Actively Recruiting
Led by Medical University of Warsaw · Updated on 2024-02-13
2005
Participants Needed
1
Research Sites
N/A
Total Duration
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
Angio-based Final Functional Effect of PCI
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) prior to PCI
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
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
Total: 1 location
1
Medical University of Warsaw
Warsaw, Poland, 02-097
Actively Recruiting
M
Mariusz Tomaniak, MD PhD
K
Karol Sadowski
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Mariusz Tomaniak, Karol Sadowski, Adrian Bednarek...
https://pubmed.ncbi.nlm.nih.gov/38695286