TY - JOUR
T1 - Cardiovascular imaging of women and men visiting the outpatient clinic with chest pain or discomfort
T2 - design and rationale of the ARGUS Study
AU - Groepenhoff, Floor
AU - Eikendal, Anouk L M
AU - Bots, Sophie Heleen
AU - van Ommen, Anne-Mar
AU - Overmars, L M
AU - Kapteijn, Daniek
AU - Pasterkamp, Gerard
AU - Reiber, Johan H C
AU - Hautemann, David
AU - Menken, Roxana
AU - Wittekoek, Marianne E
AU - Hofstra, Leonard
AU - Onland-Moret, N Charlotte
AU - Haitjema, Saskia
AU - Hoefer, Imo
AU - Leiner, Tim
AU - den Ruijter, Hester M
N1 - Funding Information:
Funding The original investigator-initiated project HELPFul received funding from the Dutch Heart Foundation 2013T084 (Queen of Hearts). The current ARGUS Study using CMRI and CCTA is supported by funding from CVON 2017-22 ARGUS.
Funding Information:
The original investigator-initiated project HELPFul received funding from the Dutch Heart Foundation 2013T084 (Queen of Hearts). The current ARGUS Study using CMRI and CCTA is supported by funding from CVON 2017-22 ARGUS. We sincerely thank Ms Jonne Emanuel-Hos and Gideon Valstar for their outstanding efforts in and support to the HELPFul-ARGUS Study. We would like to thank Evelyn Velema, Merel Schurink and Marja Maat-Leersum for their contribution to the recruitment of participants and their aid in validating and processing the raw data. We also thank Danny Elbersen, Sander van de Weg, Nanique Tulkens, Naomi Parr, Hemse Al-Khamisi, Lianne Granneman and Thuur Peeters for work-up of the biobank samples. We thank Suzan Kemper-Bongers and the UPOD team for extracting and combining the regular care data for analysis. We thank all people involved from HeartLife Klinieken Utrecht and the Cardiology Center of the Netherlands, specifically the team at Cardiology Center Utrecht. We sincerely thank all people involved from the radiology department of the UMC Utrecht for their efforts to perform both CCTA and CMRI in this study. A special thanks to all patients who participated in the study.
Publisher Copyright:
© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2020/12/15
Y1 - 2020/12/15
N2 - INTRODUCTION: Chest pain or discomfort affects 20%-40% of the general population over the course of their life and may be a symptom of myocardial ischaemia. For the diagnosis of obstructive macrovascular coronary artery disease (CAD), algorithms have been developed; however, these do not exclude microvascular angina. This may lead to false reassurance of symptomatic patients, mainly women, with functionally significant, yet non-obstructive coronary vascular disease. Therefore, this study aims to estimate the prevalence of both macrovascular and microvascular coronary vascular disease in women and men presenting with chest pain or discomfort, and to subsequently develop a decision-support tool to aid cardiologists in referral to cardiovascular imaging for both macrovascular and microvascular CAD evaluation.METHODS AND ANALYSIS: Women and men with chest pain or discomfort, aged 45 years and older, without a history of cardiovascular disease, who are referred to an outpatient cardiology clinic by their general practitioner are eligible for inclusion. Coronary CT angiography is used for anatomical imaging. Additionally, myocardial perfusion imaging by adenosine stress cardiac MRI is performed to detect functionally significant coronary vascular disease. Electronic health record data, collected during regular cardiac work-up, including medical history, cardiovascular risk factors, physical examination, echocardiography, (exercise) ECG and blood samples for standard cardiovascular biomarkers and research purposes, are obtained. Participants will be classified as positive or negative for coronary vascular disease based on all available data by expert panel consensus (a cardiovascular radiologist and two cardiologists). After completion of the clinical study, all collected data will be used to develop a decision support tool using predictive modelling and machine-learning techniques.ETHICS AND DISSEMINATION: The study protocol was approved by the Institutional Review Board of the University Medical Center Utrecht. Results will be disseminated through national and international conferences and in peer-reviewed journals in cardiovascular disease.TRIAL REGISTRATION NUMBER: Trialregister.nl Registry NL8702.
AB - INTRODUCTION: Chest pain or discomfort affects 20%-40% of the general population over the course of their life and may be a symptom of myocardial ischaemia. For the diagnosis of obstructive macrovascular coronary artery disease (CAD), algorithms have been developed; however, these do not exclude microvascular angina. This may lead to false reassurance of symptomatic patients, mainly women, with functionally significant, yet non-obstructive coronary vascular disease. Therefore, this study aims to estimate the prevalence of both macrovascular and microvascular coronary vascular disease in women and men presenting with chest pain or discomfort, and to subsequently develop a decision-support tool to aid cardiologists in referral to cardiovascular imaging for both macrovascular and microvascular CAD evaluation.METHODS AND ANALYSIS: Women and men with chest pain or discomfort, aged 45 years and older, without a history of cardiovascular disease, who are referred to an outpatient cardiology clinic by their general practitioner are eligible for inclusion. Coronary CT angiography is used for anatomical imaging. Additionally, myocardial perfusion imaging by adenosine stress cardiac MRI is performed to detect functionally significant coronary vascular disease. Electronic health record data, collected during regular cardiac work-up, including medical history, cardiovascular risk factors, physical examination, echocardiography, (exercise) ECG and blood samples for standard cardiovascular biomarkers and research purposes, are obtained. Participants will be classified as positive or negative for coronary vascular disease based on all available data by expert panel consensus (a cardiovascular radiologist and two cardiologists). After completion of the clinical study, all collected data will be used to develop a decision support tool using predictive modelling and machine-learning techniques.ETHICS AND DISSEMINATION: The study protocol was approved by the Institutional Review Board of the University Medical Center Utrecht. Results will be disseminated through national and international conferences and in peer-reviewed journals in cardiovascular disease.TRIAL REGISTRATION NUMBER: Trialregister.nl Registry NL8702.
KW - cardiology
KW - cardiovascular imaging
KW - coronary heart disease
UR - http://www.scopus.com/inward/record.url?scp=85097912765&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2020-040712
DO - 10.1136/bmjopen-2020-040712
M3 - Article
C2 - 33323438
SN - 2044-6055
VL - 10
SP - 1
EP - 7
JO - BMJ Open
JF - BMJ Open
IS - 12
M1 - e040712
ER -