High Relaxivity Contrast Agent for Myocardial Fibrosis

Recruiting in Palo Alto (17 mi)

Overseen byJoao Lima, Professor

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Johns Hopkins University

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial tests Elucirem, a special dye for MRI scans, in adults and children aged 2+ to improve imaging of lesions with abnormal blood vessels. Elucirem enhances MRI images, making it easier to see problem areas. The study aims to find the best dose for clear imaging. Elucirem is a special dye used to improve MRI scans.

Eligibility Criteria

This trial is for adults over 21 years old who have previously participated in a cardiac MR study with Dotarem, are not claustrophobic, weigh under 120kg, and have normal kidney function (eGFR of 60 or more). It's not for those with metal fragments in sensitive areas, pregnant women, people with internal electrical devices like pacemakers, anyone allergic to gadolinium-based contrast agents or those unable to undergo MRI due to severe conditions.

Inclusion Criteria

I was in the previous Doatrem CMR study and agree to join this one.

I am over 21, weigh less than 120kg, not afraid of tight spaces, and my kidney function is normal.

Exclusion Criteria

I am younger than 21 years old.

I cannot have an MRI due to kidney issues, metal implants, pregnancy, allergies to MRI dye, or severe claustrophobia.

Participant Groups

The trial tests if a half dose of Elucirem (0.05mmol/kg), a new high relaxivity contrast agent for MRI scans, is as effective as a double dose (0.2 mmol/kg) of the already approved agent Dotarem in assessing myocardial scars during cardiac MR imaging.

2Treatment groups

Experimental Treatment

Group I: 0.075 mmol/kg EluciremExperimental Treatment1 Intervention

A group that receives 0.075 mmol/kg Elucirem

Group II: 0.05 mmol/kg EluciremExperimental Treatment1 Intervention

a group that receives 0.05 mmol/kg Elucirem