Rigshospitalet
Copenhagen, Capital Region, 2100, Denmark
NCT Number: NCT02445885
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Copenhagen, Capital Region, 2100, Denmark
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Guideline directed Percutaneous Coronary Intervention
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
Time frame: 3 months
Please see above
Time frame: 1-2 days
As for primary endpoint but IZ is measured within the index admission
Time frame: 1-2 days
Time frame: 1-2 days
Time frame: 1-2 days and 3 months
Measured by MRI
Time frame: Until last included patient has been followed for 180 days
Mortality due to any cause
Time frame: Until last included patient has been followed for 180 days
Time frame: Until last included patient has been followed for 180 days
Time frame: Until last included patient has been followed for 180 days
Death caused by a malfunction of the heart muscle or electrical system.
Time frame: Until last included patient has been followed for 180 days
Time frame: Until last included patient has been followed for 180 days
Time frame: Until last included patient has been followed for 180 days
VF/VT or ICD activation
Time frame: Until last included patient has been followed for 180 days
Any unplanned revascularization
Time frame: Until last included patient has been followed for 180 days
Any stroke or TIA
Time frame: 1-2 days and 3 months
Thomas Engstrom
Other
Acronym: LATE-MI
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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