Early Detection of Silent Myocardial Ischemia

NCT04680338 | Unknown

• 1 other identifier: NL64860.042.18
• Study Type: interventional
• Target: 1,400
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Heart Disease; Silent Myocardial Ischemia; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (4)

• Rate of major adverse cardiac events

  Cardiovascular death, non-fatal myocardial infarction or hospitalization for unstable angina, heart failure or resuscitated cardiac arrest

  1 year

• Rate of major adverse cardiac events

  Cardiovascular death, non-fatal myocardial infarction or hospitalization for unstable angina, heart failure or resuscitated cardiac arrest

  2.5 years

• Rate of major adverse cardiac events

  Cardiovascular death, non-fatal myocardial infarction or hospitalization for unstable angina, heart failure or resuscitated cardiac arrest

  5 years

• Diagnostic yield of CMR stress perfusion imaging

  Prevalence and extent of silent myocardial ischemia and cardiac dysfunction

  Baseline

Secondary Outcomes (22)

• Rate of individual components of primary outcome 1

  1 year

• Rate of individual components of primary outcome 1

  2.5 years

• Rate of individual components of primary outcome 1

  5 years

• All-cause mortality rate

  1 year

• All-cause mortality rate

  2.5 years

Other Outcomes (3)

• Cost-effectiveness

  1 year

• Cost-effectiveness

  2.5 years

• Cost-effectiveness

  5 years

Study Arms (2)

Cardiac magnetic resonance imaging

ACTIVE COMPARATOR

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

Diagnostic Test: CMR stress perfusion imaging

Control

NO INTERVENTION

No intervention, following the natural course of coronary atherosclerosis

Interventions

CMR stress perfusion imaging DIAGNOSTIC_TEST

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

Cardiac magnetic resonance imaging

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pim van der Harst: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 31016436 BACKGROUND

• 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.

  PMID: 28843465 BACKGROUND

MeSH Terms

Conditions

Myocardial Ischemia; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Vascular Diseases

Study Officials

• Pim van der Harst, MD, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical professor, Principal Investigator

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: December 22, 2020
• Study Start: May 27, 2019
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2024
• Last Updated: April 30, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: In accordance with legal period for study data storage
• Access Criteria: In correspondence with the principal investigator

Locations

NL (1)