Early Detection of Silent Myocardial Ischemia

Not Applicable

• Conditions: Cardiovascular Diseases; Ischemic Heart Disease; Silent Myocardial Ischemia
• Interventions: Diagnostic Test: CMR stress perfusion imaging

• Registration Number: NCT04680338
• Lead Sponsor: Pim van der Harst

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.

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 Timeline

• Study Start: 2019-05-27
• Study First Submitted: 2020-12-11
• Study First Submitted QC: 2020-12-17
• Study First Posted: 2020-12-22
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-29
• Last Update Posted: 2021-04-30
• Primary Completion: 2021-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 1400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cardiac magnetic resonance imaging	CMR stress perfusion imaging	Cardiac magnetic resonance (CMR) stress perfusion imaging with feedback of clinically actionable findings

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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	5 years	Death from any disease
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	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	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	5 years	Quality of life as assessed by EQ-5D-5S questionnaire
Quality of Life as reflected by HeartQoL score	5 years	Quality of life as assessed by HeartQoL questionnaire

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands