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. 2025 Jan 7;46(2):190-214.
doi: 10.1093/eurheartj/ehae724.

Definitions of clinical study outcome measures for cardiovascular diseases: the European Unified Registries for Heart Care Evaluation and Randomized Trials (EuroHeart)

Chris Wilkinson  1   2 , Asad Bhatty  3   4   5 , Gorav Batra  6 , Suleman Aktaa  3   4   5 , Adam B Smith  3   4 , Jeremy Dwight  7 , Marcin Ruciński  7 , Sam Chappell  3   4 , Joakim Alfredsson  8 , David Erlinge  9 , Jorge Ferreira  10 , Ingibjörg J Guðmundsdóttir  11 , Þórdís Jóna Hrafnkelsdóttir  11 , Inga Jóna Ingimarsdóttir  11   12 , Alar Irs  13 , András Jánosi  14 , Zoltán Járai  15 , Manuel Oliveira-Santos  16 , Bogdan A Popescu  17 , Peter Vasko  8 , Dragos Vinereanu  16   18 , Jonathan Yap  19 , Raffaele Bugiardini  20 , Edina Cenko  20 , Ramesh Nadarajah  3   4   5 , Matthew R Sydes  21   22 , Stefan James  6 , Aldo P Maggioni  23 , Lars Wallentin  6 , Barbara Casadei  24 , Chris P Gale  3   4   5 ; Global Cardiovascular Outcomes Consortium and in collaboration with ACNAP, ACVC, EACVI, EAPC, EAPCI, EHRA, ESC Committee for Young CV Professionals, ESC Registry Committee, HFA, ESC Patient Forum and these Working Groups: aorta and peripheral vascular diseases, atherosclerosis and vascular biology, cardiac cellular electrophysiology, cardiovascular pharmacotherapy, cardiovascular regenerative and restorative medicine, cardiovascular surgery, cellular biology of the heart, e-cardiology, myocardial function, pulmonary circulation and right ventricular function and thrombosis
Collaborators, Affiliations

Definitions of clinical study outcome measures for cardiovascular diseases: the European Unified Registries for Heart Care Evaluation and Randomized Trials (EuroHeart)

Chris Wilkinson et al. Eur Heart J. .

Abstract

Background and aims: Standardized definitions for outcome measures in randomized clinical trials and observational studies are essential for robust and valid evaluation of medical products, interventions, care, and outcomes. The European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart) project of the European Society of Cardiology aimed to create international data standards for cardiovascular clinical study outcome measures.

Methods: The EuroHeart methods for data standard development were used. From a Global Cardiovascular Outcomes Consortium of 82 experts, five Working Groups were formed to identify and define key outcome measures for: cardiovascular disease (generic outcomes), acute coronary syndrome and percutaneous coronary intervention (ACS/PCI), atrial fibrillation (AF), heart failure (HF) and transcatheter aortic valve implantation (TAVI). A systematic review of the literature informed a modified Delphi method to reach consensus on a final set of variables. For each variable, the Working Group provided a definition and categorized the variable as mandatory (Level 1) or optional (Level 2) based on its clinical importance and feasibility.

Results: Across the five domains, 24 Level 1 (generic: 5, ACS/PCI: 8, AF: 2; HF: 5, TAVI: 4) and 48 Level 2 (generic: 18, ACS-PCI: 7, AF: 6, HF: 2, TAVI: 15) outcome measures were defined.

Conclusions: Internationally derived and endorsed definitions for outcome measures for a range of common cardiovascular diseases and interventions are presented. These may be used for data alignment to enable high-quality observational and randomized clinical research, audit, and quality improvement for patient benefit.

Keywords: Acute coronary syndrome; Atrial fibrillation; Heart failure; Outcomes; Registry, data, EuroHeart; Transcatheter aortic valve intervention.

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Figures

Structured Graphical Abstract
Structured Graphical Abstract
Internationally derived, standardized definitions for outcome measures in people with cardiovascular disease. ACS-PCI, acute coronary syndrome-percutaneous coronary intervention; HF, heart failure; AF, atrial fibrillation; TAVI, transcatheter aortic valve intervention
Figure 1
Figure 1
Voting results, generic domain. ICD, implantable cardioverter defibrillator. Level 1: mandatory variable; Level 2: optional variable
Figure 2
Figure 2
Voting results, acute coronary syndrome/percutaneous coronary intervention domain. CABG, coronary artery bypass grafting surgery; CCS, Canadian Cardiovascular Society; ICD, implantable cardioverter defibrillator; PCI, percutaneous coronary intervention; RRT, renal replacement therapy; TVR, target vessel revascularisation. Level 1: mandatory variable; Level 2: optional variable
Figure 3
Figure 3
Voting results, AF domain. AF, atrial fibrillation/flutter; PPM, permeant pacemaker; ICD, implantable cardioverter defibrillator; CRT-P, cardiac resynchronisation pacemaker; CRT-D, cardiac resynchronisation defibrillator. Level 1: mandatory variable; Level 2: optional variable
Figure 4
Figure 4
Voting results, heart failure domain. NT-proBNP/BNP, N-Terminal Pro/B-type Natriuretic Peptide; NYHA, New York Heart Association. Level 1: mandatory variable; Level 2: optional variable
Figure 5
Figure 5
Voting results, transcatheter aortic valve intervention domain. CCS, Canadian Cardiac Society; ICD, implantable cardioverter defibrillator; NYHA, New York Heart Association; PPM, permanent pacemaker; TAVI, transcatheter aortic valve intervention. Level 1: mandatory variable; Level 2: optional variable
See this image and copyright information in PMC

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