EarlySynergy: Early Detection of Silent Myocardial Ischemia
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Cardiac magnetic resonance imaging Cardiac magnetic resonance (CMR) stress perfusion imaging with feedback of clinically actionable findings |
Diagnostic Test: CMR stress perfusion imaging
CMR stress perfusion imaging with feedback of clinically actionable findings to general practitioner and participant
|
| No Intervention: Control No intervention, following the natural course of coronary atherosclerosis |
Outcome Measures
Primary Outcome Measures
- Rate of major adverse cardiac events [1 year]
Cardiovascular death, non-fatal myocardial infarction or hospitalization for unstable angina, heart failure or resuscitated cardiac arrest
- Rate of major adverse cardiac events [2.5 years]
Cardiovascular death, non-fatal myocardial infarction or hospitalization for unstable angina, heart failure or resuscitated cardiac arrest
- Rate of major adverse cardiac events [5 years]
Cardiovascular death, non-fatal myocardial infarction or hospitalization for unstable angina, heart failure or resuscitated cardiac arrest
- Diagnostic yield of CMR stress perfusion imaging [Baseline]
Prevalence and extent of silent myocardial ischemia and cardiac dysfunction
Secondary Outcome Measures
- Rate of individual components of primary outcome 1 [1 year]
Cardiovascular death, non-fatal myocardial infarction or hospitalization for unstable angina, heart failure or resuscitated cardiac arrest
- Rate of individual components of primary outcome 1 [2.5 years]
Cardiovascular death, non-fatal myocardial infarction or hospitalization for unstable angina, heart failure or resuscitated cardiac arrest
- Rate of individual components of primary outcome 1 [5 years]
Cardiovascular death, non-fatal myocardial infarction or hospitalization for unstable angina, heart failure or resuscitated cardiac arrest
- All-cause mortality rate [1 year]
Death from any disease
- All-cause mortality rate [2.5 years]
Death from any disease
- All-cause mortality rate [5 years]
Death from any disease
- Rate of invasive cardiovascular procedures [1 year]
percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG) surgery, invasive coronary angiography (ICA) and other invasive cardiovascular procedures
- Rate of invasive cardiovascular procedures [2.5 years]
percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG) surgery, invasive coronary angiography (ICA) and other invasive cardiovascular procedures
- Rate of invasive cardiovascular procedures [5 years]
percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG) surgery, invasive coronary angiography (ICA) and other invasive cardiovascular procedures
- Rate of hospitalization for cardiovascular disease [1, 2.5, 5 years]
Hospitalization for cardiovascular disease (e.g. stroke, peripheral vascular disease)
- Rate of hospitalization for cardiovascular disease [1 year]
Hospitalization for cardiovascular disease (e.g. stroke, peripheral vascular disease)
- Rate of hospitalization for cardiovascular disease [2.5 years]
Hospitalization for cardiovascular disease (e.g. stroke, peripheral vascular disease)
- Rate of non-invasive cardiac imaging procedures [5 years]
Rate of non-invasive cardiac imaging procedures (e.g., myocardial stress perfusion imaing, echocardiography)
- Rate of medical therapy initiation [1 year]
Initiation of preventive or cardio-active medication (e.g., ACE-inhibiters, statins, calcium antagonists, beta-blockers etc.)
- Rate of medical therapy initiation [2.5 years]
Initiation of preventive or cardio-active medication (e.g., ACE-inhibiters, statins, calcium antagonists, beta-blockers etc.)
- Rate of medical therapy initiation [5 years]
Initiation of preventive or cardio-active medication (e.g., ACE-inhibiters, statins, calcium antagonists, beta-blockers etc.)
- Quality of Life as reflected by EQ-5D-5S score [1 year]
Quality of life as assessed by EQ-5D-5S questionnaire
- Quality of Life as reflected by EQ-5D-5S score [2.5 years]
Quality of life as assessed by EQ-5D-5S questionnaire
- Quality of Life as reflected by EQ-5D-5S score [5 years]
Quality of life as assessed by EQ-5D-5S questionnaire
- Quality of Life as reflected by HeartQoL score [1 year]
Quality of life as assessed by HeartQoL questionnaire
- Quality of Life as reflected by HeartQoL score [2.5 years]
Quality of life as assessed by HeartQoL questionnaire
- Quality of Life as reflected by HeartQoL score [5 years]
Quality of life as assessed by HeartQoL questionnaire
Other Outcome Measures
- Cost-effectiveness [1 year]
Cost-effectiveness of CMR stress perfusion imaging compared to control group
- Cost-effectiveness [2.5 years]
Cost-effectiveness of CMR stress perfusion imaging compared to control group
- Cost-effectiveness [5 years]
Cost-effectiveness of CMR stress perfusion imaging compared to control group
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Participation in ROBINSCA or ImaLife study
-
CT-CAC ≥300
Exclusion Criteria:
-
History of ischemic heart disease or other cardiac disease (myocardial infarction, sudden cardiac arrest, heart failure, cardiomyopathy, congenital cardiac disease, percutaneous coronary intervention, coronary artery bypass grafting surgery, valvular surgery, other major cardiac surgery (e.g. cardiac transplantation) and/or previous invasive coronary angiography or catheter ablation)
-
Contra-indication for stress CMR perfusion imaging (claustrophobia, CMR incompatible device (e.g., Implantable Cardioverter Defibrillator/pacemaker), contrast agent or vasodilator intolerance, contra-indications for adenosine or regadenoson (e.g. 2nd/3rd degree atrioventricular block, severe hypotension) and/or weight > 125 kg)
-
Severe comorbidity and/or a life expectancy of less than 1 year
-
Unable to provide written informed consent
-
Pregnancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Medical Center Groningen | Groningen | Netherlands | 9713 GZ |
Sponsors and Collaborators
- Pim van der Harst
Investigators
- Principal Investigator: Pim van der Harst, MD, PhD, University Medical Center Groningen
Study Documents (Full-Text)
None provided.More Information
Publications
- Vonder M, van der Aalst CM, Vliegenthart R, van Ooijen PMA, Kuijpers D, Gratama JW, de Koning HJ, Oudkerk M. Coronary Artery Calcium Imaging in the ROBINSCA Trial: Rationale, Design, and Technical Background. Acad Radiol. 2018 Jan;25(1):118-128. doi: 10.1016/j.acra.2017.07.010. Epub 2017 Aug 23. Review.
- Xia C, Rook M, Pelgrim GJ, Sidorenkov G, Wisselink HJ, van Bolhuis JN, van Ooijen PMA, Guo J, Oudkerk M, Groen H, van den Berge M, van der Harst P, Dijkstra H, Vonder M, Heuvelmans MA, Dorrius MD, De Deyn PP, de Bock GH, Dotinga A, Vliegenthart R. Early imaging biomarkers of lung cancer, COPD and coronary artery disease in the general population: rationale and design of the ImaLife (Imaging in Lifelines) Study. Eur J Epidemiol. 2020 Jan;35(1):75-86. doi: 10.1007/s10654-019-00519-0. Epub 2019 Apr 23.
- NL64860.042.18