Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03298659
Recruitment Status : Recruiting
First Posted : October 2, 2017
Last Update Posted : May 2, 2019
Sponsor:
Collaborators:
Volcano Europe BVBA/SPRL
Biotronik AG
Stichting Life Sciences & Health
Duke Cardiovascular Magnetic Resonance Center
Information provided by (Responsible Party):
Radboud University

Tracking Information
First Submitted Date  ICMJE September 18, 2017
First Posted Date  ICMJE October 2, 2017
Last Update Posted Date May 2, 2019
Actual Study Start Date  ICMJE December 21, 2017
Estimated Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2017)
Composite end point of Major Adverse Cardiac Events [ Time Frame: 12 months ]
All-cause death, recurrent myocardial infarction and hospitalization for heart failure
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2017)
  • All cause mortality [ Time Frame: 6 and 12 months, 3 and 5 years ]
    All cause mortality at 6 and 12 months, 3 and 5 years
  • Cardiovascular mortality [ Time Frame: 6 and 12 months, 3 and 5 years ]
    Cardiovascular mortality at 6 and 12 months, 3 and 5 years
  • Myocardial infarction [ Time Frame: 6 and 12 months, 3 and 5 years ]
    Myocardial infarction at 6 and 12 months, 3 and 5 years
  • Cerebral events [ Time Frame: 6 and 12 months, 3 and 5 years ]
    Stroke and transient ischemic attack
  • Major bleeding [ Time Frame: 6 months ]
    Haemorrhagic complications
  • Unstable angina [ Time Frame: 6 and 12 months, 3 and 5 years ]
    Unstable angina including ECG-changes at 6 and 12 months, 3 and 5 years
  • Coronary angiography [ Time Frame: 6 and 12 months, 3 and 5 years ]
    Coronary angiography at 6 and 12 months, 3 and 5 years
  • Revascularization [ Time Frame: 6 and 12 months, 3 and 5 years ]
    Any revascularization at 6 and 12 months, 3 and 5 years
  • Target lesion failure [ Time Frame: 6 and 12 months, 3 and 5 years ]
    Failure and/or revascularization by percutaneous or surgical methods of the target lesion
  • Stent thrombosis [ Time Frame: 6 and 12 months, 3 and 5 years ]
    Stent thrombosis at 6 and 12 months, 3 and 5 years
  • Cost effectiveness analysis [ Time Frame: 6 and 12 months, 3 and 5 years ]
    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)
  • Quality of life [ Time Frame: 6 and 12 months, 3 and 5 years ]
    Quality of life questionnaires, i.e. SAQ, EQ-5D-5L and Minnesota heart failure questionnaire, at 6 and 12 months, 3 and 5 years
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE iFR Guided Multi-vessel Revascularization During Percutaneous Coronary Intervention for Acute Myocardial Infarction
Official Title  ICMJE Instantaneous Wave-free Ratio Guided Multi-vessel revascularizatiOn During Percutaneous Coronary intervEntion for Acute myocaRdial iNfarction (iMODERN)
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.

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 12 months follow-up.

Duration:

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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Acute Myocardial Infarction
  • Multi Vessel Coronary Artery Disease
Intervention  ICMJE
  • Diagnostic Test: iFR
    Treatment guided by instantaneous wave-free ratio
  • Diagnostic Test: CMR
    Treatment guided by stress perfusion CMR
Study Arms  ICMJE
  • Experimental: Active iFR-guided revascularization
    Decision to treat the nonculprit coronary stenosis if there is a significant pressure drop over the stenosis, as measured by intracoronary iFR assessment
    Intervention: Diagnostic Test: iFR
  • Active Comparator: Deferred CMR-guided revascularization
    Decision to treat the nonculprit coronary stenosis if perfusion defect visible in corresponding coronary territory as visualized on stress perfusion CMR imaging
    Intervention: Diagnostic Test: CMR
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 26, 2017)
1146
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2025
Estimated Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Robin Nijveldt, MD +31243614533 Robin@Nijveldt.net
Contact: Stefaan Van der Meulen, MSc +32477984154 svandermeulen@syntactx.com
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03298659
Other Study ID Numbers  ICMJE NL60107.029.16
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Radboud University
Study Sponsor  ICMJE Radboud University
Collaborators  ICMJE
  • Volcano Europe BVBA/SPRL
  • Biotronik AG
  • Stichting Life Sciences & Health
  • Duke Cardiovascular Magnetic Resonance Center
Investigators  ICMJE Not Provided
PRS Account Radboud University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP