Angio-based Final Functional Effect of PCI
AFFE-PCI
1 other identifier
observational
2,005
1 country
1
Brief Summary
Fractional flow reserve (FFR) has revolutionized the diagnosis and treatment of coronary artery disease (CAD), and more recently, post percutaneous coronary intervention (post-PCI) FFR has emerged as an independent predictor of cardiovascular events, enabling the identification of cases requiring additional optimization of the implanted stent. Modern technologies allow less invasive alternatives to traditional FFR measurement - angiography-based vessel fractional flow reserve (vFFR) and derivative ΔvFFR, which is calculated by a difference between the post-PCI vFFR and pre-PCI vFFR. In large clinical studies, the good accuracy between vFFR and FFR - measured before and after PCI - has been confirmed. However, insufficient data is available about the value of post-vFFR and ΔvFFR as prognostic values and indicators of patient health. This is a prospective multicenter register study analyzing the association between the value of ΔvFFR, vFFR after PCI and adverse clinical outcomes, residual angina and quality of life using the validated Seattle Angina Questionnaire (SAQ) and EuroQol 5-level 5-dimensional questionnaire (EQ-5D-5L). Patients undergoing PCI for chronic coronary syndromes (CCS), non-ST-segment elevation acute coronary syndromes (NST-ACS) or ST-Segment Elevation Myocardial Infarction (STEMI) will be enrolled in this study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2023
Typical duration for all trials
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
July 3, 2023
CompletedFirst Submitted
Initial submission to the registry
January 16, 2024
CompletedFirst Posted
Study publicly available on registry
February 13, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
February 13, 2024
February 1, 2024
3.5 years
January 16, 2024
February 2, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of MACE defined as all-cause death, target-vessel myocardial infarction (TVMI) and target vessel revascularization (TVR).
24 months
Secondary Outcomes (21)
Rate of MACE defined as all-cause death, target-vessel myocardial infarction (TVMI) and target vessel revascularization (TVR).
6 months, 12 months
Rate of all-cause death
6 months, 12 months, 24 months
Rate of target-vessel myocardial infarction (TVMI)
6 months, 12 months, 24 months
Rate of target-vessel target vessel revascularization (TVR)
6 months, 12 months, 24 months
Symptoms of angina and quality of life assessed by the score of EuroQol 5-level 5-dimensional questionnaire (EQ-5D-5L)
6 months, 12 months, 24 months
- +16 more secondary outcomes
Study Arms (1)
Patients undergoing PCI
Assessment of ΔvFFR and vFFR after PCI and adverse clinical outcomes, residual angina and quality of life using the validated Seattle Angina Questionnaire (SAQ) and EuroQol 5-level 5-dimensional questionnaire (EQ-5D-5L) in patients with CCS or ACS.
Interventions
vFFR is calculated from routinely taken angiography images during PCI using a CAAS workstation (Pie Medical Imaging, Maastricht, the Netherlands)
Eligibility Criteria
Patients with percutaneous coronary intervention (PCI) for chronic coronary syndromes (CCS) or acute coronary syndromes (ACS)
You may qualify if:
- Percutaneous coronary intervention (PCI) for chronic coronary syndromes (CCS) or acute coronary syndromes (ACS)
- Adequate quality of angiogram enabling vFFR analysis (available two angiographic views with ≥30° differences in rotation/angulation, the possibility of vessel contour selection, proper quality of the images, vessels without severe overlapping, tortuosity, foreshortening and poor vessel opacification)
- Age \>18 years
- The patient's written informed consent has been obtained before the procedure
You may not qualify if:
- Cardiogenic shock, pulmonary oedema
- Severe hemodynamical instability
- Prior coronary artery bypass grafting (CABG)
- Active bleeding
- Acute and chronic inflammatory conditions
- Acute mechanical complications of myocardial infarction
- Congenital heart disease
- Heart transplantation
- Non-cardiac comorbidities with a life expectancy of less than 1 year
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of Warsaw
Warsaw, 02-097, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Tomaniak Mariusz MD PhD Assoc. Prof.
Study Record Dates
First Submitted
January 16, 2024
First Posted
February 13, 2024
Study Start
July 3, 2023
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Last Updated
February 13, 2024
Record last verified: 2024-02