Instantaneous Wave-Free Ratio and Fractional Flow Reserve for the Assessment of Non Culprit Lesions in Patients With ST-segment Elevation Myocardial Infarction
WAVE
1 other identifier
observational
60
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 9, 2016
CompletedFirst Posted
Study publicly available on registry
August 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedAugust 17, 2016
August 1, 2016
1.3 years
August 9, 2016
August 16, 2016
Conditions
Outcome Measures
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,
5-7 days
Study Arms (1)
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.
Interventions
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).
Eligibility 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).
You may qualify if:
- 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.
You may not qualify if:
- severe left ventricular dysfunction (Ejection Fraction \<30%).
- Heart Failure
- Previous STEMI
- Severe sinus bradycardia
- Past medical history of Asthma
- TIMI flow 1,2
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ospedale San Camillo
Rome, 00152, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carmine Musto, PhD
Ospedale San Camillo
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD
Study Record Dates
First Submitted
August 9, 2016
First Posted
August 17, 2016
Study Start
September 1, 2015
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
August 17, 2016
Record last verified: 2016-08