Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05592535
Other study ID # 1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2015
Est. completion date June 1, 2020

Study information

Verified date October 2022
Source Uppsala University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The use of fractional flow reserve (FFR) to assess the functional relevance of coronary stenoses has been demonstrated to reduce the risk urgent revascularization in chronic coronary syndrome patients.[1] The goal of this study is to assess whether the utility of using FFR during percutaneous coronary intervention (PCI) in chronic coronary syndrome patients is confirmed in a real-life scenario. This study will implement a regression discontinuity design (RDD). RDD is a quasi-experimental study design able to provide robust findings on causality using observational data.


Description:

All patients in this study were included in the Swedish Coronary Angiography and Angioplasty Registry (SCAAR), a sub-registry of SWEDEHEART. [2] Data regarding FFR assessments are documented in SCAAR in terms of FFR values and coronary segments investigated with FFR. The use of FFR during PCI is left at the discretion of the operator. Since a nondeterministic assignment to revascularization is expected at the cut-off, a fuzzy RDD design will be used in the analyses. Moreover, FFR values equal to 0.80 (at the cut-off) will be excluded from the analysis since treatment assignment exactly at the cut-off may substantially vary across operators and this may create distortions in the treatment discontinuity. Local linear regression estimates with Kernel triangulation and asymmetric bandwidth selection will be used in the analysis. Bandwidth selection will be based on a fully data-driven approach that minimizes the bias-variance trade-off.[3] Estimates from RDD will be presented as risk differences [RD] complemented by 95% robust confidence intervals.[4]


Recruitment information / eligibility

Status Completed
Enrollment 5000
Est. completion date June 1, 2020
Est. primary completion date June 1, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Chronic coronary syndrome undergoing coronary angiography and FFR measurement - Swedish personal identification number Exclusion Criteria: - previous coronary artery bypass grafting - left main disease or undergoing FFR/PCI of left main - IVUS/OCT use - diffuse disease (= 2 segments treated in a same vessel investigated with FFR, = 2 segments investigated with FFR in a same vessel) - PCI in a distal segment with respect to FFR measurements

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Coronary revascularization
Coronary revascularization performed by PCI in a vessel investigated with FFR or indication for surgery

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Uppsala University

References & Publications (4)

Calonico S, Cattaneo MD, Farrell MH. Optimal bandwidth choice for robust bias corrected inference in regression discontinuity designs. Econom J. 2020;23(2):192-210.

Calonico S, Cattaneo MD, Titiunik R. Robust nonparametric confidence intervals for regression-discontinuity designs. Econometrica. 2014;82(6):2295-2326.

De Bruyne B, Pijls NH, Kalesan B, Barbato E, Tonino PA, Piroth Z, Jagic N, Möbius-Winkler S, Rioufol G, Witt N, Kala P, MacCarthy P, Engström T, Oldroyd KG, Mavromatis K, Manoharan G, Verlee P, Frobert O, Curzen N, Johnson JB, Jüni P, Fearon WF; FAME 2 Trial Investigators. Fractional flow reserve-guided PCI versus medical therapy in stable coronary disease. N Engl J Med. 2012 Sep 13;367(11):991-1001. doi: 10.1056/NEJMoa1205361. Epub 2012 Aug 27. Erratum in: N Engl J Med. 2012 Nov;367(18):1768. Mobius-Winckler, Sven [corrected to Möbius-Winkler, Sven]. — View Citation

Jernberg T, Attebring MF, Hambraeus K, Ivert T, James S, Jeppsson A, Lagerqvist B, Lindahl B, Stenestrand U, Wallentin L. The Swedish Web-system for enhancement and development of evidence-based care in heart disease evaluated according to recommended therapies (SWEDEHEART). Heart. 2010 Oct;96(20):1617-21. doi: 10.1136/hrt.2010.198804. Epub 2010 Aug 27. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Risk difference (%) for the composite of all-cause death and FFR-oriented target vessel revascularization by PCI Up to one year following index FFR measurement
Secondary Risk difference (%) for the composite of all-cause death, FFR-oriented target vessel revascularization by PCI and hospitalization for acute myocardial infarction Up to one year following index FFR measurement
Secondary Risk difference (%) for the composite of all-cause death and new hospitalization for acute myocardial infarction Up to one year following index FFR measurement
Secondary Risk differences (%) for the individual components of the composite outcome measures Up to one year following index FFR measurement
See also
  Status Clinical Trial Phase
Recruiting NCT06185530 - SECURE Trial: Stress Echocardiography With Carotid Ultrasound vs Routine CT Coronary Angiography in Chronic Coronary Syndrome for Endpoints N/A
Recruiting NCT05117866 - Acetyl Salicylic Elimination Trial JAPAN: The ASET JAPAN Pilot Study N/A
Recruiting NCT05727982 - Identification of Molecular Mechanisms of Coronary Instability in Homogeneous Subsets of Patients With Acute Coronary Syndromes for the Implementation of Precision Medicine
Completed NCT06464276 - Effectiveness and Tolerability of Trimetazidine 80mg Once Daily in Patients With Chronic Coronary Syndrome: The V-GOOD Study
Recruiting NCT03936504 - Efficacy and Mechanism of TCCRP in Patients With Chronic Coronary Syndrome Under Fusion Cardiac Rehabilitation Model N/A
Recruiting NCT05978089 - Effect of Yangxinshi Tablet on Exercise Tolerance in Patients With Chronic Coronary Syndrome(MET STUDY) Phase 4
Recruiting NCT05875311 - Telemonitoring System for Improving Continuity of Care in Patients With Chronic Coronary Syndrome (TELSINCORC) N/A
Recruiting NCT05865600 - Perfusion Estimation For Optimal Treatment Strategy in Chronic Coronary Syndrome N/A
Recruiting NCT06337461 - Computational mOdelliNg of myoCardial pERfusion to Improve ouTcome Prediction Based on cOronary Artery Stenosis and Atherosclerotic Plaque Burden Assessment by Computed Tomography
Recruiting NCT05640752 - Optimal Evaluation to Reduce Imaging Testing N/A
Recruiting NCT05635994 - Advanced Invasive Diagnosis for Patients With Chronic Coronary Syndromes Undergoing Coronary ANGIOgraphy (AID-ANGIO)
Recruiting NCT05583786 - Intracoronary ECG ST-segment Shift Remission Time During Reactive Coronary Hyperemia
Recruiting NCT06255678 - Angio-based Final Functional Effect of PCI
Recruiting NCT06275399 - Comprehensive Assessment of Morphometric, Functional, Biomechanical and Biological Interactions Between Atherosclerotic Plaque and Platelets Within the Stenosed Coronary Artery
Not yet recruiting NCT06186336 - Feasibility of a Deep Learning-based Algorithm for Non-invasive Assessment of Vulnerable Coronary Plaque
Withdrawn NCT04738344 - Very Long Versus Overlapping Stents in Long Coronary Lesions N/A
Active, not recruiting NCT04135989 - Personalized Vs. Standard Duration of Dual Antiplatelet Therapy and New-generation Polymer-Free vs- Biodegradable-Polymer DES Phase 4
Recruiting NCT05674630 - Ticin for the Treatment of Coronary Lesions With Drug Eluting Ballons Phase 4
Recruiting NCT06171061 - Yangxinshi Tablet Intervention for Exercise Capacity in Patients With Chronic Coronary Syndrome Phase 4
Recruiting NCT05379608 - Intermittent Hypoxic-hyperoxic Training in Patients With Cardiovascular Pathology After COVID-19 Infection. N/A