Clinical trial NCT06697509: Improved Detection of Myocardial Fibrosis: a Cardiovascular Magnetic Resonance Imaging Study
Official title: Improved Detection of Myocardial Fibrosis: a CMR Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Myocardial Diseases
Keywords: CMR
Myocardial fibrosis
Biomarkers
Cardiovascular Magnetic Resonance Imaging
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This is an observational study of patients with suspected myocardial disease referred to in-patient or out-patient cardiovascular magnetic resonance (CMR) examination with gadolinium contrast

Brief summary: 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.

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: The presence of focal or diffuse myocardial fibrosis
timeFrame: Baseline
Secondary outcomes:
measure: Composite of cardiovascular death and major adverse cardiac events (MACE)
timeFrame: Up to seven years
Other outcomes:
Locations:
city: Lørenskog
country: Norway
facility: Akershus University Hospital
state: Norge
Study officials:
References: