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

Not Applicable

Recruiting

• Conditions: ST-segment Elevation Myocardial Infarction; Ischemic Heart Disease
• Interventions: Procedure: PCI

• Registration Number: NCT02445885
• Lead Sponsor: Thomas Engstrom

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.

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-08
• Study First Submitted QC: 2015-05-12
• Study First Posted: 2015-05-15
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-29
• Last Update Posted: 2023-03-30
• Primary Completion: 2024-03-01
• Study Completion: 2039-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acute PCI	PCI	Acute re-opening of the occluded coronary artery including premedication as for primary PCI within 12 hours
Subacute PCI	PCI	Standard subacute re-opening of the occluded coronary artery including premedication as for subacute PCI within 72 hours

Primary Outcome Measures

Name	Time	Method
Acute salvage index evaluated by MRI	1-2 days	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

Secondary Outcome Measures

Name	Time	Method
Final infarct size	3 months	Please see above
Microvascular obstruction (MVO)	1-2 days
Final myocardial salvage index	1-2 days	As for primary endpoint but IZ is measured within the index admission
Left Ventricular Ejection Fraction (LVEF)	1-2 days and 3 months	Measured by MRI
Acute infarct size	1-2 days

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Capital Region, Denmark