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Completed

NCT Number: NCT02445885

Late Reperfusion With Percutaneous Coronary Intervention in Patients With ST-segment Elevation Myocardial Infarction

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, Capital Region, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Inclusion criteria:
  • 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.

Exclusion criteria

  • 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
  • Chronic atrial fibrillation.
  • Previous Coronary Artery Bypass Surgery (CABG).
  • Pregnancy.
  • Other severe illness with life expectancy less than 1 year

Treatment and study plan

PCI

Procedure

Guideline directed Percutaneous Coronary Intervention

Primary outcomes

  1. 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

Secondary outcomes

  1. Final infarct size

    Time frame: 3 months

    Please see above

  2. Final myocardial salvage index

    Time frame: 1-2 days

    As for primary endpoint but IZ is measured within the index admission

  3. Acute infarct size

    Time frame: 1-2 days

  4. Microvascular obstruction (MVO)

    Time frame: 1-2 days

  5. Left Ventricular Ejection Fraction (LVEF)

    Time frame: 1-2 days and 3 months

    Measured by MRI

  6. All-cause mortality

    Time frame: Until last included patient has been followed for 180 days

    Mortality due to any cause

  7. All-cause mortality and hospitalization for heart failure

    Time frame: Until last included patient has been followed for 180 days

  8. All-cause mortality, hospitalization for heart failure and malignant arrhythmia

    Time frame: Until last included patient has been followed for 180 days

  9. Cardiac death

    Time frame: Until last included patient has been followed for 180 days

    Death caused by a malfunction of the heart muscle or electrical system.

  10. Hospitalization for heart failure

    Time frame: Until last included patient has been followed for 180 days

  11. Spontaneous myocardial infarction

    Time frame: Until last included patient has been followed for 180 days

  12. Malignant arrhythmia

    Time frame: Until last included patient has been followed for 180 days

    VF/VT or ICD activation

  13. Unplanned revascularization

    Time frame: Until last included patient has been followed for 180 days

    Any unplanned revascularization

  14. Stroke

    Time frame: Until last included patient has been followed for 180 days

    Any stroke or TIA

Other outcomes

  1. Left Ventricular (LV) volumes

    Time frame: 1-2 days and 3 months

Sponsors and collaborators

Lead sponsor

Thomas Engstrom

Other

Registry information

Acronym: LATE-MI

Important dates

Study start
2015
Primary completion
2025
Study completion
2026
First posted
May 15, 2015
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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