Cardiovascular Diseases Clinical Trial
— EarlySynergyOfficial title:
Early Detection of Silent Myocardial Ischemia and Cardiac Dysfunction in Asymptomatic Individuals With Increased Coronary Artery Calcium Scores
Verified date | April 2021 |
Source | University Medical Center Groningen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 1400 |
Est. completion date | December 2024 |
Est. primary completion date | December 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 45 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | University Medical Center Groningen | Groningen |
Lead Sponsor | Collaborator |
---|---|
Pim van der Harst |
Netherlands,
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Cost-effectiveness | Cost-effectiveness of CMR stress perfusion imaging compared to control group | 1 year | |
Other | Cost-effectiveness | Cost-effectiveness of CMR stress perfusion imaging compared to control group | 2.5 years | |
Other | Cost-effectiveness | Cost-effectiveness of CMR stress perfusion imaging compared to control group | 5 years | |
Primary | Rate of major adverse cardiac events | Cardiovascular death, non-fatal myocardial infarction or hospitalization for unstable angina, heart failure or resuscitated cardiac arrest | 1 year | |
Primary | Rate of major adverse cardiac events | Cardiovascular death, non-fatal myocardial infarction or hospitalization for unstable angina, heart failure or resuscitated cardiac arrest | 2.5 years | |
Primary | Rate of major adverse cardiac events | Cardiovascular death, non-fatal myocardial infarction or hospitalization for unstable angina, heart failure or resuscitated cardiac arrest | 5 years | |
Primary | Diagnostic yield of CMR stress perfusion imaging | Prevalence and extent of silent myocardial ischemia and cardiac dysfunction | Baseline | |
Secondary | 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 | 1 year | |
Secondary | 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 | 2.5 years | |
Secondary | 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 | 5 years | |
Secondary | All-cause mortality rate | Death from any disease | 1 year | |
Secondary | All-cause mortality rate | Death from any disease | 2.5 years | |
Secondary | All-cause mortality rate | Death from any disease | 5 years | |
Secondary | Rate of invasive cardiovascular procedures | percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG) surgery, invasive coronary angiography (ICA) and other invasive cardiovascular procedures | 1 year | |
Secondary | Rate of invasive cardiovascular procedures | percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG) surgery, invasive coronary angiography (ICA) and other invasive cardiovascular procedures | 2.5 years | |
Secondary | Rate of invasive cardiovascular procedures | percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG) surgery, invasive coronary angiography (ICA) and other invasive cardiovascular procedures | 5 years | |
Secondary | Rate of hospitalization for cardiovascular disease | Hospitalization for cardiovascular disease (e.g. stroke, peripheral vascular disease) | 1, 2.5, 5 years | |
Secondary | Rate of hospitalization for cardiovascular disease | Hospitalization for cardiovascular disease (e.g. stroke, peripheral vascular disease) | 1 year | |
Secondary | Rate of hospitalization for cardiovascular disease | Hospitalization for cardiovascular disease (e.g. stroke, peripheral vascular disease) | 2.5 years | |
Secondary | Rate of non-invasive cardiac imaging procedures | Rate of non-invasive cardiac imaging procedures (e.g., myocardial stress perfusion imaing, echocardiography) | 5 years | |
Secondary | Rate of medical therapy initiation | Initiation of preventive or cardio-active medication (e.g., ACE-inhibiters, statins, calcium antagonists, beta-blockers etc.) | 1 year | |
Secondary | Rate of medical therapy initiation | Initiation of preventive or cardio-active medication (e.g., ACE-inhibiters, statins, calcium antagonists, beta-blockers etc.) | 2.5 years | |
Secondary | Rate of medical therapy initiation | Initiation of preventive or cardio-active medication (e.g., ACE-inhibiters, statins, calcium antagonists, beta-blockers etc.) | 5 years | |
Secondary | Quality of Life as reflected by EQ-5D-5S score | Quality of life as assessed by EQ-5D-5S questionnaire | 1 year | |
Secondary | Quality of Life as reflected by EQ-5D-5S score | Quality of life as assessed by EQ-5D-5S questionnaire | 2.5 years | |
Secondary | Quality of Life as reflected by EQ-5D-5S score | Quality of life as assessed by EQ-5D-5S questionnaire | 5 years | |
Secondary | Quality of Life as reflected by HeartQoL score | Quality of life as assessed by HeartQoL questionnaire | 1 year | |
Secondary | Quality of Life as reflected by HeartQoL score | Quality of life as assessed by HeartQoL questionnaire | 2.5 years | |
Secondary | Quality of Life as reflected by HeartQoL score | Quality of life as assessed by HeartQoL questionnaire | 5 years |
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