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OpenTrials
Completed

NCT Number: NCT05592535

Outcomes With Fractional Flow Reserve in Chronic Coronary Syndrome

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

About this study

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]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coronary revascularization

Procedure

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

Primary outcomes

  1. Risk difference (%) for the composite of all-cause death and FFR-oriented target vessel revascularization by PCI

    Time frame: Up to one year following index FFR measurement

Secondary outcomes

  1. Risk difference (%) for the composite of all-cause death, FFR-oriented target vessel revascularization by PCI and hospitalization for acute myocardial infarction

    Time frame: Up to one year following index FFR measurement

  2. Risk difference (%) for the composite of all-cause death and new hospitalization for acute myocardial infarction

    Time frame: Up to one year following index FFR measurement

  3. Risk differences (%) for the individual components of the composite outcome measures

    Time frame: Up to one year following index FFR measurement

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Official study title

Prognostic Impact of Fractional Flow Reserve in Chronic Coronary Syndrome: Quasi-Experimental Findings Using a Regression Discontinuity Design

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Oct 24, 2022
Registry last updated
Oct 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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