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Recruiting NCT06255678

Angio-based Final Functional Effect of PCI

— Observational Acute Coronary Syndrome Non ST Segment Elevation Acute Coronary Syndrome Chronic Coronary Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Angiography-based vessel fractional flow reserve (vFFR) calculation.
Who it may be relevant to
Registry conditions: Acute Coronary Syndrome, Non ST Segment Elevation Acute Coronary Syndrome, Chronic Coronary Syndrome. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Angio-based Final Functional Effect of PCI (AFFE PCI): a Prospective Multi-center Study of Post-PCI vFFR Impact on Clinical Outcomes and Residual Angina

Overview

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.

Detailed description

The primary goal of this prospective multicenter register study is to evaluate the association between the value of 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) at 6 and 24 months following PCI. The primary composite endpoint is defined as a major adverse cardiovascular event (MACE) including all-cause death, target-vessel myocardial infarction (TVMI), and target vessel revascularization (TVR)\] at 6, 12 and 24-month follow-ups. Patients undergoing PCI for chronic coronary syndromes (CCS), non-ST-segment elevation acute coronary syndromes (NST-ACS) or or ST-Segment Elevation Myocardial Infarction (STEMI) will be enrolled in this study. The analyses of the primary endpoint will be stratified according to the following subgroups:

* Diabetes/non-diabetes * Glomerular filtration rate (GFR)≥60/GFR\<60 \[ml/min./1,73m2\] * Focal/diffuse atherosclerosis * Multivessel/single-vessel disease * CCS/NST-ACS/STEMI * CCS/ACS

The patients' coronary angiograms will be analyzed using a CAAS workstation (Pie Medical Imaging, Maastricht, the Netherlands) enrolled at the Invasive Cardiology Unit of the 1st Department of Cardiology, Medical University of Warsaw (Poland) and other centers in Poland.

Interventions

  • Diagnostic test Angiography-based vessel fractional flow reserve (vFFR) calculation
    vFFR is calculated from routinely taken angiography images during PCI using a CAAS workstation (Pie Medical Imaging, Maastricht, the Netherlands)

Primary outcome measures

  • Rate of MACE defined as all-cause death, target-vessel myocardial infarction (TVMI) and target vessel revascularization (TVR). [Time frame: 24 months]
Secondary outcome measures (12)
  • Rate of MACE defined as all-cause death, target-vessel myocardial infarction (TVMI) and target vessel revascularization (TVR). [Time frame: 6 months, 12 months]
  • Rate of all-cause death [Time frame: 6 months, 12 months, 24 months]
  • Rate of target-vessel myocardial infarction (TVMI) [Time frame: 6 months, 12 months, 24 months]
  • Rate of target-vessel target vessel revascularization (TVR) [Time frame: 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) [Time frame: 6 months, 12 months, 24 months]
  • Symptoms of angina and quality of life assessed by score of the Seattle Angina Questionnaire (SAQ) [Time frame: 6 months, 12 months, 24 months]
  • Correlation of post-percutaneous coronary intervention (PCI) vessel fractional flow reserve (vFFR) with score of Seattle Angina Questionnaire (SAQ). [Time frame: 6 months, 12 months, 24 months]
  • Correlation of ΔvFFR with score of Seattle Angina Questionnaire (SAQ). [Time frame: 6 months, 12 months, 24 months]
  • Correlation of post-percutaneous coronary intervention (PCI) vessel fractional flow reserve (vFFR) with score of EuroQol 5-level 5-dimensional questionnaire (EQ-5D-5L). [Time frame: 6 months, 12 months, 24 months]
  • Correlation of ΔvFFR with score of EuroQol 5-level 5-dimensional questionnaire (EQ-5D-5L). [Time frame: 6 months, 12 months, 24 months]
  • AUC for the optimal cutoff point for post-percutaneous coronary intervention (PCI) vessel fractional flow reserve (vFFR) for significant prediction of MACE [Time frame: 6 months, 12 months, 24 months]
  • AUC for the optimal cutoff point for ΔvFFR useful for prediction of MACE [Time frame: 6 months, 12 months, 24 months]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Poland · 1 center
  • Medical University of Warsaw — Warsaw

Publications

  • Tomaniak M, Sadowski K, Bednarek A, Huczek Z, Gierlotka M, Hawranek M, Grabowski M, Wojakowski W, Milewski K, Kochman J. 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. Cardiol J. 2024;31(3):488-495. doi: 10.5603/cj.99332. Epub 2024 May 2. No abstract av PMID 38695286

Identifiers

NCT: NCT06255678 · AFFE-PCI

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗