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

T

Thomas Engstrom

Status

Enrolling

Conditions

Ischemic Heart Disease
ST-segment Elevation Myocardial Infarction

Treatments

Procedure: PCI

Study type

Interventional

Funder types

Other

Identifiers

NCT02445885
LATE-MI

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

150 participants in 2 patient groups

Acute PCI
Experimental group
Description:
Acute re-opening of the occluded coronary artery including premedication as for primary PCI within 12 hours
Treatment:
Procedure: PCI
Subacute PCI
Active Comparator group
Description:
Standard subacute re-opening of the occluded coronary artery including premedication as for subacute PCI within 72 hours
Treatment:
Procedure: PCI

Trial contacts and locations

0

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Central trial contact

Lars Nepper-Christensen, MD; Thomas Engstrøm, MDSci, PhD

Data sourced from clinicaltrials.gov

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