Angio-based Final Functional Effect of PCI

Acute Coronary Syndrome Clinical Trial

— AFFE-PCI  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06255678
• Other study ID #: AFFE-PCI
• Status: Recruiting
• Start date: July 3, 2023
• Est. completion date: January 1, 2027

Study information

• Verified date: February 2024
• Source: Medical University of Warsaw
• Contact: Mariusz Tomaniak, MD PhD
• Phone: +48 22 5991951
• Email: mariusz.tomaniak[@]wum.edu.pl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2005
• Est. completion date: January 1, 2027
• Est. primary completion date: January 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Chronic Coronary Syndrome
• Non ST Segment Elevation Acute Coronary Syndrome
• Syndrome

Intervention

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)

Locations

Country	Name	City	State
Poland	Medical University of Warsaw	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of MACE defined as all-cause death, target-vessel myocardial infarction (TVMI) and target vessel revascularization (TVR).		24 months
Secondary	Rate of MACE defined as all-cause death, target-vessel myocardial infarction (TVMI) and target vessel revascularization (TVR).		6 months, 12 months
Secondary	Rate of all-cause death		6 months, 12 months, 24 months
Secondary	Rate of target-vessel myocardial infarction (TVMI)		6 months, 12 months, 24 months
Secondary	Rate of target-vessel target vessel revascularization (TVR)		6 months, 12 months, 24 months
Secondary	Symptoms of angina and quality of life assessed by the score of EuroQol 5-level 5-dimensional questionnaire (EQ-5D-5L)	The EQ-5D-5L scale asses the patient's self-rated health in five categories (each category 1-5) - higher values indicate worse performance. Additionally, the patient fulfill vertical visual analog scale from 0 to 100, where higher scores indicate better function.	6 months, 12 months, 24 months
Secondary	Symptoms of angina and quality of life assessed by score of the Seattle Angina Questionnaire (SAQ)	The SAQ provides results for 6 categories. The patient can receive between 0 and 100 points in each category, where 100 represents the best score.	6 months, 12 months, 24 months
Secondary	Correlation of post-percutaneous coronary intervention (PCI) vessel fractional flow reserve (vFFR) with score of Seattle Angina Questionnaire (SAQ).	The SAQ provides results for 6 categories. The patient can receive between 0 and 100 points in each category, where 100 represents the best score. vFFR values are within the range 0-1, where higher values indicate better function.	6 months, 12 months, 24 months
Secondary	Correlation of ?vFFR with score of Seattle Angina Questionnaire (SAQ).	The SAQ provides results for 6 categories. The patient can receive between 0 and 100 points in each category, where 100 represents the best score.	6 months, 12 months, 24 months
Secondary	Correlation of post-percutaneous coronary intervention (PCI) vessel fractional flow reserve (vFFR) with score of EuroQol 5-level 5-dimensional questionnaire (EQ-5D-5L).	The EQ-5D-5L scale asses the patient's self-rated health in five categories (each category 1-5) - higher values indicate worse performance. Additionally, the patient fulfill vertical visual analog scale from 0 to 100, where higher scores indicate better function. vFFR values are within the range 0-1, where higher values indicate better function.	6 months, 12 months, 24 months
Secondary	Correlation of ?vFFR with score of EuroQol 5-level 5-dimensional questionnaire (EQ-5D-5L).	The EQ-5D-5L scale asses the patient's self-rated health in five categories (each category 1-5) - higher values indicate worse performance. Additionally, the patient fulfill vertical visual analog scale from 0 to 100, where higher scores indicate better function.	6 months, 12 months, 24 months
Secondary	AUC for the optimal cutoff point for post-percutaneous coronary intervention (PCI) vessel fractional flow reserve (vFFR) for significant prediction of MACE	MACE defined as all-cause death, target-vessel myocardial infarction (TVMI) and target vessel revascularization (TVR).	6 months, 12 months, 24 months
Secondary	AUC for the optimal cutoff point for ?vFFR useful for prediction of MACE	MACE defined as all-cause death, target-vessel myocardial infarction (TVMI) and target vessel revascularization (TVR).	6 months, 12 months, 24 months
Secondary	AUC for the optimal cutoff point for post-percutaneous coronary intervention (PCI) vessel fractional flow reserve (vFFR) useful for prediction of higher than median SAQ score.	The SAQ provides results for 6 categories. The patient can receive between 0 and 100 points in each category, where 100 represents the best score. vFFR values are within the range 0-1, where higher values indicate better function.	6 months, 12 months, 24 months
Secondary	AUC for the optimal cutoff point for post-percutaneous coronary intervention (PCI) vessel fractional flow reserve (vFFR) useful for prediction of higher than median EQ-5D-5L score.	The scale asses the patient's self-rated health in five categories (each category 1-5) - higher values indicate worse performance. Additionally, the patient fulfill vertical visual analog scale from 0 to 100, where higher scores indicate better function. vFFR values are within the range 0-1, where higher values indicate better function.	6 months, 12 months, 24 months
Secondary	AUC for the optimal cutoff point for ?vFFR useful for prediction of higher than median SAQ score.	The SAQ provides results for 6 categories. The patient can receive between 0 and 100 points in each category, where 100 represents the best score.	6 months, 12 months, 24 months
Secondary	AUC for the optimal cutoff point for ?vFFR useful for prediction of higher than median EQ-5D-5L score.	The scale asses the patient's self-rated health in five categories (each category 1-5) - higher values indicate worse performance. Additionally, the patient fulfill vertical visual analog scale from 0 to 100, where higher scores indicate better function.	6 months, 12 months, 24 months
Secondary	Rate of revascularization of any vessel due to exacerbation of angina symptoms.	Decisions on the performance of revascularization will be made by the attending physician according to the clinical features and available methods.	6 months, 12 months, 24 months
Secondary	Rate of definite and probable stent thrombosis.		6 months, 12 months, 24 months
Secondary	Rate of clinically driven invasive coronary angiography due to exacerbation of angina symptoms.	Decisions on the performance of invasive coronary angiography will be made by the attending physician according to the clinical features.	6 months, 12 months, 24 months
Secondary	AUC for the value of in-stent vFFR gradient in predicting the rate of MACE	vFFR values are within the range 0-1, where higher values indicate better function.	6 months, 12 months, 24 months
Secondary	AUC for the value of 3-vessel post-PCI vFFR burden (sum of the vFFR estimated in the three main epicardial arteries) in predicting the rate of MACE	3-vessel post-PCI vFFR will be defined as the sum of the post-PCI vFFR values derived for each vessel (left anterior descending, circumflex, right coronary artery).	6 months, 12 months, 24 months