Early Detection of Silent Myocardial Ischemia

Last updated: April 29, 2021
Sponsor: Pim van der Harst
Overall Status: Active - Enrolling

Phase

N/A

Condition

Myocardial Ischemia

Vascular Diseases

Heart Defect

Treatment

N/A

Clinical Study ID

NCT04680338
NL64860.042.18
  • Ages > 45
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participation in ROBINSCA or ImaLife study
  • CT-CAC ≥300

Exclusion

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, valvularsurgery, other major cardiac surgery (e.g. cardiac transplantation) and/or previousinvasive coronary angiography or catheter ablation)
  • Contra-indication for stress CMR perfusion imaging (claustrophobia, CMR incompatibledevice (e.g., Implantable Cardioverter Defibrillator/pacemaker), contrast agent orvasodilator intolerance, contra-indications for adenosine or regadenoson (e.g. 2nd/3rddegree 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

Total Participants: 1400
Study Start date:
May 27, 2019
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • University Medical Center Groningen

    Groningen, 9713 GZ
    Netherlands

    Site Not Available

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