Daan Ties1, Paulien van Dorp2, Gabija Pundziute2, Carlijn M van der Aalst3, Jan Willem C Gratama4, Richard L Braam5, Dirkjan Kuijpers6, Daniël D Lubbers7, Ivo A C van der Bilt8, B Daan Westenbrink2, Martijn J Oude Wolcherink9, Carine J M Doggen9, Ivana Išgum10, Robin Nijveldt11, Harry J de Koning3, Rozemarijn Vliegenthart12, Matthijs Oudkerk13, Pim van der Harst14. 1. Department of Cardiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands. Electronic address: d.ties@umcg.nl. 2. Department of Cardiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands. 3. Department of Public Health, Erasmus Medical Center, Rotterdam, The Netherlands. 4. Department of Radiology and Nuclear Medicine, Gelre Ziekenhuizen, Apeldoorn, The Netherlands. 5. Department of Cardiology, Gelre Ziekenhuizen, Apeldoorn, The Netherlands. 6. Department of Radiology, Haaglanden Medical Center, The Hague, The Netherlands. 7. Department of Radiology, Nij Smellinghe Ziekenhuis, Drachten, The Netherlands. 8. Department of Cardiology, Haga Teaching Hospital, The Hague, The Netherlands. 9. Department of Health Technology and Services Research, Faculty BMS, Technical Medical Center, University of Twente, Enschede, The Netherlands. 10. Department of Biomedical Engineering and Physics, Cardiovascular Institute, Department of Radiology and Nuclear Medicine, Amsterdam Medical Center, Amsterdam, The Netherlands. 11. Department of Cardiology, Radboud University, Radboud University Medical Center, Nijmegen, The Netherlands. 12. Department of Radiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands. 13. Institute for Diagnostic Accuracy, University of Groningen, Groningen, Netherlands. 14. Department of Cardiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands; Department of Cardiology, Division of Heart & Lungs, Utrecht University, Utrecht University Medical Center, Utrecht, The Netherlands. Electronic address: p.vanderharst@umcutrecht.nl.
Abstract
BACKGROUND: Coronary artery disease (CAD) burden for society is expected to steeply increase over the next decade. Improved feasibility and efficiency of preventive strategies is necessary to flatten the curve. Acute myocardial infarction (AMI) is the main determinant of CAD-related mortality and morbidity, and predominantly occurs in individuals with more advanced stages of CAD causing subclinical myocardial ischemia (obstructive CAD; OCAD). Unfortunately, OCAD can remain subclinical until its destructive presentation with AMI or sudden death. Current primary preventive strategies are not designed to differentiate between non-OCAD and OCAD and the opportunity is missed to treat individuals with OCAD more aggressively. METHODS: EARLY-SYNERGY is a multicenter, randomized-controlled clinical trial in individuals with coronary artery calcium (CAC) presence to study (1.) the yield of cardiac magnetic resonance stress myocardial perfusion imaging (CMR-MPI) for early OCAD diagnosis and (2) whether early OCAD diagnosis improves outcomes. Individuals with CAC score ≥300 objectified in 2 population-based trials (ROBINSCA; ImaLife) are recruited for study participation. Eligible candidates are randomized 1:1 to cardiac magnetic resonance stress myocardial perfusion imaging (CMR-MPI) or no additional functional imaging. In the CMR-MPI arm, feedback on imaging results is provided to primary care provider and participant in case of guideline-based actionable findings. Participants are followed-up for clinical events, healthcare utilization and quality of life. CONCLUSIONS: EARLY-SYNERGY is the first randomized-controlled clinical trial designed to test the hypothesis that subclinical OCAD is widely present in the general at-risk population and that early differentiation of OCAD from non-OCAD followed by guideline-recommended treatment improves outcomes.
BACKGROUND: Coronary artery disease (CAD) burden for society is expected to steeply increase over the next decade. Improved feasibility and efficiency of preventive strategies is necessary to flatten the curve. Acute myocardial infarction (AMI) is the main determinant of CAD-related mortality and morbidity, and predominantly occurs in individuals with more advanced stages of CAD causing subclinical myocardial ischemia (obstructive CAD; OCAD). Unfortunately, OCAD can remain subclinical until its destructive presentation with AMI or sudden death. Current primary preventive strategies are not designed to differentiate between non-OCAD and OCAD and the opportunity is missed to treat individuals with OCAD more aggressively. METHODS: EARLY-SYNERGY is a multicenter, randomized-controlled clinical trial in individuals with coronary artery calcium (CAC) presence to study (1.) the yield of cardiac magnetic resonance stress myocardial perfusion imaging (CMR-MPI) for early OCAD diagnosis and (2) whether early OCAD diagnosis improves outcomes. Individuals with CAC score ≥300 objectified in 2 population-based trials (ROBINSCA; ImaLife) are recruited for study participation. Eligible candidates are randomized 1:1 to cardiac magnetic resonance stress myocardial perfusion imaging (CMR-MPI) or no additional functional imaging. In the CMR-MPI arm, feedback on imaging results is provided to primary care provider and participant in case of guideline-based actionable findings. Participants are followed-up for clinical events, healthcare utilization and quality of life. CONCLUSIONS: EARLY-SYNERGY is the first randomized-controlled clinical trial designed to test the hypothesis that subclinical OCAD is widely present in the general at-risk population and that early differentiation of OCAD from non-OCAD followed by guideline-recommended treatment improves outcomes.
Authors: Daan Ties; Paulien van Dorp; Gabija Pundziute; Erik Lipsic; Carlijn M van der Aalst; Matthijs Oudkerk; Harry J de Koning; Rozemarijn Vliegenthart; Pim van der Harst Journal: J Clin Med Date: 2022-05-24 Impact factor: 4.964