Ischemic Heart DiseaseLATE-MINCT02445885
Late Reperfusion With Percutaneous Coronary Intervention in Patients With ST-segment Elevation Myocardial Infarction
A study testing PCI in people with Ischemic Heart Disease and ST-segment Elevation Myocardial Infarction, run by Thomas Engstrom at 1 site in Denmark.
Trial summary
Although recommended therapy for patients with ST-segment elevation myocardial infarction is primary PCI, it remains unestablished whether patients with a symptom duration of more 12 hours benefit from acute revascularisation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Disease, ST-segment Elevation Myocardial Infarction
- What is being tested?
- PCI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteDenmark
- Study dates
- May 2015to 13 May 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients more than 18 years of age.
- STEMI > 12 hours and < 36 hours.
- Clinical stable, i.e. no on going angina, hemodynamically stable (systolic BP > 90) and Killip class < 3.
Who cannot join
- Clinical instability which requires an acute invasive strategy.
- Left main occlusion or multivessel disease which requires CABG.
- Previous Q-wave infarction in the current infarct related artery.
- Left Bundle Branch Block (LBBB).
- Severe renal insufficiency.
- Pacemaker
Show all 10Show fewer
- Chronic atrial fibrillation.
- Previous Coronary Artery Bypass Surgery (CABG).
- Pregnancy.
- Other severe illness with life expectancy less than 1 year
Trial locations and contacts
1 site in 1 country.
About this study
Although recommended therapy for patients with ST-segment elevation myocardial infarction is primary PCI, it remains unestablished whether patients with a symptom duration of more 12 hours benefit from acute revascularisation.
This study aims to investigate whether acute intervention is superior to subacute intervention in these patients.
Read the detailed description
The recommended therapy for patients with ST-segment elevation myocardial infarction (STEMI) is to restore normal coronary blood flow with timely reperfusion by percutaneous coronary intervention (PCI), and thereby minimize the extent of cell death and preserving cardiac function. The duration of ischemia and timely PCI are major determinants for the size of the myocardial infarction and prognosis. Thus, acute PCI should be performed within 12 hours after symptom onset. The effect of PCI and timing of PCI are, however, much more uncertain for late presenters who contact the health service > 12 hours from symptom. Thus, it is still unknown whether late presenters should be treated with acute PCI or medical treatment with delayed PCI (24-72 h after first medical contact).
The study investigates the effect on final salvage index evaluated by magnetic resonance imaging of acute PCI of late presenters.
The overall objective of the study is to investigate whether late presenters may benefit from acute PCI, and thus whether to extend the currently recommended time limit of 12 hours for acute PCI in patients with STEMI.
- Being tested
- PCI
- Keywords
- Myocardial infarction, Late presenters, Primary percutaneous coronary intervention, Reperfusion, Angioplasty, Duration of ischemia, Cardiovascular magnetic resonance imaging
- Medical subject headings
- Myocardial Ischemia, ST Elevation Myocardial Infarction, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCIProcedure or surgery
Guideline directed Percutaneous Coronary Intervention
| Study group | Role | What they receive |
|---|---|---|
| Acute PCI | Experimental | Acute re-opening of the occluded coronary artery including premedication as for primary PCI within 12 hours Receives: Procedure: PCI |
| Subacute PCI | Active comparator | Standard subacute re-opening of the occluded coronary artery including premedication as for subacute PCI within 72 hours Receives: Procedure: PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute salvage index evaluated by MRI
MRI within 48 timer after index admission will be used to measure are at risk (AAR, T2-weighted) and acute infarct size (IZ). Acute salvage index is (AAR-IZ)/AAR
Measured: 1-2 days
Secondary outcomes (14)
Final infarct size
Please see above
Measured: 3 months
Final myocardial salvage index
As for primary endpoint but IZ is measured within the index admission
Measured: 1-2 days
Acute infarct size
Measured: 1-2 days
Microvascular obstruction (MVO)
Measured: 1-2 days
Left Ventricular Ejection Fraction (LVEF)
Measured by MRI
Measured: 1-2 days and 3 months
All-cause mortality
Mortality due to any cause
Measured: Until last included patient has been followed for 180 days
All-cause mortality and hospitalization for heart failure
Measured: Until last included patient has been followed for 180 days
All-cause mortality, hospitalization for heart failure and malignant arrhythmia
Measured: Until last included patient has been followed for 180 days
Cardiac death
Death caused by a malfunction of the heart muscle or electrical system.
Measured: Until last included patient has been followed for 180 days
Hospitalization for heart failure
Measured: Until last included patient has been followed for 180 days
Spontaneous myocardial infarction
Measured: Until last included patient has been followed for 180 days
Malignant arrhythmia
VF/VT or ICD activation
Measured: Until last included patient has been followed for 180 days
Unplanned revascularization
Any unplanned revascularization
Measured: Until last included patient has been followed for 180 days
Stroke
Any stroke or TIA
Measured: Until last included patient has been followed for 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2015 (estimated)
- Study startMay 2015
- Primary completion1 Sep 2025
- Study completion13 May 2026
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 Ischemic Heart DiseaseStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Engstrom
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Thomas Engstrom, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Lars Nepper-Christensen, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02445885
- Sponsor's protocol ID
- LATE-MI
- Acronym
- LATE-MI
- Status last verified
- Jun 2026
- First submitted
- 8 May 2015
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Terkelsen CJ, Sorensen JT, Maeng M, Jensen LO, Tilsted HH, Trautner S, Vach W, Johnsen SP, Thuesen L, Lassen JF. System delay and mortality among patients with STEMI treated with primary percutaneous coronary intervention. JAMA. 2010 Aug 18;304(7):763-71. doi: 10.1001/jama.2010.1139.
PubMed 20716739Carlsson M, Ubachs JF, Hedstrom E, Heiberg E, Jovinge S, Arheden H. Myocardium at risk after acute infarction in humans on cardiac magnetic resonance: quantitative assessment during follow-up and validation with single-photon emission computed tomography. JACC Cardiovasc Imaging. 2009 May;2(5):569-76. doi: 10.1016/j.jcmg.2008.11.018.
PubMed 19442942Busk M, Kaltoft A, Nielsen SS, Bottcher M, Rehling M, Thuesen L, Botker HE, Lassen JF, Christiansen EH, Krusell LR, Andersen HR, Nielsen TT, Kristensen SD. Infarct size and myocardial salvage after primary angioplasty in patients presenting with symptoms for <12 h vs. 12-72 h. Eur Heart J. 2009 Jun;30(11):1322-30. doi: 10.1093/eurheartj/ehp113. Epub 2009 Apr 8.
PubMed 19357105Schomig A, Mehilli J, Antoniucci D, Ndrepepa G, Markwardt C, Di Pede F, Nekolla SG, Schlotterbeck K, Schuhlen H, Pache J, Seyfarth M, Martinoff S, Benzer W, Schmitt C, Dirschinger J, Schwaiger M, Kastrati A; Beyond 12 hours Reperfusion AlternatiVe Evaluation (BRAVE-2) Trial Investigators. Mechanical reperfusion in patients with acute myocardial infarction presenting more than 12 hours from symptom onset: a randomized controlled trial. JAMA. 2005 Jun 15;293(23):2865-72. doi: 10.1001/jama.293.23.2865.
PubMed 15956631
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Late Reperfusion With Percutaneous Coronary Intervention in Patients With ST-segment Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT02445885
- Acronym / sponsor ID
- LATE-MI / LATE-MI
- Keywords
- Myocardial infarction, Late presenters, Primary percutaneous coronary intervention, Reperfusion, Angioplasty, Duration of ischemia, Cardiovascular magnetic resonance imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Thomas EngstromUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 13 May 2026 (actual)
- First posted
- 15 May 2015 (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.
Although recommended therapy for patients with ST-segment elevation myocardial infarction is primary PCI, it remains unestablished whether patients with a symptom duration of more 12 hours benefit from acute revascularisation.
This study aims to investigate whether acute intervention is superior to subacute intervention in these patients.
Detailed description
The recommended therapy for patients with ST-segment elevation myocardial infarction (STEMI) is to restore normal coronary blood flow with timely reperfusion by percutaneous coronary intervention (PCI), and thereby minimize the extent of cell death and preserving cardiac function. The duration of ischemia and timely PCI are major determinants for the size of the myocardial infarction and prognosis. Thus, acute PCI should be performed within 12 hours after symptom onset. The effect of PCI and timing of PCI are, however, much more uncertain for late presenters who contact the health service > 12 hours from symptom. Thus, it is still unknown whether late presenters should be treated with acute PCI or medical treatment with delayed PCI (24-72 h after first medical contact).
The study investigates the effect on final salvage index evaluated by magnetic resonance imaging of acute PCI of late presenters.
The overall objective of the study is to investigate whether late presenters may benefit from acute PCI, and thus whether to extend the currently recommended time limit of 12 hours for acute PCI in patients with STEMI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute PCI | Experimental | Procedure: PCIAcute re-opening of the occluded coronary artery including premedication as for primary PCI within 12 hours |
| Subacute PCI | Active comparator | Procedure: PCIStandard subacute re-opening of the occluded coronary artery including premedication as for subacute PCI within 72 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients more than 18 years of age.
- STEMI > 12 hours and < 36 hours.
- Clinical stable, i.e. no on going angina, hemodynamically stable (systolic BP > 90) and Killip class < 3.
Key exclusion criteria (10 listed)
- Clinical instability which requires an acute invasive strategy.
- Left main occlusion or multivessel disease which requires CABG.
- Previous Q-wave infarction in the current infarct related artery.
- Left Bundle Branch Block (LBBB).
- Severe renal insufficiency.
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 |
|---|---|---|
| PCIGuideline directed Percutaneous Coronary Intervention | Procedure or surgery | Acute PCI, Subacute PCI |
Primary outcome
Acute salvage index evaluated by MRI
Time frame: 1-2 days
MRI within 48 timer after index admission will be used to measure are at risk (AAR, T2-weighted) and acute infarct size (IZ). Acute salvage index is (AAR-IZ)/AAR
14 secondary outcomes
Final infarct size
Time frame: 3 months
Final myocardial salvage index
Time frame: 1-2 days
Acute infarct size
Time frame: 1-2 days
Microvascular obstruction (MVO)
Time frame: 1-2 days
Left Ventricular Ejection Fraction (LVEF)
Time frame: 1-2 days and 3 months
All-cause mortality
Time frame: Until last included patient has been followed for 180 days
All-cause mortality and hospitalization for heart failure
Time frame: Until last included patient has been followed for 180 days
All-cause mortality, hospitalization for heart failure and malignant arrhythmia
Time frame: Until last included patient has been followed for 180 days
Cardiac death
Time frame: Until last included patient has been followed for 180 days
Hospitalization for heart failure
Time frame: Until last included patient has been followed for 180 days
Spontaneous myocardial infarction
Time frame: Until last included patient has been followed for 180 days
Malignant arrhythmia
Time frame: Until last included patient has been followed for 180 days
Unplanned revascularization
Time frame: Until last included patient has been followed for 180 days
Stroke
Time frame: Until last included patient has been followed for 180 days
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 3 Jun 2026.
- Background: PubMed 20716739Terkelsen CJ, Sorensen JT, Maeng M, Jensen LO, Tilsted HH, Trautner S, Vach W, Johnsen SP, Thuesen L, Lassen JF. System delay and mortality among patients with STEMI treated with primary percutaneous coronary intervention. JAMA. 2010 Aug 18;304(7):763-71. doi: 10.1001/jama.2010.1139.
- Background: PubMed 19442942Carlsson M, Ubachs JF, Hedstrom E, Heiberg E, Jovinge S, Arheden H. Myocardium at risk after acute infarction in humans on cardiac magnetic resonance: quantitative assessment during follow-up and validation with single-photon emission computed tomography. JACC Cardiovasc Imaging. 2009 May;2(5):569-76. doi: 10.1016/j.jcmg.2008.11.018.
- Results publication: PubMed 19357105Busk M, Kaltoft A, Nielsen SS, Bottcher M, Rehling M, Thuesen L, Botker HE, Lassen JF, Christiansen EH, Krusell LR, Andersen HR, Nielsen TT, Kristensen SD. Infarct size and myocardial salvage after primary angioplasty in patients presenting with symptoms for <12 h vs. 12-72 h. Eur Heart J. 2009 Jun;30(11):1322-30. doi: 10.1093/eurheartj/ehp113. Epub 2009 Apr 8.
- Results publication: PubMed 15956631Schomig A, Mehilli J, Antoniucci D, Ndrepepa G, Markwardt C, Di Pede F, Nekolla SG, Schlotterbeck K, Schuhlen H, Pache J, Seyfarth M, Martinoff S, Benzer W, Schmitt C, Dirschinger J, Schwaiger M, Kastrati A; Beyond 12 hours Reperfusion AlternatiVe Evaluation (BRAVE-2) Trial Investigators. Mechanical reperfusion in patients with acute myocardial infarction presenting more than 12 hours from symptom onset: a randomized controlled trial. JAMA. 2005 Jun 15;293(23):2865-72. doi: 10.1001/jama.293.23.2865.
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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.
Lars Nepper-Christensen, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCI in people with Ischemic Heart Disease and ST-segment Elevation Myocardial Infarction, run by Thomas Engstrom at 1 site in Denmark.
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 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: finished, as of the sponsor's last update on 3 Jun 2026. 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 Denmark. 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?
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?
Acute salvage index evaluated by MRI (time frame: 1-2 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 NCT02445885, 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 3 Jun 2026.