Early-Synergy investigates a diagnostic imaging approach in asymptomatic individuals from the general population for early detection of silent myocardial ischemia and cardiac dysfunction. The diagnostic imaging approach consists of cardiac computed tomography for coronary artery calcium scoring (CT-CAC) and cardiac magnetic resonance (CMR) stress perfusion imaging. Early-Synergy investigates the effect of early detection of silent myocardial ischemia and cardiac dysfunction by CMR in asymptomatic individuals with increased CAC. In addition, the diagnostic yield of CMR for early detection of silent myocardial ischemia and cardiac dysfunction is investigated. Asymptomatic individuals at increased risk (CAC ≥ 300) are therefore randomized 1:1 to either CMR stress perfusion imaging or a control group.
Early-Synergy is a prospective multi-center study performed in the Netherlands. Potential candidates for participation in Early-Synergy have had CT-CAC scanning as part of participation in two ongoing population-based studies (ROBINSCA and ImaLife) and had CAC ≥300. Participants are randomized in a 1:1 fashion to (1.) CMR stress perfusion imaging with feedback of clinically actionable findings or (2.) control group. In the CMR group, feedback on CMR stress perfusion imaging is provided to the participant and general practitioner only in case of CMR findings that require further management based on current clinical guidelines. Participants in the control group will not receive stress CMR perfusion imaging but will be followed in time to evaluate the clinical presentation of the natural course of coronary atherosclerosis. Follow-up will be performed up to 5 years in both groups by sending questionnaires and collecting medical information from health care providers and registries. Additionally, blood is drawn from participants in the CMR group during the hospital visit for CMR scanning and is stored to allow evaluation of cardiac blood markers as predictors of CMR findings.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1,400
CMR stress perfusion imaging with feedback of clinically actionable findings to general practitioner and participant
University Medical Center Groningen
Groningen, Netherlands
Rate of major adverse cardiac events
Cardiovascular death, non-fatal myocardial infarction or hospitalization for unstable angina, heart failure or resuscitated cardiac arrest
Time frame: 1 year
Rate of major adverse cardiac events
Cardiovascular death, non-fatal myocardial infarction or hospitalization for unstable angina, heart failure or resuscitated cardiac arrest
Time frame: 2.5 years
Rate of major adverse cardiac events
Cardiovascular death, non-fatal myocardial infarction or hospitalization for unstable angina, heart failure or resuscitated cardiac arrest
Time frame: 5 years
Diagnostic yield of CMR stress perfusion imaging
Prevalence and extent of silent myocardial ischemia and cardiac dysfunction
Time frame: Baseline
Rate of individual components of primary outcome 1
Cardiovascular death, non-fatal myocardial infarction or hospitalization for unstable angina, heart failure or resuscitated cardiac arrest
Time frame: 1 year
Rate of individual components of primary outcome 1
Cardiovascular death, non-fatal myocardial infarction or hospitalization for unstable angina, heart failure or resuscitated cardiac arrest
Time frame: 2.5 years
Rate of individual components of primary outcome 1
Cardiovascular death, non-fatal myocardial infarction or hospitalization for unstable angina, heart failure or resuscitated cardiac arrest
Time frame: 5 years
All-cause mortality rate
Death from any disease
Time frame: 1 year
All-cause mortality rate
Death from any disease
Time frame: 2.5 years
All-cause mortality rate
Death from any disease
Time frame: 5 years
Rate of invasive cardiovascular procedures
percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG) surgery, invasive coronary angiography (ICA) and other invasive cardiovascular procedures
Time frame: 1 year
Rate of invasive cardiovascular procedures
percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG) surgery, invasive coronary angiography (ICA) and other invasive cardiovascular procedures
Time frame: 2.5 years
Rate of invasive cardiovascular procedures
percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG) surgery, invasive coronary angiography (ICA) and other invasive cardiovascular procedures
Time frame: 5 years
Rate of hospitalization for cardiovascular disease
Hospitalization for cardiovascular disease (e.g. stroke, peripheral vascular disease)
Time frame: 1, 2.5, 5 years
Rate of hospitalization for cardiovascular disease
Hospitalization for cardiovascular disease (e.g. stroke, peripheral vascular disease)
Time frame: 1 year
Rate of hospitalization for cardiovascular disease
Hospitalization for cardiovascular disease (e.g. stroke, peripheral vascular disease)
Time frame: 2.5 years
Rate of non-invasive cardiac imaging procedures
Rate of non-invasive cardiac imaging procedures (e.g., myocardial stress perfusion imaing, echocardiography)
Time frame: 5 years
Rate of medical therapy initiation
Initiation of preventive or cardio-active medication (e.g., ACE-inhibiters, statins, calcium antagonists, beta-blockers etc.)
Time frame: 1 year
Rate of medical therapy initiation
Initiation of preventive or cardio-active medication (e.g., ACE-inhibiters, statins, calcium antagonists, beta-blockers etc.)
Time frame: 2.5 years
Rate of medical therapy initiation
Initiation of preventive or cardio-active medication (e.g., ACE-inhibiters, statins, calcium antagonists, beta-blockers etc.)
Time frame: 5 years
Quality of Life as reflected by EQ-5D-5S score
Quality of life as assessed by EQ-5D-5S questionnaire
Time frame: 1 year
Quality of Life as reflected by EQ-5D-5S score
Quality of life as assessed by EQ-5D-5S questionnaire
Time frame: 2.5 years
Quality of Life as reflected by EQ-5D-5S score
Quality of life as assessed by EQ-5D-5S questionnaire
Time frame: 5 years
Quality of Life as reflected by HeartQoL score
Quality of life as assessed by HeartQoL questionnaire
Time frame: 1 year
Quality of Life as reflected by HeartQoL score
Quality of life as assessed by HeartQoL questionnaire
Time frame: 2.5 years
Quality of Life as reflected by HeartQoL score
Quality of life as assessed by HeartQoL questionnaire
Time frame: 5 years
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