CompletedNot Applicable

Efficacy of Dotarem® (Gd-DOTA) Versus Gadovist® (Gd-DO3A-butrol) for Late Gadolinium Enhancement Cardiac Magnetic Resonance

120 participantsStarted 2016-10-01

Plain-language summary

This project is designed to demonstrate equivalence of Dotarem enhanced LGE-CMR (late gadolinium enhancement cardiac MRI) with Gadoviost enhanced LGE-CMR from the standpoint of visual image quality, quantitative image quality, and association with clinical outcomes.

Who can participate

Age range18 Years – 99 Years

SexALL

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Exclusion criteria

✕. Patients who are unable to give informed consent.
✕. Individuals with severe claustrophobia.
✕. Individuals unable to lie flat for 90 minutes (the anticipated amount of time to complete the MRI procedure).
✕. Individuals who are pregnant.
✕. Patients with implants or pacemakers.
✕. Patients that have hypersensitivity to components of gadolinium.
✕. Patients with renal failure.
✕. Patients who had any trauma or surgery which may have left ferromagnetic material in the body.

What they're measuring

Compare visual image quality of LGE-CMR when performed with Dotarem or Gadovist in a randomized fashion.

Timeframe: Two years

Compare quantitative signal enhancement of LGE when performed with Dotarem or Gadovist in a randomized fashion.

Timeframe: Two Years

Compare association of LGE and clinical cardiovascular outcomes when performed with Dotarem or Gadovistin a randomized fashion.

Timeframe: Eight years

Trial details

NCT IDNCT03057561

SponsorThe Methodist Hospital Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-12-31

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