instantaneous wave-free ratio guided multi-vessel revascularization during percutaneous coronary intervention for acute myocardial infarctio

Recruiting

• Conditions: (ST-elevation) myocardial infarction; heart attack; 10011082

• Registration Number: NL-OMON54745
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 550

Inclusion Criteria

- Age 18 years and older
- Clinical presentation of STEMI and successful primary PCI within 12 hours
from onset of symptoms
- One or more other, noninfarct coronary artery lesions of >50% stenosis and
feasible to
be revascularized (i.e. minimal diameter 2mm)

Exclusion Criteria

- History of ST-elevation myocardial infarction or coronary artery bypass graft
- Hemodynamic instability, respiratory failure, Kilips class >=III
- Refusal or inability to provide informed consent
- Life expectancy due to noncardiovascular co-morbidity of less than 12 months
- Chronic total occlusion
- Left main stem stenosis (>50%)
- Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary end point of the study consists of a combined outcome of all-cause<br /><br>mortality, recurrent MI and hospitalization for heart failure at 3 years<br /><br>follow-up.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- the primary end point at 6 and 12 months<br /><br>- Target lesion failure defined as the composite of cardiac death, myocardial<br /><br>infarction or clinically-driven target lesion revascularization by percutaneous<br /><br>or surgical methods at 12 months, 3 years and 5 years follow-up.<br /><br>- all-cause death, cardiac death, unstable angina, myocardial infarction,<br /><br>clinically-driven revascularization, stroke, major bleeding, coronary<br /><br>angiography, stent thrombosis at 12 months, 3 years and 5 years follow-up.<br /><br>- Cost-effectiveness and cost-utility analyses with the costs per prevented<br /><br>cardiac event (all-cause mortality, recurrent myocardial infarction and<br /><br>hospitalization for heart failure) and the costs per quality adjusted life year<br /><br>(QALY) as the respective primary health economic outcomes.</p><br>