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Enrolling by Invitation

NCT Number: NCT06697509

Improved Detection of Myocardial Fibrosis: a Cardiovascular Magnetic Resonance Imaging Study

Myocardial fibrosis, or scarring, is a common endpoint in many cardiomyopathies and is associated with adverse outcomes, and precise tools to measure myocardial fibrosis are needed. Focal and diffuse myocardial fibrosis can be diagnosed by cardiovascular magnetic resonance (CMR) imaging. However, the CMR procedure is complex and time-consuming and require the use of intravenous gadolinium based contrast agents. A wide range of biomarkers have been associated with the diagnosis and prognosis of cardiovascular disease. In the current study the investigators will assess whether novel and established circulating myocardial biomarkers associate with myocardial fibrosis assessed by CMR. The investigators will also assess whether novel or improved CMR sequences as well as machine learning algorithms improve image quality and the detection of myocardial fibrosis.

Enrolling by Invitation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Akershus University Hospital

Lørenskog, Norge, 1474, Norway

About this study

This is an observational study of adult patients with suspected myocardial disease referred to cardiovascular magnetic resonance (CMR) with gadolinium contrast. The goal of the study is to assess whether novel and established circulating myocardial biomarkers associate with myocardial fibrosis assessed by CMR. The investigators will also assess novel techniques for detecting myocardial fibrosis by CMR. The plan is to include 1000 patients prior to CMR at Akershus University Hospital.

Blood samples for biomarker measurement will be obtained at the time of CMR. Image quality of novel CMR sequences will be recorded. The diagnostic results of the CMR will be compared to the levels of selected circulating biomarkers of myocardial injury and fibrosis. Novel sequences and techniques for assessing myocardial fibrosis by CMR will be compare to established techniques. Patients will be followed for a minimum of 12 months and the incidence of cardiovascular death, all-cause mortality, acute coronary syndromes, revascularization, heart failure, stroke and cardiac arrhythmias requiring rehospitalization will be recorded. Long-term follow-up information will be obtained from relevant registries

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Consecutive adult patients referred for clinically indicated cardiovascular magnetic resonance (CMR) imaging with gadolinium contrast at Akershus University Hospital will be invited to participate.

Exclusion criteria

Participants with contraindication for gadolinium contrast or inability to consent will be excluded

Treatment and study plan

Primary outcomes

  1. The presence of focal or diffuse myocardial fibrosis

    Time frame: Baseline

    Focal myocardial fibrosis assessed by late gadolinium enhancement (LGE) and diffuse myocardial fibrosis assessed by the extracellular volume fraction (ECV) by cardiovascular magnetic resonance (CMR) imaging

Secondary outcomes

  1. Composite of cardiovascular death and major adverse cardiac events (MACE)

    Time frame: Up to seven years

    Prognostic endpoint

Sponsors and collaborators

Lead sponsor

University Hospital, Akershus

Other

Registry information

Official study title

Improved Detection of Myocardial Fibrosis: a CMR Study

Important dates

Study start
2024
Primary completion
2028
Study completion
2032
First posted
Nov 20, 2024
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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