Early detection of obstructive coronary artery disease in the asymptomatic high-risk population: objectives and study design of the EARLY-SYNERGY trial

Daan Ties; Paulien van Dorp; Gabija Pundziute; Carlijn M. van der Aalst; Jan Willem C. Gratama; Richard L. Braam; Dirkjan Kuijpers; Daniël D. Lubbers; Ivo A.C. van der Bilt; B. Daan Westenbrink; Martijn J.Oude Wolcherink; Carine J.M. Doggen; Ivana Išgum; Robin Nijveldt; Harry J. de Koning; Rozemarijn Vliegenthart; Matthijs Oudkerk; Pim van der Harst

doi:10.1016/j.ahj.2022.01.005

Early detection of obstructive coronary artery disease in the asymptomatic high-risk population: objectives and study design of the EARLY-SYNERGY trial

Daan Ties^*, Paulien van Dorp, Gabija Pundziute, Carlijn M. van der Aalst, Jan Willem C. Gratama, Richard L. Braam, Dirkjan Kuijpers, Daniël D. Lubbers, Ivo A.C. van der Bilt, B. Daan Westenbrink, Martijn J.Oude Wolcherink, Carine J.M. Doggen, Ivana Išgum, Robin Nijveldt, Harry J. de Koning, Rozemarijn Vliegenthart, Matthijs Oudkerk, Pim van der Harst

^*Corresponding author for this work

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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.

Original language	English
Pages (from-to)	166-177
Number of pages	12
Journal	American Heart Journal
Volume	246
DOIs	https://doi.org/10.1016/j.ahj.2022.01.005
Publication status	Published - Apr 2022

Bibliographical note

Acknowledgements:
This research was supported by the Dutch Heart Foundation (EARLY-SYNERGY – research grant CVON2015-17) and Siemens Healthineers (PUSH – partnership IPA No.11 PUSH MRA). The Lifelines Biobank initiative has been made possible by funding by FES (Fonds Economische Structuurversterking), SNN (Samenwerkingsverband Noord Nederland) and REP (Ruimtelijk Economisch Programma). The ImaLife study is supported by an institutional research grant from Siemens Healthineers and by the Ministry of Economic Affairs and Climate Policy by means of the PPP Allowance made available by the Top Sector Life Sciences & Health to stimulate public-private partnerships. The ROBINSCA trial has been made possible by funding by the EU (ROBINSCA – Advanced research grant: grantnumber 294604). The authors wish to acknowledge the services of the Lifelines Cohort Study, the contributing research centers delivering data to Lifelines, and all the study participants. The authors are grateful to all the imaging technicians and supporting personnel at the local hospitals for their contribution to conducting the study.

Publisher Copyright: © 2022 The Authors

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Ties, D., van Dorp, P., Pundziute, G., van der Aalst, C. M., Gratama, J. W. C., Braam, R. L., Kuijpers, D., Lubbers, D. D., van der Bilt, I. A. C., Westenbrink, B. D., Wolcherink, M. J. O., Doggen, C. J. M., Išgum, I., Nijveldt, R., de Koning, H. J., Vliegenthart, R., Oudkerk, M., & van der Harst, P. (2022). Early detection of obstructive coronary artery disease in the asymptomatic high-risk population: objectives and study design of the EARLY-SYNERGY trial. American Heart Journal, 246, 166-177. https://doi.org/10.1016/j.ahj.2022.01.005

@article{7b4354701c9b4706aa4dbf013514bcb6,

title = "Early detection of obstructive coronary artery disease in the asymptomatic high-risk population: objectives and study design of the EARLY-SYNERGY trial",

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.",

author = "Daan Ties and {van Dorp}, Paulien and Gabija Pundziute and {van der Aalst}, {Carlijn M.} and Gratama, {Jan Willem C.} and Braam, {Richard L.} and Dirkjan Kuijpers and Lubbers, {Dani{\"e}l D.} and {van der Bilt}, {Ivo A.C.} and Westenbrink, {B. Daan} and Wolcherink, {Martijn J.Oude} and Doggen, {Carine J.M.} and Ivana I{\v s}gum and Robin Nijveldt and {de Koning}, {Harry J.} and Rozemarijn Vliegenthart and Matthijs Oudkerk and {van der Harst}, Pim",

note = "Acknowledgements: This research was supported by the Dutch Heart Foundation (EARLY-SYNERGY – research grant CVON2015-17) and Siemens Healthineers (PUSH – partnership IPA No.11 PUSH MRA). The Lifelines Biobank initiative has been made possible by funding by FES (Fonds Economische Structuurversterking), SNN (Samenwerkingsverband Noord Nederland) and REP (Ruimtelijk Economisch Programma). The ImaLife study is supported by an institutional research grant from Siemens Healthineers and by the Ministry of Economic Affairs and Climate Policy by means of the PPP Allowance made available by the Top Sector Life Sciences & Health to stimulate public-private partnerships. The ROBINSCA trial has been made possible by funding by the EU (ROBINSCA – Advanced research grant: grantnumber 294604). The authors wish to acknowledge the services of the Lifelines Cohort Study, the contributing research centers delivering data to Lifelines, and all the study participants. The authors are grateful to all the imaging technicians and supporting personnel at the local hospitals for their contribution to conducting the study. Publisher Copyright: {\textcopyright} 2022 The Authors",

year = "2022",

month = apr,

doi = "10.1016/j.ahj.2022.01.005",

language = "English",

volume = "246",

pages = "166--177",

journal = "American Heart Journal",

issn = "0002-8703",

publisher = "Mosby Inc.",

}

Ties, D, van Dorp, P, Pundziute, G, van der Aalst, CM, Gratama, JWC, Braam, RL, Kuijpers, D, Lubbers, DD, van der Bilt, IAC, Westenbrink, BD, Wolcherink, MJO, Doggen, CJM, Išgum, I, Nijveldt, R, de Koning, HJ, Vliegenthart, R, Oudkerk, M & van der Harst, P 2022, 'Early detection of obstructive coronary artery disease in the asymptomatic high-risk population: objectives and study design of the EARLY-SYNERGY trial', American Heart Journal, vol. 246, pp. 166-177. https://doi.org/10.1016/j.ahj.2022.01.005

TY - JOUR

T1 - Early detection of obstructive coronary artery disease in the asymptomatic high-risk population

T2 - objectives and study design of the EARLY-SYNERGY trial

AU - Ties, Daan

AU - van Dorp, Paulien

AU - Pundziute, Gabija

AU - van der Aalst, Carlijn M.

AU - Gratama, Jan Willem C.

AU - Braam, Richard L.

AU - Kuijpers, Dirkjan

AU - Lubbers, Daniël D.

AU - van der Bilt, Ivo A.C.

AU - Westenbrink, B. Daan

AU - Wolcherink, Martijn J.Oude

AU - Doggen, Carine J.M.

AU - Išgum, Ivana

AU - Nijveldt, Robin

AU - de Koning, Harry J.

AU - Vliegenthart, Rozemarijn

AU - Oudkerk, Matthijs

AU - van der Harst, Pim

N1 - Acknowledgements: This research was supported by the Dutch Heart Foundation (EARLY-SYNERGY – research grant CVON2015-17) and Siemens Healthineers (PUSH – partnership IPA No.11 PUSH MRA). The Lifelines Biobank initiative has been made possible by funding by FES (Fonds Economische Structuurversterking), SNN (Samenwerkingsverband Noord Nederland) and REP (Ruimtelijk Economisch Programma). The ImaLife study is supported by an institutional research grant from Siemens Healthineers and by the Ministry of Economic Affairs and Climate Policy by means of the PPP Allowance made available by the Top Sector Life Sciences & Health to stimulate public-private partnerships. The ROBINSCA trial has been made possible by funding by the EU (ROBINSCA – Advanced research grant: grantnumber 294604). The authors wish to acknowledge the services of the Lifelines Cohort Study, the contributing research centers delivering data to Lifelines, and all the study participants. The authors are grateful to all the imaging technicians and supporting personnel at the local hospitals for their contribution to conducting the study. Publisher Copyright: © 2022 The Authors

PY - 2022/4

Y1 - 2022/4

N2 - 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.

AB - 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.

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AN - SCOPUS:85124467191

SN - 0002-8703

VL - 246

SP - 166

EP - 177

JO - American Heart Journal

JF - American Heart Journal

ER -

Early detection of obstructive coronary artery disease in the asymptomatic high-risk population: objectives and study design of the EARLY-SYNERGY trial

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