iFR-guided Revascularization in STEMI
WAVE
iFR-guided Revascularization of Non-culprit Lesion in Patients With ST-segment Elevation Myocardial Infarction and Multivessel Disease (WAVE Registry): Long-term Outcome.
1 other identifier
observational
200
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 long-term prognosis. It was previously demonstrated the diagnostic accuracy of instantaneous wave-free ratio (iFR) in functional assessment of non-culprit lesions in multivessel patients with ST-segment elevation myocardial infarction (STEMI), also highlighting the intralesional reproducibility of both fractional flow reserve (FFR) and iFR between baseline and staged. In this study the investigators aimed to verify the clinical impact on long-term outcome of iFR assessment in the acute multivessel setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2018
CompletedFirst Submitted
Initial submission to the registry
May 27, 2018
CompletedFirst Posted
Study publicly available on registry
June 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2020
CompletedJanuary 18, 2020
January 1, 2020
1.9 years
May 27, 2018
January 15, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Target Lesion Failure (TLF)
A composite of cardiovascular death, non-fatal myocardial infarction, and ischemia-driven revascularization of the vessel previously assessed with iFR
12 months
Eligibility Criteria
Patients undergoing primary PCI for STEMI and presenting with multi vessel coronary disease (at least one ≥ 50% diameter stenosis in a non-infarct-related coronary artery).
You may qualify if:
- age\> 18 years
- hour chest pain with ST segment elevation greater than 0.1 mV in at least two contiguous leads treated with primary PCI
- presence of at least one non-culprit lesion with ≥50% stenosis in an epicardial vessel ≥2.5 mm
- informed consent signed
You may not qualify if:
- ejection fraction ≤ 30%
- presence of moderate / severe valvulopathies
- electrical instability and hemodynamics at the end of the index procedure (Killip III-IV class)
- TIMI flow \<3 at the end of the index procedure
- previous myocardial infarction in the same territory of the non-culprit lesion
- previous coronary artery bypass grafting on the vessel undergoing functional assessment by iFR
- Inability to provide informed consent to the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ospedale San Camillo
Roma, 00152, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Carmine Musto, MD, Principal Investigator, Interventional Cardiology Unit
Study Record Dates
First Submitted
May 27, 2018
First Posted
June 19, 2018
Study Start
May 1, 2018
Primary Completion
March 31, 2020
Study Completion
March 31, 2020
Last Updated
January 18, 2020
Record last verified: 2020-01