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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute PCI | Experimental | Acute re-opening of the occluded coronary artery including premedication as for primary PCI within 12 hours |
|
| Subacute PCI | Active Comparator | Standard subacute re-opening of the occluded coronary artery including premedication as for subacute PCI within 72 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCI | Procedure | Guideline directed Percutaneous Coronary Intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1-2 days |
| Measure | Description | Time Frame |
|---|---|---|
| Final infarct size | Please see above | 3 months |
| Final myocardial salvage index | As for primary endpoint but IZ is measured within the index admission |
| Measure | Description | Time Frame |
|---|---|---|
| Left Ventricular (LV) volumes | 1-2 days and 3 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars Nepper-Christensen, MD | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Copenhagen | Capital Region | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20716739 | Background | 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. | |
| 19442942 | Background |
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| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D000072657 | ST Elevation Myocardial Infarction |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
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| 1-2 days |
| Acute infarct size | 1-2 days |
| Microvascular obstruction (MVO) | 1-2 days |
| Left Ventricular Ejection Fraction (LVEF) | Measured by MRI | 1-2 days and 3 months |
| All-cause mortality | Mortality due to any cause | Until last included patient has been followed for 180 days |
| All-cause mortality and hospitalization for heart failure | Until last included patient has been followed for 180 days |
| All-cause mortality, hospitalization for heart failure and malignant arrhythmia | Until last included patient has been followed for 180 days |
| Cardiac death | Death caused by a malfunction of the heart muscle or electrical system. | Until last included patient has been followed for 180 days |
| Hospitalization for heart failure | Until last included patient has been followed for 180 days |
| Spontaneous myocardial infarction | Until last included patient has been followed for 180 days |
| Malignant arrhythmia | VF/VT or ICD activation | Until last included patient has been followed for 180 days |
| Unplanned revascularization | Any unplanned revascularization | Until last included patient has been followed for 180 days |
| Stroke | Any stroke or TIA | Until last included patient has been followed for 180 days |
| Carlsson 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. |
| 19357105 | Result | Busk 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. |
| 15956631 | Result | Schomig 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. |
| D007511 |
| Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |