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

Sponsor

Thomas Engstrom (Other)

Overall Status

Recruiting

CT.gov ID

NCT02445885

Collaborator

(none)

150

Enrollment

Location

Arms

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Heart Disease ST-segment Elevation Myocardial Infarction	Procedure: PCI	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2015

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Other Outcome Measures

Left Ventricular (LV) volumes [1-2 days and 3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.