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

Improved Detection of Myocardial Fibrosis: a CMR 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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Myocardial Diseases

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

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• Norway
  • Norge
    • Lørenskog, Norge, Norway, 1474
      • Akershus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with suspected or established myocardial disease referred for CMR; Consenting adult patients with suspected or established myocardial disease referred for cardiovascular magnetic resonance (CMR) imaging with gadolinium contrast at Akershus University Hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The presence of focal or diffuse myocardial fibrosis	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	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of cardiovascular death and major adverse cardiac events (MACE)	Prognostic endpoint	Up to seven years

Collaborators and Investigators

• Sponsor: University Hospital, Akershus

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2024
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2032

Study Registration Dates

• First Submitted: November 18, 2024
• First Submitted That Met QC Criteria: November 19, 2024
• First Posted (Estimated): November 20, 2024

Study Record Updates

• Last Update Posted (Estimated): November 20, 2024
• Last Update Submitted That Met QC Criteria: November 19, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Biomarkers; CMR; Cardiovascular Magnetic Resonance Imaging; Myocardial fibrosis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Fibrosis; Cardiomyopathies
• Other Study ID Numbers: 452039

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data from the study cannot be publicly shared because of the risk for violating privacy, as regulated by the institutional data protection officer.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No