Assessment of Cardiac Fibrosis in HCM Using FAPI-PET/MR

JRCT ID: jRCTs051240167

Registered date:23/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Hypertrophic Cardiomyopathy
• Date of first enrollment: 23/10/2024
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Perform 68Ga-FAPI PET/MR, contrast-enhanced MRI examinations, and blood sampling.

Outcome(s)

• Primary Outcome: For the total cardiac fibrosis burden in patients with HCM, evaluate the correlation between the amount of fibrosis expressed by FAPI-PET (product of SUVmean and region of interest) in the myocardium as calculated by contrast enhanced cardiac MRI.

Secondary Outcome

To compare the imaging results of FAPI-PET/MR and conventional contrast enhanced cardiac MRI between severe HCM patients and regular HCM patients, and evaluate the extent of fibrosis or damage indicated by each technique.
To assess the correlation between the polygenic score and the imaging results of FAPI-PET/MR and conventional contrast enhanced cardiac MRI in HCM patients (both severe and regular).
To evaluate the relationship between risk score for sudden cardiac death score and the imaging results of FAPI-PET/MR and conventional contrast enhanced cardiac MRI between the severe HCM group and the regular HCM group.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

1) Diagnosed with HCM by a cardiologist, the patient has been enrolled in the "Prospective Registry for Evaluating the Clinical Diagnosis of Hypertrophic Cardiomyopathy (PREVAIL-HCM)" clinical trial, led by Kyoto University.
2) Performed contrast-enhanced cardiac MRI in Kyoto University Hospital

Exclude criteria

Pregnant or possibly pregnant.
Extremely poor general condition (vital sign abnormalities, systolic blood pressure below 90 mmHg, heart rate over 100, etc.) or significant communication impairment.
Contraindications to FAPI-PET/MR or gadolinium-enhanced cardiac MRI.
(History of allergy to the administered agent, eGFR less than 30 ml/min/1.73 m2)
Other patients deemed unsuitable as study subjects by the principal investigator, the responsible investigator, or the co-investigator.

Related Information

• Primary Sponsor: Ono Koh