Myocardial InfarctionPhase 2/3CHILL-MINCT01379261

Efficacy of Endovascular Catheter Cooling Combined With Cold Saline for the Treatment of Acute Myocardial Infarction

A Phase 2/3 study testing Cooling in people with Myocardial Infarction and Myocardial Reperfusion Injury, run by Region Skane at 10 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to determine whether treatment of patients suffering from ST-elevation myocardial infarction (STEMI) with 1-2 liters of cold saline and central venous catheter cooling with Philips InnerCool RTx Endovascular System prior to percutaneous coronary intervention (PCI) result in a reduction in… Read more about this study

Who is it for?: Ages 18 to 79 years
Conditions the study is for: Myocardial Infarction, Myocardial Reperfusion Injury, Anterior Wall Myocardial Infarction
What is being tested?: Cooling
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 10 sitesin 4 countries
Study dates: Jun 2011to Nov 2013
Phase: Phase 2/3
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 79 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Clinical symptoms and signs of myocardial infarction and have a 12-lead ECG providing evidence of an ongoing acute myocardial infarction, involving a large area of myocardium, as defined by the following ECG criteria. The ECG changes should be present upon arrival to the cath lab:
Anterior infarct: ST-segment elevation >0.2mV measured 0.08 sec after the J point in 2 or more anatomically contiguous precordial leads, V1 through V4; and/or >0.2mV in lead V5 V6.
Inferior infarct: ST elevation >0.2mV measured 0.08 sec after the J point in 2 or more anatomically contiguous inferior leads, coupled with ST depression in 2 contiguous anterior leads for a total ST deviation (inferior ST elevation plus anterior ST depression) of >0.8mV.
Present to the study PCI lab within six (6) hours of the onset of acute cardiac ischemic signs or symptoms (such as chest pain or pressure, arm or jaw pain, dyspnea, nausea/vomiting, or syncope).
Be a candidate for PCI and have PCI planned as the immediate intervention.
Be willing and able to comply with study procedures, including returning for the MRI scan at 4 ±2 days and be available for additional follow up Subject understands study procedures and agrees to participate in the study by giving written informed consent.
Be in Killips Class I.

Who cannot join

Age less than eighteen (<18) years of age
Age greater than or equal to eighty (80) years of age
Are pregnant.
Having an aortic dissection
History of a prior large myocardial infarct or an infarct in the same segment that is currently affected.
Acute administration of a thrombolytic agent for the qualifying MI

Show all 22Show fewer

Clinical suspicion of a non-thrombotic (e.g., pericarditis, vasospasm, takotsubo, illicit drug use) cause for ST-segment elevation as determined by the investigator
If (during the screening process) the determination is made by site-study personnel that initiation of cooling prior to diagnostic coronary angiography is technically not feasible for any reason (should the patient be randomized to the Hypothermia Arm), the prospective subject should not be enrolled.
Known risk for heparin induced thrombocytopenia (HIT)
Require an immediate surgical or procedural intervention other than PCI (e.g. CABG)
Present in cardiogenic shock or with end-stage cardiomyopathy
Have undergone at least ten (10) minutes of cardiopulmonary resuscitation (CPR) prior to presentation to the PCI facility
History of surgical coronary artery revascularization (e.g. CABG)
Active bleeding, coagulopathy, or other contraindication to the placement of a heparin-coated 14F central venous catheter via a 14F femoral venous introducer sheath (e.g., known history of heparin induced thrombocytopenia, or IVC filter)
Contraindications to hypothermia
Personal or familial history of malignant hyperthermia
Known end-stage renal disease (ESRD; e.g., on dialysis, or status-post renal transplant), known severe hepatic failure (e.g., cirrhosis, or acute hepatitis), or any other contraindication to receiving meperidine (such as use of MAO inhibitors within previous 14 days, history of seizures, history of hypersensitivity to meperidine, etc.).
Serious concurrant medical condition likely to result in death during the next 12 months. Any other acute or chronic condition which the Investigator believes will unacceptably increase the risk of study participation or interfere with study procedures and assessments.
Contraindication to MRI (e.g., cardiac pacemaker, ICD, nerve stimulator, brain aneurysm clips, cochlear implants, claustrophobia)
Deemed unsuitable by the investigators to participate in the study.
Active or recent (within 1 month prior to study enrollment) participation in another investigational clinical research study.
Enrollment in or planned to be enrolled in another study of AMI therapy

Trial locations and contacts

10 sites in 4 countries.

Country

City, postcode or hospital

10 sites in 4 countries

Sweden4 sites

Sahlgrenska University Hospital
Gothenburg
Skane University Hospital, Lund, Sweden
Lund, 22185
Karolinska University Hospital
Stockholm
Uppsala University Hospital
Uppsala, 75185

Other trials in Sweden

Austria3 sites

Graz University Hospital
Graz, A-8036
Innsbruck University Hospital
Innsbruck, A-6020
Medical University of Vienna
Vienna, A-1090

Other trials in Austria

Denmark2 sites

Aarhus University Hospital
Aarhus, DK-8200
Rigshospitalet - Copenhagen University Hospital
Copenhagen, DK-2100

Other trials in Denmark

Slovenia1 site

University Medical Centre
Ljubljana

Other trials in Slovenia

About this study

Official title: Rapid Endovascular Catheter Core Cooling Combined With Cold Saline as an Adjunct to Percutaneous Coronary Intervention For the Treatment of Acute Myocardial Infarction

Read the detailed description

Acute myocardial infarction (AMI) is the leading cause of mortality in the western world today. Although reperfusion of the ischemic myocardium is a prerequisite for myocardial salvage, it has been described that the reperfusion in itself may cause additional damage to the myocardium (reperfusion injury). In the safety \& feasibility trial RAPID MI-ICE we demonstrated that treatment of patients suffering from STEMI with 1-2 liters of cold saline and central venous catheter cooling with Philips InnerCool RTx Endovascular System prior to PCI was feasible, safe and resulted in a 38% reduction in infarct size/myocardium at risk. The aim of the present study is to confirm this finding in a larger multicenter trial.

The study is a randomized, controlled, evaluator blinded, multicenter trial enrolling 120 patients at ten sites.

Conditions: Myocardial Infarction, Myocardial Reperfusion Injury, Anterior Wall Myocardial Infarction, Inferior Wall Myocardial Infarction
Being tested: Cooling
Keywords: STEMI, primary PCI, Hypothermia, Endovascular cooling, Cardiac MRI
Medical subject headings: Myocardial Infarction, Myocardial Reperfusion Injury, Anterior Wall Myocardial Infarction, Inferior Wall Myocardial Infarction, ST Elevation Myocardial Infarction, Hypothermia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CoolingProcedure or surgery
Also called Hypothermia
1-2 liters of cold saline and central venous catheter cooling with Philips InnerCool RTx Endovascular System prior to PCI

Study groups in NCT01379261
Study group	Role	What they receive
Hypothermia treatment	Active comparator	1-2 liters of cold saline and central venous catheter cooling with Philips InnerCool RTx Endovascular System prior to PCI Receives: Procedure: Cooling
Standard treatment	No intervention	Standard treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

Myocardial infarct size (as a percentage of myocardium at risk) assessed by cardiac MRI.
Measured: At 4±2 days

Secondary outcomes (18)

Myocardial infarct size (as a percentage of myocardium at risk) both assessed by cardiac MRI at 4±2 days in the patients who are cooled and achieve a target temperature of < 35 C prior to PCI.
Measured: At 4±2 days
Myocardial infarct size (as a percentage of myocardium at risk) both assessed by cardiac MRI at 4±2 days in patients with an occluded and non-occluded IRA before PCI.
Measured: At 4±2 days
Myocardial infarct size (as a percentage of myocardium at risk) both assessed by cardiac MRI at 4±2 days in the per protocol population who are cooled according to protocol and meet inclusion criteria.
Measured: At 4±2 days
Myocardial infarct size (as a percentage of myocardium at risk) both assessed by cardiac MRI at 4±2 days in patients with anterior or inferior myocardial infarctions separately.
Measured: At 4±2 days
The effect of the hypothermia protocol on the incidence of death.
Measured: 45±15 days and 6 months.
Plasma level of high sensitivity Troponin T AUC through 48 hours and peak plasma level of high sensitivity Troponin T within 48 hours after AMI.
Measured: 48 hours
ST-segment resolution 1.5 hour after opening the IRA.
Measured: 1.5 hours
Coronary blood flow and coronary angiography at the index event estimated by TIMI coronary flow and coronary perfusion grading.
Measured: 2 hours
Plasma NT-proBNP levels at day 4±2.
Measured: Day 4±2.
Incidence of death at 1, 2, 3, 4 and 5 years.
Measured: 5 years
Myocardial infarct size (as a percentage of myocardium at risk) assessed by cardiac MRI at 6±1 months.
Measured: 6 months
Incidence of heart failure within 45±15 days.
Measured: 6 months
Incidence of pulmonary oedema.
Measured: 1 week
Incidence of infections
Measured: 1 week
Incidence of bleedings
Measured: 1 week
The effect of the hypothermia protocol on the incidence of recurrent MI.
Measured: 6 months
The effect of the hypothermia protocol on the incidence of emergent stent revascularisation.
Measured: 6 months
The effect of the hypothermia protocol on the incidence of any hospitalisation.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2011Nov 2013

First posted23 Jun 2011 (estimated)
Study startJun 2011
Primary completionSep 2013
Study completionNov 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
More trials run by Region SkaneThe sponsor's other registered studies.
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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01379261
Sponsor's protocol ID: CHILL-MI
Acronym: CHILL-MI
Status last verified: Nov 2014
First submitted: 21 Jun 2011
Last updated: 6 Nov 2014
Results posted: No
Data monitoring committee: Yes

Publications

Nordlund D, Heiberg E, Carlsson M, Frund ET, Hoffmann P, Koul S, Atar D, Aletras AH, Erlinge D, Engblom H, Arheden H. Extent of Myocardium at Risk for Left Anterior Descending Artery, Right Coronary Artery, and Left Circumflex Artery Occlusion Depicted by Contrast-Enhanced Steady State Free Precession and T2-Weighted Short Tau Inversion Recovery Magnetic Resonance Imaging. Circ Cardiovasc Imaging. 2016 Jul;9(7):e004376. doi: 10.1161/CIRCIMAGING.115.004376.
PubMed 27412659
Engblom H, Tufvesson J, Jablonowski R, Carlsson M, Aletras AH, Hoffmann P, Jacquier A, Kober F, Metzler B, Erlinge D, Atar D, Arheden H, Heiberg E. A new automatic algorithm for quantification of myocardial infarction imaged by late gadolinium enhancement cardiovascular magnetic resonance: experimental validation and comparison to expert delineations in multi-center, multi-vendor patient data. J Cardiovasc Magn Reson. 2016 May 4;18(1):27. doi: 10.1186/s12968-016-0242-5.
PubMed 27145749
Tufvesson J, Carlsson M, Aletras AH, Engblom H, Deux JF, Koul S, Sorensson P, Pernow J, Atar D, Erlinge D, Arheden H, Heiberg E. Automatic segmentation of myocardium at risk from contrast enhanced SSFP CMR: validation against expert readers and SPECT. BMC Med Imaging. 2016 Mar 5;16:19. doi: 10.1186/s12880-016-0124-1.
PubMed 26946139
Erlinge D, Gotberg M, Noc M, Lang I, Holzer M, Clemmensen P, Jensen U, Metzler B, James S, Botker HE, Omerovic E, Koul S, Engblom H, Carlsson M, Arheden H, Ostlund O, Wallentin L, Klos B, Harnek J, Olivecrona GK. Therapeutic hypothermia for the treatment of acute myocardial infarction-combined analysis of the RAPID MI-ICE and the CHILL-MI trials. Ther Hypothermia Temp Manag. 2015 Jun;5(2):77-84. doi: 10.1089/ther.2015.0009. Epub 2015 May 18.
PubMed 25985169
Erlinge 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 24509284
Erlinge D, Gotberg M, Grines C, Dixon S, Baran K, Kandzari D, Olivecrona GK. A pooled analysis of the effect of endovascular cooling on infarct size in patients with ST-elevation myocardial infarction. EuroIntervention. 2013 Apr 22;8(12):1435-40. doi: 10.4244/EIJV8I12A217.
PubMed 23164721

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Myocardial Infarction trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Rapid Endovascular Catheter Core Cooling Combined With Cold Saline as an Adjunct to Percutaneous Coronary Intervention For the Treatment of Acute Myocardial Infarction
ClinicalTrials.gov ID: NCT01379261
Acronym / sponsor ID: CHILL-MI / CHILL-MI
Conditions: Myocardial Infarction, Myocardial Reperfusion Injury, Anterior Wall Myocardial Infarction, Inferior Wall Myocardial Infarction
Keywords: STEMI, primary PCI, Hypothermia, Endovascular cooling, Cardiac MRI
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Region SkaneUniversity, hospital or other
Collaborators: Philips Healthcare, Lund University, Uppsala University
Study start: Jun 2011
Primary completion: Sep 2013 (actual)
Study completion: Nov 2013 (actual)
First posted: 23 Jun 2011 (estimated)
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.

Detailed description

The study is a randomized, controlled, evaluator blinded, multicenter trial enrolling 120 patients at ten sites.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Hypothermia treatment	Active comparator	Procedure: Cooling1-2 liters of cold saline and central venous catheter cooling with Philips InnerCool RTx Endovascular System prior to PCI
Standard treatment	No intervention	–Standard treatment

Who may qualify

Ages: 18 to 79 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Clinical symptoms and signs of myocardial infarction and have a 12-lead ECG providing evidence of an ongoing acute myocardial infarction, involving a large area of myocardium, as defined by the following ECG criteria. The ECG changes should be present upon arrival to the cath lab:
Present to the study PCI lab within six (6) hours of the onset of acute cardiac ischemic signs or symptoms (such as chest pain or pressure, arm or jaw pain, dyspnea, nausea/vomiting, or syncope).
Be a candidate for PCI and have PCI planned as the immediate intervention.
Be willing and able to comply with study procedures, including returning for the MRI scan at 4 ±2 days and be available for additional follow up Subject understands study procedures and agrees to participate in the study by giving written informed consent.
Be in Killips Class I.

Key exclusion criteria (22 listed)

Age less than eighteen (<18) years of age
Age greater than or equal to eighty (80) years of age
Are pregnant.
Having an aortic dissection
History of a prior large myocardial infarct or an infarct in the same segment that is currently affected.

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
CoolingAlso: Hypothermia1-2 liters of cold saline and central venous catheter cooling with Philips InnerCool RTx Endovascular System prior to PCI	Procedure or surgery	Hypothermia treatment

Primary outcome

Myocardial infarct size (as a percentage of myocardium at risk) assessed by cardiac MRI.
Time frame: At 4±2 days

18 secondary outcomes

Myocardial infarct size (as a percentage of myocardium at risk) both assessed by cardiac MRI at 4±2 days in the patients who are cooled and achieve a target temperature of < 35 C prior to PCI.
Time frame: At 4±2 days
Myocardial infarct size (as a percentage of myocardium at risk) both assessed by cardiac MRI at 4±2 days in patients with an occluded and non-occluded IRA before PCI.
Time frame: At 4±2 days
Myocardial infarct size (as a percentage of myocardium at risk) both assessed by cardiac MRI at 4±2 days in the per protocol population who are cooled according to protocol and meet inclusion criteria.
Time frame: At 4±2 days
Myocardial infarct size (as a percentage of myocardium at risk) both assessed by cardiac MRI at 4±2 days in patients with anterior or inferior myocardial infarctions separately.
Time frame: At 4±2 days
The effect of the hypothermia protocol on the incidence of death.
Time frame: 45±15 days and 6 months.
Plasma level of high sensitivity Troponin T AUC through 48 hours and peak plasma level of high sensitivity Troponin T within 48 hours after AMI.
Time frame: 48 hours
ST-segment resolution 1.5 hour after opening the IRA.
Time frame: 1.5 hours
Coronary blood flow and coronary angiography at the index event estimated by TIMI coronary flow and coronary perfusion grading.
Time frame: 2 hours
Plasma NT-proBNP levels at day 4±2.
Time frame: Day 4±2.
Incidence of death at 1, 2, 3, 4 and 5 years.
Time frame: 5 years
Myocardial infarct size (as a percentage of myocardium at risk) assessed by cardiac MRI at 6±1 months.
Time frame: 6 months
Incidence of heart failure within 45±15 days.
Time frame: 6 months
Incidence of pulmonary oedema.
Time frame: 1 week
Incidence of infections
Time frame: 1 week
Incidence of bleedings
Time frame: 1 week
The effect of the hypothermia protocol on the incidence of recurrent MI.
Time frame: 6 months
The effect of the hypothermia protocol on the incidence of emergent stent revascularisation.
Time frame: 6 months
The effect of the hypothermia protocol on the incidence of any hospitalisation.
Time frame: 6 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2014.
Derived from this study: PubMed 27412659Nordlund D, Heiberg E, Carlsson M, Frund ET, Hoffmann P, Koul S, Atar D, Aletras AH, Erlinge D, Engblom H, Arheden H. Extent of Myocardium at Risk for Left Anterior Descending Artery, Right Coronary Artery, and Left Circumflex Artery Occlusion Depicted by Contrast-Enhanced Steady State Free Precession and T2-Weighted Short Tau Inversion Recovery Magnetic Resonance Imaging. Circ Cardiovasc Imaging. 2016 Jul;9(7):e004376. doi: 10.1161/CIRCIMAGING.115.004376.
Derived from this study: PubMed 27145749Engblom H, Tufvesson J, Jablonowski R, Carlsson M, Aletras AH, Hoffmann P, Jacquier A, Kober F, Metzler B, Erlinge D, Atar D, Arheden H, Heiberg E. A new automatic algorithm for quantification of myocardial infarction imaged by late gadolinium enhancement cardiovascular magnetic resonance: experimental validation and comparison to expert delineations in multi-center, multi-vendor patient data. J Cardiovasc Magn Reson. 2016 May 4;18(1):27. doi: 10.1186/s12968-016-0242-5.
Derived from this study: PubMed 26946139Tufvesson J, Carlsson M, Aletras AH, Engblom H, Deux JF, Koul S, Sorensson P, Pernow J, Atar D, Erlinge D, Arheden H, Heiberg E. Automatic segmentation of myocardium at risk from contrast enhanced SSFP CMR: validation against expert readers and SPECT. BMC Med Imaging. 2016 Mar 5;16:19. doi: 10.1186/s12880-016-0124-1.
Derived from this study: PubMed 25985169Erlinge D, Gotberg M, Noc M, Lang I, Holzer M, Clemmensen P, Jensen U, Metzler B, James S, Botker HE, Omerovic E, Koul S, Engblom H, Carlsson M, Arheden H, Ostlund O, Wallentin L, Klos B, Harnek J, Olivecrona GK. Therapeutic hypothermia for the treatment of acute myocardial infarction-combined analysis of the RAPID MI-ICE and the CHILL-MI trials. Ther Hypothermia Temp Manag. 2015 Jun;5(2):77-84. doi: 10.1089/ther.2015.0009. Epub 2015 May 18.
Derived from this study: 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 23164721Erlinge D, Gotberg M, Grines C, Dixon S, Baran K, Kandzari D, Olivecrona GK. A pooled analysis of the effect of endovascular cooling on infarct size in patients with ST-elevation myocardial infarction. EuroIntervention. 2013 Apr 22;8(12):1435-40. doi: 10.4244/EIJV8I12A217.

Related trials for Myocardial Infarction

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Coronary Artery Disease, Coronary Artery Bypass Grafting
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
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Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
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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.

David Erlinge, MD PhD principal investigator

Department of Cardiology, Skane University Hospital, Lund, Sweden

Göran K Olivecrona, MD PhD principal investigator

Department of Cardiology, Skane University Hospital, Lund, Sweden

Anthony Mullins study director

Philips Healthcare, San Diego, CA, USA

10 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Cooling in people with Myocardial Infarction and Myocardial Reperfusion Injury, run by Region Skane at 10 sites in 4 countries.

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 7 inclusion and 22 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: finished, as of the sponsor's last update on 6 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Sweden, Austria, Denmark, Slovenia. 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Myocardial infarct size (as a percentage of myocardium at risk) assessed by cardiac MRI. (time frame: At 4±2 days). 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 NCT01379261, which also lists 6 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 Nov 2014.