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NCT01890421 · ClinicalTrials.gov registry record · Phase 3

Gadobutrol/Gadavist-enhanced Cardiac Magnetic Resonance Imaging (CMRI) to Detect Coronary Artery Disease (CAD)

A Phase 3 study of Coronary Artery Disease, sponsored by Bayer.

Completed
Registry status
Phase 3
Development phase
426
Enrollment target
20
Study locations

NCT01890421: Completed Phase 3 study of Coronary Artery Disease, sponsored by Bayer.

NCT01890421 is a Phase 3 study of Coronary Artery Disease that has completed, run by Bayer. The registered enrollment target is 426 participants, below the 1,285-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (67% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01890421, a Phase 3 study of Coronary Artery Disease, has completed, sponsored by Bayer.

COMPLETED
Registry status
Phase 3
Development phase
426 participants
Enrollment target
20
Study locations

Study Summary

Participants being evaluated for suspected or known Coronary artery Disease (CAD) based on signs and/or symptoms, will be invited to participate in the study. The duration for a participant in the study may range from 2 days to 4-6 weeks. One to four visits to the study doctor will be required. This study will investigate the diagnostic results of gadobutrol-enhanced Cardiac Magnetic Resonance Imaging (CMRI) images regarding the detection (sensitivity) and exclusion (specificity) of coronary artery disease utilizing a uniform image acquisition software. The CMR images will be tested either against the results from routine clinical Coronary Angiography (CA) or those from Computed Tomography Angiography (CTA), which is used as the standard of reference. The CA/CTA may have been performed up to 4 weeks prior to enrollment or be scheduled up to 4/6 weeks after the study. CMRI and CA/CTA images will be collected for an independent image review (blinded read).

Primary Outcome

Blinded readers evaluated 6 myocardial regions based on regional perfusion score (RPS), 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)\]. A myocardial region a perfusion defect in case of a RPS of \>=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as quantitative coronary angiography (QCA) sten

Conditions Studied

Coronary Artery Disease

Interventions

  • DRUG Gadobutrol (Gadovist, Gadavist, BAY86-4875)

Study Locations (20)

Other

  • - Marseille
  • - Saint-Etienne
  • - Berlin
  • - Berlin
  • - Berlin
  • - Auckland
  • - Incheon
  • - Seoul
  • - Seoul
  • - Yangsan

Baden-Wurttemberg

  • - Bad Krozingen
  • - Stuttgart
  • - Tübingen

North Rhine-Westphalia

  • - Bonn
  • - Essen

Minnesota

  • - Minneapolis

Hesse

  • - Darmstadt

Lower Saxony

  • - Göttingen

Saxony

  • - Leipzig

Canton Ticino

  • - Lugano

Trial Details

FieldValue
Enrollment Target 426 participants
Start Date 2013-07-19
Est. Completion 2017-08-31
Phase Phase 3
Bayer

591 total trials

What the finished NCT01890421 record still lists

NCT01890421 is an interventional study that assigns participants to a tested intervention. The registered 426 participants enrollment target is mid-sized for trials with a published cap, below the 1,285-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (67% lower).

The record links to 1 condition, with Coronary Artery Disease appearing as the primary indexed condition, and to 1 intervention - of which Gadobutrol (Gadovist, Gadavist, BAY86-4875) is the first listed.

NCT01890421 names 20 study sites across 8 states, led by Other, Baden-Wurttemberg, North Rhine-Westphalia.

Frequently Asked Questions

What is clinical trial NCT01890421 about?

NCT01890421 is a clinical study titled "Gadobutrol/Gadavist-enhanced Cardiac Magnetic Resonance Imaging (CMRI) to Detect Coronary Artery Disease (CAD)". Participants being evaluated for suspected or known Coronary artery Disease (CAD) based on signs and/or symptoms, will be invited to participate in the study. The duration for a participant in the study may range from 2 days to 4-6 weeks. One to four visits to the study doctor will be required. Thi...

What is the current status of trial NCT01890421?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 426 participants. The study started on 2013-07-19. Estimated completion is 2017-08-31.

What conditions does trial NCT01890421 study?

This clinical trial studies the following conditions: Coronary Artery Disease.

What interventions are being tested in trial NCT01890421?

The interventions under investigation include: Gadobutrol (Gadovist, Gadavist, BAY86-4875) (DRUG).

Who is sponsoring clinical trial NCT01890421?

This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01890421 being conducted?

This trial has 20 study locations across Minnesota, Baden-Wurttemberg, Hesse, Lower Saxony, North Rhine-Westphalia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Coronary Artery Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01890421's enrollment target sits among peer trials

426 84th of 219 higher than 136 of 219 other Coronary Artery Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Coronary Artery Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT01890421, the US trial registry maintained by the National Library of Medicine. NCT01890421 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.