Late Reperfusion With Percutaneous Coronary Intervention in Patients With ST-segment Elevation Myocardial Infarction (LATE-MI)

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.

Study Overview

• Status: Recruiting
• Conditions: Ischemic Heart Disease; ST-segment Elevation Myocardial Infarction
• Intervention / Treatment: Procedure: PCI

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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lars Nepper-Christensen, MD; Phone Number: +4535457586; Email: lars.nepper@gmail.com
• Study Contact Backup: Name: Thomas Engstrøm, MDSci, PhD; Phone Number: +4535452017; Email: thomas.engstroem@regionh.dk

Study Locations

• Denmark
  • Capital Region
    • Copenhagen, Capital Region, Denmark, 2100
      • Recruiting
      • Rigshospitalet
      • Contact: Lars Nepper-Christensen, MD
      • Contact: Thomas Engstrøm, DSci, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acute PCI; Acute re-opening of the occluded coronary artery including premedication as for primary PCI within 12 hours	Procedure: PCI; Guideline directed Percutaneous Coronary Intervention
Active Comparator: Subacute PCI; Standard subacute re-opening of the occluded coronary artery including premedication as for subacute PCI within 72 hours	Procedure: PCI; Guideline directed Percutaneous Coronary Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	Time Frame
Left Ventricular (LV) volumes	1-2 days and 3 months

Collaborators and Investigators

• Sponsor: Thomas Engstrom
• Investigators: Principal Investigator: Lars Nepper-Christensen, MD, Rigshospitalet, Denmark

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): March 1, 2039

Study Registration Dates

• First Submitted: May 8, 2015
• First Submitted That Met QC Criteria: May 12, 2015
• First Posted (Estimate): May 15, 2015

Study Record Updates

• Last Update Posted (Actual): March 30, 2023
• Last Update Submitted That Met QC Criteria: March 29, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Myocardial infarction; Angioplasty; Reperfusion; Primary percutaneous coronary intervention; Late presenters; Duration of ischemia; Cardiovascular magnetic resonance imaging
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Infarction; Infarction; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; ST Elevation Myocardial Infarction
• Other Study ID Numbers: LATE-MI