Early Detection of Silent Myocardial Ischemia

NCT ID: NCT04680338

Last Updated: 2021-04-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-27
• Study Completion Date: 2024-12-31

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.

Conditions

Ischemic Heart Disease; Silent Myocardial Ischemia; Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Cardiac magnetic resonance imaging

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

Group Type: ACTIVE_COMPARATOR

CMR stress perfusion imaging

Intervention Type: DIAGNOSTIC_TEST

CMR stress perfusion imaging with feedback of clinically actionable findings to general practitioner and participant

Control

No intervention, following the natural course of coronary atherosclerosis

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

CMR stress perfusion imaging

CMR stress perfusion imaging with feedback of clinically actionable findings to general practitioner and participant

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pim van der Harst

OTHER

Sponsor Role: lead

Responsible Party

Pim van der Harst

Clinical professor, Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Pim van der Harst, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

University Medical Center Groningen

Groningen, , Netherlands

Countries

Netherlands

References

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.

Reference Type: BACKGROUND

PMID: 31016436 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28843465 (View on PubMed)

Other Identifiers

NL64860.042.18

Identifier Type: -

Identifier Source: org_study_id