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

NCT06697509 | Enrolling By Invitation

• 1 other identifier: 452039
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Diseases

Keywords

CMR; Myocardial fibrosis; Biomarkers; Cardiovascular Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  Up to seven years

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Akershus: lead

Study Sites (1)

Akershus University Hospital

Lørenskog, Norge, 1474, Norway

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be obtained by venipuncture by dedicated study personnel in relation to the routine pre-procedural clinical examination conducted the same day or the day before the cardiovascular magnetic resonance (CMR) examination

MeSH Terms

Conditions

Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor and consultant radiologist

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 20, 2024
• Study Start: August 22, 2024
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2032
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)