Status:
UNKNOWN
Early Detection of Silent Myocardial Ischemia
Lead Sponsor:
Pim van der Harst
Conditions:
Ischemic Heart Disease
Silent Myocardial Ischemia
Eligibility:
All Genders
45+ years
Phase:
NA
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 diagnost...
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...
Eligibility Criteria
Inclusion
- Participation in ROBINSCA or ImaLife study
- CT-CAC ≥300
Exclusion
- 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
Key Trial Info
Start Date :
May 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
1400 Patients enrolled
Trial Details
Trial ID
NCT04680338
Start Date
May 27 2019
End Date
December 1 2024
Last Update
April 30 2021
Active Locations (1)
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1
University Medical Center Groningen
Groningen, Netherlands, 9713 GZ