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

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).

Study Overview

• Status: Unknown
• Conditions: ST Segment Elevation Myocardial Infarction
• Intervention / Treatment: Other: FFR and iFR

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).

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Carmine Musto, PhD; Phone Number: +393396361601; Email: cmusto@hotmail.it

Study Locations

• Italy
  • Rome, Italy, 00152
    • Recruiting
    • Ospedale San Camillo
    • Contact: Carmine Musto, PhD; Phone Number: +393396361601; Email: cmusto@hotmail.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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,	5-7 days

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera San Camillo Forlanini
• Investigators: Principal Investigator: Carmine Musto, PhD, Ospedale San Camillo

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: August 9, 2016
• First Submitted That Met QC Criteria: August 16, 2016
• First Posted (Estimate): August 17, 2016

Study Record Updates

• Last Update Posted (Estimate): August 17, 2016
• Last Update Submitted That Met QC Criteria: August 16, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction
• Other Study ID Numbers: 1510/2016 CE Lazio 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided