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Status unknownNCT02869906WAVEUpdated Aug 17, 2016

Instantaneous Wave-Free Ratio and Fractional Flow Reserve for the Assessment of Non Culprit Lesions in Patients With ST-segment Elevation Myocardial Infarction

An observational study in ST Segment Elevation Myocardial Infarction, sponsored by Azienda Ospedaliera San Camillo Forlanini. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-08-17.

Sponsored by Azienda Ospedaliera San Camillo Forlanini · Observational

The sponsor has not verified this record recently (last verified Aug 2016), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
All
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Study summary

Functional assessment of non-culprit lesions during percutaneous coronary intervention (PCI) in patients with acute coronary syndrome could improve risk stratification and shorten the duration of hospital stay by decreasing the need for additional non-invasive stress testing to detect residual myocardial ischemia. The investigators aimed to assess the reliability of the instantaneous wave-free ratio (iFR) and fractional flow reserve (FFR) measurements in non-culprit coronary lesions during the acute and subacute phase of ST-segment elevation myocardial infarction (STEMI).

Read the detailed description

BACKGROUND: Approximately 30% of patients who present with ST elevation myocardial infarction have multivessel coronary artery disease on angiography. Whether percutaneous coronary intervention (PCI) should be limited to the culprit lesion only or applied to all angiographically critical non-culprit lesions is still debatable. The FAME 2 study has shown that Fractional Flow Reserve (FFR)-guided PCI, with adenosine infusion, reduces the MACE compared to medical therapy alone. In fact, according to the recent ESC clinical guidelines, FFR guided PCI is in class I, evidence level A. Previous studies, have confirmed that FFR values of non-culprit coronary lesions in STEMI patients provided similar values in the acute phase compared to the subacute phase, 5-7 days after primary PCI. Consequently, it is possible to assess angiographically borderline non-culprit lesions during the acute phase and hence risk stratify STEMI patients, thus reducing the duration of hospital stay by decreasing the need for additional non-invasive stress testing to detect residual myocardial ischemia. However, the assessment of angiographically borderline lesions using FFR has its own limitations related to the use of adenosine, which increases the risk of bradyarrhythmias and high degree atrioventricular block, especially in the acute phase. This would make functional assessment of the non-culprit lesions not always possible during the acute phase.

Recently, a new functional algorithm, called "instantaneous wave-free ratio" (iFR) has been introduced. Similar to FFR, it gives a functional assessment of coronary lesions by measuring the trans-stenotic gradient during ventricular diastole, where intramyocardial resistance is minimal and constant. This phase has been shown to be comparable to the maximum hyperemic state of FFR assessment.

The measurement of iFR during the acute phase of STEMI has not yet been evaluated.

AIM: The aim of this study is to assess the reliability of the instantaneous wave-free ratio (iFR) and fractional flow reserve (FFR) measurements in non-culprit coronary lesions during the acute and subacute phase of ST-segment elevation myocardial infarction (STEMI).

METHOD: Patients undergoing primary PCI for STEMI and presenting with multivessel coronary disease (at least one ≥ 50% diameter stenosis in a non-infarct-related coronary artery) were enrolled in a prospective observational registry. Coronary lesions were evaluated with both iFR and FFR immediately after primary PCI (acute phase) and 7 ± 3 days later (subacute phase).

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Conditions studied

  • ST Segment Elevation Myocardial Infarction
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In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's planned enrollment of 60 is below the median of 500 across 983 observational studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

Azienda Ospedaliera San Camillo Forlanini is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients undergoing primary PCI for STEMI and presenting with multivessel coronary disease (at least one ≥ 50% diameter stenosis in a non-infarct-related coronary artery).

Inclusion criteria

  • Patients undergoing primary PCI for STEMI and presenting with multivessel coronary disease (at least one ≥ 50% diameter stenosis in a non-infarct-related coronary artery) were enrolled.

Exclusion criteria

Exclusion Criteria:

  • severe left ventricular dysfunction (Ejection Fraction \<30%).
  • Heart Failure
  • Previous STEMI
  • Severe sinus bradycardia
  • Past medical history of Asthma
  • TIMI flow 1,2
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • FFR and iFR

    The investigators compare FFR and iFR values in the acute phase of STEMI and in the subacute phase, 5-7 days after STEMI.

    Other: FFR and iFR

Interventions

  • OtherFFR and iFR

    The investigators aimed to assess the reliability of the instantaneous wave-free ratio (iFR) and fractional flow reserve (FFR) measurements in non-culprit coronary lesions during the acute and subacute phase of ST-segment elevation myocardial infarction (STEMI).

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What researchers measure

Primary outcomes

  1. Reproducibility of iFR and FFR values in the non culprit lesion during STEMI in the acute and subacute phase.

    Comparison of iFR and FFR values for evaluating the functional significance of non-culprit coronary lesions in patients with STEMI, both during primary PCI and during staged procedures,

    Time frame: 5-7 days

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Study locations

1 of 1 sites recruiting
  • Ospedale San Camillo
    Rome, 00152, Italy
    Recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02869906
Lead sponsor
Azienda Ospedaliera San Camillo Forlanini
Responsible party
Carmine Musto (MD PhD, Azienda Ospedaliera San Camillo Forlanini) — Principal investigator
First posted
Aug 17, 2016
Start date
Sep 2015
Primary completion
Dec 2016 (estimated)
Completion
Dec 2016 (estimated)
Last update
Aug 17, 2016

Study contacts

Carmine Musto, PhD
Contact
cmusto@hotmail.it
+393396361601
Carmine Musto, PhD
principal investigator · Ospedale San Camillo

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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