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

NCT03298659 | Active Not Recruiting DMC

• 1 other identifier: NL60107.029.16
• Study Type: interventional
• Target: 1,146
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Acute Myocardial Infarction; Multi Vessel Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Composite end point of Major Adverse Cardiac Events

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

  3 years

Secondary Outcomes (12)

• All cause mortality

  6 and 12 months, 3 and 5 years

• Cardiovascular mortality

  6 and 12 months, 3 and 5 years

• Myocardial infarction

  6 and 12 months, 3 and 5 years

• Cerebral events

  6 and 12 months, 3 and 5 years

• Major bleeding

  6 months

Study Arms (2)

Active iFR-guided revascularization

EXPERIMENTAL

Decision to treat the nonculprit coronary stenosis if there is a significant pressure drop over the stenosis, as measured by intracoronary iFR assessment

Diagnostic Test: iFR

Deferred CMR-guided revascularization

ACTIVE COMPARATOR

Decision to treat the nonculprit coronary stenosis if perfusion defect visible in corresponding coronary territory as visualized on stress perfusion CMR imaging

Diagnostic Test: CMR

Interventions

iFR DIAGNOSTIC_TEST

Treatment guided by instantaneous wave-free ratio

Active iFR-guided revascularization

CMR DIAGNOSTIC_TEST

Treatment guided by stress perfusion CMR

Deferred CMR-guided revascularization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• History of myocardial infarction.
• 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.
• Chronic total occlusion.
• Left main stem stenosis (\>50%).
• Residual noninfarct lesion in infarct coronary artery.
• Complex (e.g. bifurcation) noninfarct target lesions.

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Volcano Europe BVBA/SPRL: collaborator
• Biotronik AG: collaborator
• Stichting Life Sciences & Health: collaborator
• Duke Cardiovascular Magnetic Resonance Center: collaborator

Study Sites (1)

Radboudumc

Nijmegen, Netherlands

Location

Related Publications (3)

• 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. 2025 Oct 28. doi: 10.1056/NEJMoa2512918. Online ahead of print.

  PMID: 41159879 DERIVED

• 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.

  PMID: 35811565 DERIVED

• 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.

  PMID: 33452200 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 18, 2017
• First Posted: October 2, 2017
• Study Start: December 21, 2017
• Primary Completion: May 31, 2025
• Study Completion (Estimated): May 31, 2027
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)