Study of Angiography-Based Vessel Fractional Flow Reserve After PCI
Assessing Impact on Clinical Outcomes and Angina in Coronary Syndrome Patients
Led by Medical University of Warsaw · Updated on 2024-02-13
2005
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying patients with coronary artery disease undergoing percutaneous coronary intervention PCI to better understand the value of angiography-based vessel fractional flow reserve vFFR and its change u0394vFFR after PCI. This study focuses on how these measures relate to major adverse cardiovascular events MACE, residual angina, and quality of life in people with chronic coronary syndromes, non-ST-segment elevation acute coronary syndromes, or ST-segment elevation myocardial infarction. It is a prospective multicenter observational study led by the Medical University of Warsaw.
The study uses angiography images taken during PCI to calculate vFFR with specialized software. Patients undergoing PCI will be followed over time, with assessments at 6, 12, and 24 months after the procedure. The research will analyze the association of post-PCI vFFR and u0394vFFR values with clinical outcomes, angina symptoms, and quality of life scores from the Seattle Angina Questionnaire SAQ and EuroQol 5-level 5-dimensional questionnaire EQ-5D-5L. Various patient subgroups will also be evaluated.
Participants will have their coronary angiograms analyzed using a CAAS workstation. Researchers will collect data on adverse cardiovascular events such as death, myocardial infarction, and repeat vessel revascularization, along with patients angina symptoms and quality of life at several time points during the 2-year follow-up. The study aims to improve understanding of how post-PCI functional measures relate to patient health and outcomes over time.
CONDITIONS
Brief Title
Angio-based Final Functional Effect of PCI
Research Team
M
Mariusz Tomaniak, MD PhD
K
Karol Sadowski
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Provided written informed consent before the procedure
You will not qualify if you...
Cardiogenic shock or pulmonary oedema
Severe hemodynamic instability
Prior coronary artery bypass grafting (CABG)
Active bleeding
Acute or chronic inflammatory conditions
Acute mechanical complications of myocardial infarction
Congenital heart disease
Heart transplantation
Non-cardiac illnesses with life expectancy less than 1 year
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) prior to PCI
Diagnostic Evaluation
Duration - Day of PCI
Participants undergo PCI during which angiography images are routinely taken to calculate vessel fractional flow reserve (vFFR) using a CAAS workstation.
1 visit (in-person) during PCI procedure
Long-term Monitoring
Duration - 24 months
Participants are followed for clinical outcomes, residual angina symptoms, and quality of life assessed at multiple timepoints after PCI.
Follow-up visits at 6 months, 12 months, and 24 months
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Study design and rationale of the angio-based final functional effect of PCI (AFFE PCI) study: a prospective multi-center study of post-PCI vFFR impact on clinical outcomes and residual angina.
Mariusz Tomaniak, Karol Sadowski, Adrian Bednarek...