Early Detection of Silent Myocardial Ischemia

Cardiovascular Diseases Clinical Trial

— EarlySynergy  

Official title:

Early Detection of Silent Myocardial Ischemia and Cardiac Dysfunction in Asymptomatic Individuals With Increased Coronary Artery Calcium Scores

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04680338
• Other study ID #: NL64860.042.18
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 27, 2019
• Est. completion date: December 2024

Study information

• Verified date: April 2021
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Coronary Artery Disease
• Heart Diseases
• Ischemia
• Ischemic Heart Disease
• Myocardial Ischemia
• Silent Myocardial Ischemia

Intervention

Diagnostic Test:
• CMR stress perfusion imaging
CMR stress perfusion imaging with feedback of clinically actionable findings to general practitioner and participant

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
Pim van der Harst

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

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

Outcome

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