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

Ischemic Heart Disease Clinical Trial

— LATE-MI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02445885
• Other study ID #: LATE-MI
• Status: Recruiting
• Phase: N/A
• Start date: May 2015
• Est. completion date: March 1, 2039

Study information

• Verified date: March 2023
• Source: Rigshospitalet, Denmark
• Contact: Lars Nepper-Christensen, MD
• Phone: +4535457586
• Email: lars.nepper[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

This study aims to investigate whether acute intervention is superior to subacute intervention in these patients.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 1, 2039
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Infarction
• Ischemic Heart Disease
• Myocardial Infarction
• Myocardial Ischemia
• ST Elevation Myocardial Infarction
• ST-segment Elevation Myocardial Infarction

Intervention

Procedure:
• PCI
Guideline directed Percutaneous Coronary Intervention

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen	Capital Region

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Engstrom

Country where clinical trial is conducted

Denmark, 

References & Publications (4)

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 — View 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. — View 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 Evaluat — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Left Ventricular (LV) volumes		1-2 days and 3 months
Primary	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
Secondary	Final infarct size	Please see above	3 months
Secondary	Final myocardial salvage index	As for primary endpoint but IZ is measured within the index admission	1-2 days
Secondary	Acute infarct size		1-2 days
Secondary	Microvascular obstruction (MVO)		1-2 days
Secondary	Left Ventricular Ejection Fraction (LVEF)	Measured by MRI	1-2 days and 3 months