvascular obstruction extent (FP MVO); NB first pass will be acquired in 3 SAX levels to provide an index of %LV FP MVO
Measured: From date of randomization until 5-7 days later; baseline MRI
Secondary endpoint, MRI outcome at baseline
Early MVO extent (% of LV) on 1 min post-gadolinium contrast enhanced MRI, adjusted for area at-risk
Measured: From date of randomization until 5-7 days later; baseline MRI
Secondary endpoint, MRI outcome at baseline
Late MVO (presence / absence) on LGE
Measured: From date of randomization until 5-7 days later; baseline MRI
Secondary endpoint, MRI outcome at baseline
Initial infarct size (LGE)
Measured: From date of randomization until 5-7 days later; baseline MRI
Secondary endpoint, MRI outcome at baseline
Initial MSI (area-at-risk minus initial infarct size/area-at-risk)
Measured: From date of randomization until 5-7 days later; baseline MRI
Secondary endpoint, MRI outcome at baseline
Left ventricular end-diastolic volume index (LVEDVI)
Measured: From date of randomization until 5-7 days later; baseline MRI
Secondary endpoint, MRI efficacy at baseline
Left ventricular end-systolic volume index (LVESVI)
Measured: From date of randomization until 5-7 days later; baseline MRI
Secondary endpoint, MRI outcome at baseline
Left ventricular global longitudinal strain
Measured: From date of randomization until 5-7 days later; baseline MRI
Secondary endpoint, MRI outcome at baseline
Left ventricular circumferential strain (mid-LV)
Measured: From date of randomization until 5-7 days later; baseline MRI
Secondary endpoint, MRI outcome at baseline
Left ventricular ejection fraction (LVEF)
Measured: From date of randomization until 5-7 days later; baseline MRI
Secondary endpoint, MRI outcome at baseline
Systolic wall thickening in the culprit artery territory
Measured: From date of randomization until 5-7 days later; baseline MRI
Secondary endpoint, MRI outcome at baseline
Wall motion score index (WMSI)
Measured: From date of randomization until 5-7 days later; baseline MRI
Secondary endpoint, MRI outcome at baseline
Myocardial haemorrhage (presence/absence)
Measured: From date of randomization until 5-7 days later; baseline MRI
Secondary endpoint, MRI outcome at baseline
Myocardial haemorrhage extent (% of LV)
Measured: From date of randomization until 5-7 days later; baseline MRI
Secondary endpoint, MRI outcome at follow-up
Final myocardial salvage index (area-at-risk minus final infarct size/area-at-risk)
Measured: From date of randomization until 3 months later; follow-up MRI
Secondary endpoint, MRI outcome at follow-up
Change in infarct size 3 months after procedure (LGE at baseline minus LGE at 3 months)
Measured: From date of randomization until 3 months later; follow-up MRI
Secondary endpoint, MRI outcome at follow-up
Final left ventricular end-diastolic volume index (LVEDVI)
Measured: From date of randomization until 3 months later; follow-up MRI
Secondary endpoint, MRI outcome at follow-up
Final left ventricular end-systolic volume index (LVESVI)
Measured: From date of randomization until 3 months later; follow-up MRI
Secondary endpoint, MRI outcome at follow-up
Final left ventricular ejection fraction (LVEF)
Measured: From date of randomization until 3 months later; follow-up MRI
Secondary endpoint, MRI outcome at follow-up
Final left ventricular global longitudinal strain
Measured: From date of randomization until 3 months later; follow-up MRI
Secondary endpoint, MRI outcome at follow-up
Final left ventricular circumferential strain (mid-LV)
Measured: From date of randomization until 3 months later; follow-up MRI
Secondary endpoint, MRI outcome, difference between baseline and follow-up
Change from baseline left ventricular end-diastolic volume index (LVEDVI)
Measured: From date of randomization until 3 months later; follow-up MRI
Secondary endpoint, MRI outcome, difference between baseline and follow-up
Change from baseline left ventricular end-systolic volume index (LVESVI)
Measured: From date of randomization until 3 months later; follow-up MRI
Secondary endpoint, MRI outcome, difference between baseline and follow-up
Change from baseline left ventricular ejection fraction (LVEF)
Measured: From date of randomization until 3 months later; follow-up MRI
Secondary endpoint, MRI outcome, difference between baseline and follow-up
Change in left ventricular global longitudinal strain
Measured: From date of randomization until 3 months later; follow-up MRI
Secondary endpoint, MRI outcome, difference between baseline and follow-up
Change in left ventricular circumferential strain (mid-LV)
Measured: From date of randomization until 3 months later; follow-up MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start1 Jan 2019
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute 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
- Patients will be randomized in a 1:1 fashion to either routine PPCI (control arm) or intracoronary hypothermia in addition to PPCI (hypothermia arm). For the patients randomized to intracoronary hypothermia will follow the steps below. For the routine PPCI a regular guidewire will be advanced across the occlusion followed by pre-dilatation and/or (direct) stenting according to the operator's preference.
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott, Golden Jubilee National Hospital, Onze Lieve Vrouwziekenhuis Aalst, Copenhagen University Hospital, Rigshospitalet, Örebro University, Sweden, Skane University Hospital, University of Belgrade, Mid and South Essex NHS Foundation Trust
- Responsible party
- Principal investigator, Nico Pijls, Catharina Ziekenhuis Eindhoven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03447834
- Sponsor's protocol ID
- EURO-ICE
- Acronym
- EURO-ICE
- Status last verified
- Jul 2022
- First submitted
- 2 Feb 2018
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
El Farissi M, Pijls NHJ, Good R, Engstrom T, Keeble TR, Beleslin B, De Bruyne B, Frobert O, Erlinge D, Teeuwen K, Eerdekens R, Demandt JPA, Mangion K, Lonborg J, Setz-Pels W, Karamasis G, Wijnbergen I, Vlaar PJ, de Vos A, Brueren GR, Oldroyd K, Berry C, Tonino PAL, Van't Veer M, Otterspoor LC. A randomised trial of selective intracoronary hypothermia during primary PCI. EuroIntervention. 2024 Jun 17;20(12):e740-e749. doi: 10.4244/EIJ-D-23-01042.
PubMed 38887884El Farissi M, Good R, Engstrom T, Oldroyd KG, Karamasis GV, Vlaar PJ, Lonborg JT, Teeuwen K, Keeble TR, Mangion K, De Bruyne B, Frobert O, De Vos A, Zwart B, Snijder RJR, Brueren GRG, Palmers PJ, Wijnbergen IF, Berry C, Tonino PAL, Otterspoor LC, Pijls NHJ. Safety of Selective Intracoronary Hypothermia During Primary Percutaneous Coronary Intervention in Patients With Anterior STEMI. JACC Cardiovasc Interv. 2021 Sep 27;14(18):2047-2055. doi: 10.1016/j.jcin.2021.06.009. Epub 2021 Aug 25.
PubMed 34454860
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Intracoronary Hypothermia in Patients With ST-elevation Myocardial Infarction to Reduce Infarct Size
- ClinicalTrials.gov ID
- NCT03447834
- Acronym / sponsor ID
- EURO-ICE / EURO-ICE
- Conditions
- Acute Myocardial Infarction, Reperfusion Injury
- Keywords
- intracoronary cooling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Collaborators
- Abbott, Golden Jubilee National Hospital, Onze Lieve Vrouwziekenhuis Aalst, Copenhagen University Hospital, Rigshospitalet, Örebro University, Sweden, Skane University Hospital, University of Belgrade, Mid and South Essex NHS Foundation Trust
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 27 Feb 2018 (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.
In acute myocardial infarction, early restoration of epicardial and myocardial blood flow is of paramount importance to limit infarction size and create optimum conditions for favourable long-term outcome. Currently, restoration of epicardial blood flow is preferably and effectively obtained by primary percutaneous coronary intervention (PPCI). After opening the occluded artery, however, the reperfusion process itself causes damage to the myocardium, the so called "reperfusion injury". The phenomenon of reperfusion injury is incompletely understood and currently there is no established therapy for preventing it. Contributory factors are intramyocardial edema with compression of the microvasculature, oxidative stress, calcium overload, mitochondrial transition pore opening, micro embolization, neutrophil plugging and hyper contracture. This results in myocardial stunning, reperfusion arrhythmias and ongoing myocardial necrosis. There is general agreement that a large part of the cell death caused by myocardial reperfusion injury occurs during the first few minutes of reperfusion, and that early treatment is required to prevent it.
Myocardial hypothermia may attenuate the pathological mechanisms mentioned above. However, limited data are available on the beneficial effects of hypothermia to protect the myocardium from reperfusion damage. In animals, several studies demonstrated a protective effect of hypothermia on the infarction area. This effect was only noted when hypothermia was established before reperfusion. Hypothermia is therefore thought to attenuate several damaging acute reperfusion processes such as oxidative stress, release of cytokines and development of interstitial or cellular edema. Furthermore, it has been shown that induced hypothermia resulted in increased ATP-preservation in the ischemic myocardium compared to normothermia. The intracoronary use of hypothermia by infused cold saline in pigs was demonstrated to be safe by Otake et al. In their study, saline of 4°C was used without complications (such as vasospasm, hemodynamic instability or bradycardia) and it even attenuated ventricular arrhythmia significantly.
Studies in humans, however, have not been able to confirm this effect, which is believed to be mainly due to the fact that the therapeutic temperature could not reached before reperfusion in the majority of patients or not achieved at all. Furthermore, in these studies it was intended to induce total body hypothermia, which in turn may lead to systemic reactions such as shivering and enhanced adrenergic state often requiring sedatives, which may necessitate artificial ventilation.
In fact, up to now any attempt to achieve therapeutic myocardial hypothermia in humans with myocardial infarction, is fundamentally limited because of four reasons:
- Inability to cool the myocardium timely, i.e. before reperfusion
- Inability to cool the diseased myocardium selectively
- Inability to achieve an adequate decrease of temperature quick enough
- Inability to achieve an adequate decrease of temperature large enough
Consequently, every attempt to achieve effective hypothermia in ST-segment myocardial infarction in humans has been severely hampered and was inadequate. In the last two years, the investigators have developed a methodology overcoming all of the limitations mentioned above. At first, the investigators have tested that methodology in isolated beating pig hearts with coronary artery occlusion and next, the investigators have tested the safety and feasibility of this methodology in humans.
Therefore, the time has come to perform a proof-of-principle study in humans, which is the subject of this protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized in a 1:1 fashion to either routine PPCI (control arm) or intracoronary hypothermia in addition to PPCI (hypothermia arm). For the patients randomized to intracoronary hypothermia will follow the steps below. For the routine PPCI a regular guidewire will be advanced across the occlusion followed by pre-dilatation and/or (direct) stenting according to the operator's preference.
| Arm | Type | Receives |
|---|---|---|
| Selective intracoronary hypothermia + PPCI | Experimental | Other: Selective intracoronary hypothermia + PPCIPatients will be eligible for this study if they are admitted for acute anterior wall ST-elevation myocardial infarction with total ST-segment deviation of at least 5 mm. If the patient has TIMI grade flow 0 or 1, the experimental arm will be treated by selective intracoronary hypothermia just before and after reperfusion, in addition to routine PPCI. |
| Standard PPCI | Other | Other: Standard PPCIThe control group will receive routine PPCI. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Acute anterior wall ST-elevation myocardial infarction
- Total ST-segment deviation of at least 5 mm
- Presenting within 6 hours after onset of complaints
- TIMI 0 or 1 flow in the LAD
- Hemodynamically stable and in an acceptable clinical condition
Key exclusion criteria (10 listed)
- Age <18 year or >80 year
- Cardiogenic shock or hemodynamically unstable patients
- Patients with previous myocardial infarction in the culprit artery of with previous bypass surgery
- Very tortuous or calcified coronary arteries
- Complex or long-lasting primary PCI expected
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 |
|---|---|---|
| Selective intracoronary hypothermia + PPCIAlso: Selective intracoronary hypothermiaSelective intracoronary hypothermia is a new technique, recently tested for safety and feasibility in the SINTAMI trial. The procedure starts by advancing a guidewire beyond the occlusion in the culprit artery, followed by an OTWB that is inflated at the location of the occlusion, at a low pressure (4 atm), to prevent reperfusion. After that, a pressure/temperature wire will be advanced along the inflated OTWB and is placed in the distal coronary artery. Then the guidewire is removed and the lumen is used for infusion of saline. During the 'occlusion phase', saline at room temperature is infused for 10 minutes with distal coronary temperature 6-8°C below body temperature. After that, the balloon of the OTWB is deflated. Simultaneously, infusion is started with saline of 4°C, the so called 'reperfusion phase'. This is continued for 10 more minutes. After that, the OTWB can be retracted and the procedure can continue not different from routine PPCI. | Other | Selective intracoronary hypothermia + PPCI |
| Standard PPCIPPCI per routine | Other | Standard PPCI |
Primary outcome
Primary endpoint- Infarct size
Time frame: From date of randomization until the date of the MRI made after 3 months
The primary endpoint is the final infarct size (expressed in % of left ventricular mass) on MRI, made 3 months after the infarction revealed by late gadolinium enhancement.
41 secondary outcomes
Secondary endpoint, composite of all-cause mortality and hospitalization for heart failure at 3
Time frame: From date of randomization until 3 months later
Secondary endpoint, composite of all-cause mortality and hospitalization for heart failure at 1 year
Time frame: From date of randomization until 1 year later
Secondary endpoint, all-cause mortality at 3 months
Time frame: From date of randomization until 3 months later
Secondary endpoint, all-cause mortality at 1 year
Time frame: From date of randomization until 1 year later
Secondary endpoint, hospitalization for heart failure at 3 months
Time frame: From date of randomization until 3 months later
Secondary endpoint, hospitalization for heart failure at 1 year
Time frame: From date of randomization until 1 year later
Secondary endpoint, cardiac death at 3 months
Time frame: From date of randomization until 3 months later
Secondary endpoint, cardiac death at 1 year
Time frame: From date of randomization until 1 year later
Secondary endpoint, peak value of high-sensitivity troponin T (hs-TnT)
Time frame: From date of randomization until 1 week later
Secondary endpoint, peak value of creatine kinase (CK)
Time frame: From date of randomization until 1 week later
Secondary endpoint, peak value of creatine kinase-MB mass (CK-MB)
Time frame: From date of randomization until 1 week later
Secondary endpoint, echocardiography outcome
Time frame: From date of randomization until 3 months later
Secondary endpoint, echocardiography outcome
Time frame: From date of randomization until 1 year later
Secondary endpoint, echocardiography outcome
Time frame: From date of randomization until 3 months later
Secondary endpoint, echocardiography outcome
Time frame: From date of randomization until 1 year later
Secondary endpoint, MRI outcome at baseline
Time frame: From date of randomization until 5-7 days later; baseline MRI
Secondary endpoint, MRI outcome at baseline
Time frame: From date of randomization until 5-7 days later; baseline MRI
Secondary endpoint, MRI outcome at baseline
Time frame: From date of randomization until 5-7 days later; baseline MRI
Secondary endpoint, MRI outcome at baseline
Time frame: From date of randomization until 5-7 days later; baseline MRI
Secondary endpoint, MRI outcome at baseline
Time frame: From date of randomization until 5-7 days later; baseline MRI
Secondary endpoint, MRI outcome at baseline
Time frame: From date of randomization until 5-7 days later; baseline MRI
Secondary endpoint, MRI efficacy at baseline
Time frame: From date of randomization until 5-7 days later; baseline MRI
Secondary endpoint, MRI outcome at baseline
Time frame: From date of randomization until 5-7 days later; baseline MRI
Secondary endpoint, MRI outcome at baseline
Time frame: From date of randomization until 5-7 days later; baseline MRI
Secondary endpoint, MRI outcome at baseline
Time frame: From date of randomization until 5-7 days later; baseline MRI
Secondary endpoint, MRI outcome at baseline
Time frame: From date of randomization until 5-7 days later; baseline MRI
Secondary endpoint, MRI outcome at baseline
Time frame: From date of randomization until 5-7 days later; baseline MRI
Secondary endpoint, MRI outcome at baseline
Time frame: From date of randomization until 5-7 days later; baseline MRI
Secondary endpoint, MRI outcome at baseline
Time frame: From date of randomization until 5-7 days later; baseline MRI
Secondary endpoint, MRI outcome at follow-up
Time frame: From date of randomization until 3 months later; follow-up MRI
Secondary endpoint, MRI outcome at follow-up
Time frame: From date of randomization until 3 months later; follow-up MRI
Secondary endpoint, MRI outcome at follow-up
Time frame: From date of randomization until 3 months later; follow-up MRI
Secondary endpoint, MRI outcome at follow-up
Time frame: From date of randomization until 3 months later; follow-up MRI
Secondary endpoint, MRI outcome at follow-up
Time frame: From date of randomization until 3 months later; follow-up MRI
Secondary endpoint, MRI outcome at follow-up
Time frame: From date of randomization until 3 months later; follow-up MRI
Secondary endpoint, MRI outcome at follow-up
Time frame: From date of randomization until 3 months later; follow-up MRI
Secondary endpoint, MRI outcome, difference between baseline and follow-up
Time frame: From date of randomization until 3 months later; follow-up MRI
Secondary endpoint, MRI outcome, difference between baseline and follow-up
Time frame: From date of randomization until 3 months later; follow-up MRI
Secondary endpoint, MRI outcome, difference between baseline and follow-up
Time frame: From date of randomization until 3 months later; follow-up MRI
Secondary endpoint, MRI outcome, difference between baseline and follow-up
Time frame: From date of randomization until 3 months later; follow-up MRI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
- Derived from this study: PubMed 38887884El Farissi M, Pijls NHJ, Good R, Engstrom T, Keeble TR, Beleslin B, De Bruyne B, Frobert O, Erlinge D, Teeuwen K, Eerdekens R, Demandt JPA, Mangion K, Lonborg J, Setz-Pels W, Karamasis G, Wijnbergen I, Vlaar PJ, de Vos A, Brueren GR, Oldroyd K, Berry C, Tonino PAL, Van't Veer M, Otterspoor LC. A randomised trial of selective intracoronary hypothermia during primary PCI. EuroIntervention. 2024 Jun 17;20(12):e740-e749. doi: 10.4244/EIJ-D-23-01042.
- Derived from this study: PubMed 34454860El Farissi M, Good R, Engstrom T, Oldroyd KG, Karamasis GV, Vlaar PJ, Lonborg JT, Teeuwen K, Keeble TR, Mangion K, De Bruyne B, Frobert O, De Vos A, Zwart B, Snijder RJR, Brueren GRG, Palmers PJ, Wijnbergen IF, Berry C, Tonino PAL, Otterspoor LC, Pijls NHJ. Safety of Selective Intracoronary Hypothermia During Primary Percutaneous Coronary Intervention in Patients With Anterior STEMI. JACC Cardiovasc Interv. 2021 Sep 27;14(18):2047-2055. doi: 10.1016/j.jcin.2021.06.009. Epub 2021 Aug 25.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selective intracoronary hypothermia + PPCI and Standard PPCI in people with Acute Myocardial Infarction and Reperfusion Injury, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
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 6 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 6 Jul 2022. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint- Infarct size (time frame: From date of randomization until the date of the MRI made after 3 months). 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 NCT03447834, which also lists 2 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 6 Jul 2022.