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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54745

Enrollment

650

Registered

2016-12-08

Start date

2017-12-28

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

(ST-elevation) myocardial infarction heart attack

Interventions

A total of 1146 patients will be randomized in a 1:1 fashion to either active treatment or control. In the active treatment group, complete revascularization of non-infarct coronary lesions >=50% an

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
The primary end point of the study consists of a combined outcome of all-cause mortality, recurrent MI and hospitalization for heart failure at 3 years follow-up.	—

Secondary

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

Measure

Time frame

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

—

Countries

Australia, Belgium, Czech Republic, Denmark, Germany, Italy, Luxembourg, Netherlands, New Zealand, Portugal, Slovenia, Spain, Switzerland, Thailand, United Kingdom

Contacts

Public ContactR Nijveldt

Radboud Universitair Medisch Centrum

onderzoek.cardio@radboudumc.nl024 361 45 33

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: May 1, 2026