Clinical trial NCT02445885: Late Reperfusion With Percutaneous Coronary Intervention in Patients With ST-segment Elevation Myocardial Infarction
Official title: Late Reperfusion With Percutaneous Coronary Intervention in Patients With ST-segment Elevation Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ischemic Heart Disease
ST-segment Elevation Myocardial Infarction
Keywords: Myocardial infarction
Late presenters
Primary percutaneous coronary intervention
Reperfusion
Angioplasty
Duration of ischemia
Cardiovascular magnetic resonance imaging
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2015-05-15
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acute salvage index evaluated by MRI
timeFrame: 1-2 days
Secondary outcomes:
measure: Final infarct size
timeFrame: 3 months
measure: Final myocardial salvage index
timeFrame: 1-2 days
measure: Acute infarct size
timeFrame: 1-2 days
measure: Microvascular obstruction (MVO)
timeFrame: 1-2 days
measure: Left Ventricular Ejection Fraction (LVEF)
timeFrame: 1-2 days and 3 months
Other outcomes:
measure: Left Ventricular (LV) volumes
timeFrame: 1-2 days and 3 months
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
state: Capital Region
Study officials:
affiliation: Rigshospitalet, Denmark
name: Lars Nepper-Christensen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.