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

ST Segment Elevation Myocardial Infarction Clinical Trial

— WAVE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02869906
• Other study ID #: 1510/2016 CE Lazio 1
• Status: Recruiting
• Phase: N/A
• First received: August 9, 2016
• Last updated: August 16, 2016
• Start date: September 2015
• Est. completion date: December 2016

Study information

• Verified date: August 2016
• Source: Azienda Ospedaliera San Camillo Forlanini
• Contact: Carmine Musto, PhD
• Phone: +393396361601
• Email: cmusto[@]hotmail.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Segment Elevation Myocardial Infarction

Intervention

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).

Locations

Country	Name	City	State
Italy	Ospedale San Camillo	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera San Camillo Forlanini

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No