Trials / Unknown
UnknownNCT04680338
Early Detection of Silent Myocardial Ischemia
Early Detection of Silent Myocardial Ischemia and Cardiac Dysfunction in Asymptomatic Individuals With Increased Coronary Artery Calcium Scores
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,400 (estimated)
- Sponsor
- Pim van der Harst · Academic / Other
- Sex
- All
- Age
- 45 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | CMR stress perfusion imaging | CMR stress perfusion imaging with feedback of clinically actionable findings to general practitioner and participant |
Timeline
- Start date
- 2019-05-27
- Primary completion
- 2021-12-01
- Completion
- 2024-12-01
- First posted
- 2020-12-22
- Last updated
- 2021-04-30
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT04680338. Inclusion in this directory is not an endorsement.