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Acute Myocardial InfarctioniMODERNNCT03298659

iFR Guided Multi-vessel Revascularization During Percutaneous Coronary Intervention for Acute Myocardial Infarction

A study testing iFR and CMR in people with Acute Myocardial Infarction and Multi Vessel Coronary Artery Disease, run by Radboud University Medical Center at 1 site in Netherlands.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

In patients with acute ST-elevation myocardial infarction (STEMI), 40-60% have multi-vessel disease with an increased cardiovascular morbidity and mortality. Although it is not recommended to revascularize noninfarct lesions during the acute intervention, recent investigations suggest the opposite and show improved… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
iFR and CMR
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,146 participants
Where
1 siteNetherlands
Study dates
21 Dec 2017to 31 May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • History of ST-elevation myocardial infarction or coronary artery bypass graft
  • Hemodynamic instability, respiratory failure, Kilips class ≥III
  • Known GFR<30 ml/min
  • Known contra-indications for stress CMR (e.g.: severe claustrophobia, metal implants, severe renal failure, severe astma)
  • Refusal or inability to provide informed consent
  • Life expectancy due to noncardiovascular co-morbidity of less than 12 months
Show all 11Show fewer
  • Chronic total occlusion
  • Left main stem stenosis (>50%)
  • Residual noninfarct lesion in infarct coronary artery
  • Complex noninfarct target lesions
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Radboudumc

    Nijmegen

Other trials in Netherlands

About this study

Official title: Instantaneous Wave-free Ratio Guided Multi-vessel revascularizatiOn During Percutaneous Coronary intervEntion for Acute myocaRdial iNfarction (iMODERN)

In patients with acute ST-elevation myocardial infarction (STEMI), 40-60% have multi-vessel disease with an increased cardiovascular morbidity and mortality. Although it is not recommended to revascularize noninfarct lesions during the acute intervention, recent investigations suggest the opposite and show improved outcome after direct revascularization of noninfarct lesions. It is undesirable to risk procedure-related complications by treating noninfarct lesions without impaired flow. It is currently unknown whether pressure guided revascularization of noninfarct lesions in the acute phase improves outcome compared to the current guidelines.

The iMODERN trial aims to compare an iFR-guided intervention of noninfarct lesions during the acute intervention with a deferred stress perfusion CMR-guided strategy during the outpatient follow-up, to determine the optimal therapeutic approach for STEMI patients with multivessel lesions.

Read the detailed description

Study design:

The study is a prospective, randomized controlled, multicentre study.

Study population:

The research population will be recruited from the general patient population presenting with an acute STEMI. Patients treated with successful primary PCI and one or more additional significant coronary lesions in another coronary artery will be enrolled in the study. A total of 1,146 consecutive patients will be included.

Intervention:

The patients will be randomized 1:1, to (A) an active treatment arm with complete, iFR-guided revascularization of every noninfarct coronary lesion >50% and iFR ≤0.89; (B) a deferred treatment arm, in which patients will undergo an adenosine stress perfusion CMR scan within 6 weeks after STEMI, with revascularization of the noninfarct coronary lesions with associated perfusion defects.

Main study parameters/endpoints:

The primary end point consists of a combined outcome, including all-cause death, recurrent MI and hospitalization for heart failure at 3 years follow-up.

Duration:

Anticipated recruitment is 2 years. Follow-up will be performed at 6 months, 12 months, 3 years and 5 years.

Being tested
iFR, CMR

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • iFRDiagnostic test

    Treatment guided by instantaneous wave-free ratio

  • CMRDiagnostic test

    Treatment guided by stress perfusion CMR

Study groups in NCT03298659
Study groupRoleWhat they receive
Active iFR-guided revascularizationExperimentalDecision to treat the nonculprit coronary stenosis if there is a significant pressure drop over the stenosis, as measured by intracoronary iFR assessment
Receives: Diagnostic Test: iFR
Deferred CMR-guided revascularizationActive comparatorDecision to treat the nonculprit coronary stenosis if perfusion defect visible in corresponding coronary territory as visualized on stress perfusion CMR imaging
Receives: Diagnostic Test: CMR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite end point of Major Adverse Cardiac Events

    All-cause death, recurrent myocardial infarction and hospitalization for heart failure

    Measured: 3 years

Secondary outcomes (13)

  1. Composite end point of Major Adverse Cardiac Events

    All-cause death, recurrent myocardial infarction and hospitalization for heart failure

    Measured: 6 months, 12 months, and 5 years

  2. Cardiac death

    Death from cardiovascular causes

    Measured: 6 months, 12 months, 3 years, and 5 years

  3. Myocardial infarction

    Myocardial infarction

    Measured: 6 months, 12 months, 3 years, and 5 years

  4. Stroke

    Stroke

    Measured: 6 months, 12 months, 3 years, and 5 years

  5. Transient ischemic attack

    TIA

    Measured: 6 months, 12 months, 3 years, and 5 years

  6. Major bleeding

    Haemorrhagic complications

    Measured: 6 months, 12 months, 3 years, and 5 years

  7. Unstable angina

    Unstable angina including ECG-changes

    Measured: 6 months, 12 months, 3 years, and 5 years

  8. Revascularization

    Any coronary artery revascularization

    Measured: 6 months, 12 months, 3 years, and 5 years

  9. Coronary angiography

    Coronary angiography

    Measured: 6 months, 12 months, 3 years, and 5 years

  10. Stent thrombosis

    Stent thrombosis

    Measured: 6 months, 12 months, 3 years, and 5 years

  11. Target lesion failure

    Failure and/or revascularization by percutaneous or surgical methods of the target lesion, including cardiac death, MI, or clinically-driven target lesion revascularization

    Measured: 6 months, 12 months, 3 years, and 5 years

  12. Cost effectiveness analysis

    Costs related to complete, iFR-guided revascularization versus CMR-guided treatment, including cost utility analysisfrom a societal perspective with the costs per prevented cardiac eventand the costs per QALY as the respective primary health economic outcomes (using a quality of life questionnaire and a health care resource use questionnaire)

    Measured: 6 and 12 months, 3 and 5 years

  13. Quality of life

    Quality of life is measured by standardized questionnaires, i.e. SAQ, EQ-5D-5L and Minnesota heart failure questionnaire, at 6 and 12 months, 3 and 5 years

    Measured: From enrolment to 6 and 12 months, 3 and 5 years follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2017
  2. Study start21 Dec 2017
  3. Primary completion28 Oct 2025
  4. Study completion31 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Model description
1:1 randomization to (A) an active treatment arm with complete, iFR-guided revascularization of every noninfarct coronary lesion \>50% and iFR ≤0.89; or (B) a deferred treatment arm, in which patients will undergo an adenosine stress perfusion CMR scan within 6 weeks after STEMI, with revascularization of the noninfarct coronary lesions with associated perfusion defects.
Masking
None (open label)
Enrolment
1,146 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03298659
Sponsor's protocol ID
NL60107.029.16
Acronym
iMODERN
Status last verified
Aug 2026
First submitted
18 Sep 2017
Last updated
14 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Nijveldt R, Maeng M, Beijnink CWH, Piek JJ, Al-Lamee RK, Raposo L, Baptista SB, Escaned J, Davies J, Klem I, Yosofi B, van Geuns RM, Frederiksen CA, Jakobsen L, El Barzouhi A, van der Heijden DJ, Ilhan M, Rasoul S, Brinckman S, Saraber C, Jones DA, Petersen SE, Podlesnikar T, Bunc M, Beijk MAM, Piers LH, van Rees JB, Seligman H, Cole G, Iglesias JF, Degrauwe S, van 't Hof AWJ, Lipsic E, Pundziute-do Prado G, Chattranukulchai P, Rodriguez-Palomares JF, Rigger J, Meuwissen M, Kleijn L, Pereira B, Monti L, van der Schaaf RJ, Sanchis J, Belli G, Tijssen JGP, Thim T, van Royen N; iMODERN Investigators. Immediate or Deferred Nonculprit-Lesion PCI in Myocardial Infarction. N Engl J Med. 2026 Mar 5;394(10):958-968. doi: 10.1056/NEJMoa2512918. Epub 2025 Oct 28.

    PubMed 41159879

  • Ong P, Martinez Pereyra V, Sechtem U, Bekeredjian R. Management of patients with ST-segment myocardial infarction and multivessel disease: what are the options in 2022? Coron Artery Dis. 2022 Sep 1;33(6):485-489. doi: 10.1097/MCA.0000000000001157. Epub 2022 Jul 11.

    PubMed 35811565

  • Beijnink CWH, Thim T, van der Heijden DJ, Klem I, Al-Lamee R, Vos JL, Koop Y, Dijkgraaf MGW, Beijk MAM, Kim RJ, Davies J, Raposo L, Baptista SB, Escaned J, Piek JJ, Maeng M, van Royen N, Nijveldt R. Instantaneous wave-free ratio guided multivessel revascularisation during percutaneous coronary intervention for acute myocardial infarction: study protocol of the randomised controlled iMODERN trial. BMJ Open. 2021 Jan 15;11(1):e044035. doi: 10.1136/bmjopen-2020-044035.

    PubMed 33452200

Questions about this trial

What is this clinical trial studying?

A study testing iFR and CMR in people with Acute Myocardial Infarction and Multi Vessel Coronary Artery Disease, run by Radboud University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite end point of Major Adverse Cardiac Events (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03298659, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.

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