NCT02445885

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
156mo left

Started May 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress46%
May 2015Mar 2039

Study Start

First participant enrolled

May 1, 2015

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 8, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 15, 2015

Completed
10.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
13.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2039

Expected
Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

10.3 years

First QC Date

May 8, 2015

Last Update Submit

March 31, 2026

Conditions

Ischemic Heart DiseaseST-segment Elevation Myocardial Infarction

Keywords

Myocardial infarctionLate presentersPrimary percutaneous coronary interventionReperfusionAngioplastyDuration of ischemiaCardiovascular magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Final infarct size

    3 months

  • Final myocardial salvage index

    1-2 days

  • Acute infarct size

    1-2 days

  • Microvascular obstruction (MVO)

    1-2 days

  • Left Ventricular Ejection Fraction (LVEF)

    1-2 days and 3 months

Other Outcomes (1)

  • Left Ventricular (LV) volumes

    1-2 days and 3 months

Study Arms (2)

Acute PCI

EXPERIMENTAL

Acute re-opening of the occluded coronary artery including premedication as for primary PCI within 12 hours

Procedure: PCI

Subacute PCI

ACTIVE COMPARATOR

Standard subacute re-opening of the occluded coronary artery including premedication as for subacute PCI within 72 hours

Procedure: PCI

Interventions

PCIPROCEDURE

Guideline directed Percutaneous Coronary Intervention

Acute PCISubacute PCI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, Capital Region, 2100, Denmark

RECRUITING

Related Publications (4)

  • 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.

    PMID: 20716739BACKGROUND

  • 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.

    PMID: 19442942BACKGROUND

  • 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.

    PMID: 19357105RESULT

  • 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.

    PMID: 15956631RESULT

MeSH Terms

Conditions

Myocardial IschemiaST Elevation Myocardial InfarctionMyocardial Infarction

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Lars Nepper-Christensen, MD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lars Nepper-Christensen, MD

CONTACT

+4535457586lars.nepper@gmail.com

Thomas Engstrøm, MDSci, PhD

CONTACT

+4535452017thomas.engstroem@regionh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief Consultant

Study Record Dates

First Submitted

May 8, 2015

First Posted

May 15, 2015

Study Start

May 1, 2015

Primary Completion

August 30, 2025

Study Completion (Estimated)

March 1, 2039

Last Updated

April 1, 2026

Record last verified: 2026-03

Locations

DK(1)