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NCT01890434 · 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
478
Enrollment target
20
Study locations

NCT01890434 is a Phase 3 study of Coronary Artery Disease that has completed, run by Bayer. The registered enrollment target is 478 participants, below the 1,285-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (63% lower). The trial reports 20 study locations across 17 states.

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The verdict

NCT01890434, a Phase 3 study of Coronary Artery Disease, has completed, sponsored by Bayer.

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

Study Summary

Subjects 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 subject in the study may range from 2 days to 4-6 weeks. One to four visits to the study doctor will be required. The primary objective of this study is to demonstrate that sensitivity and specificity of gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) exceed pre-specified minimum performance thresholds of 60% and 55%, respectively, and to show superior sensitivity over unenhanced wall motion CMRI at vasodilator rest/stress for the detection of significant CAD. The CMR images acquired with a uniform imaging acquisition software will be evaluated either against the results from routine clinical Coronary Angiography (CA) or Computed Tomography Angiography (CTA), which are the standard of reference. CMRI and CA/CTA images will be collected for an independent image review (blinded read).

Conditions Studied

Coronary Artery Disease

Interventions

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

Study Locations (20)

Maryland

  • - Bethesda
  • - Bethesda

Ohio

  • - Cleveland
  • - Columbus

Other

  • - Chermside
  • - North Adelaide

Arizona

  • - Tucson

California

  • - Los Angeles

Georgia

  • - Atlanta

Illinois

  • - Chicago

Massachusetts

  • - Boston

Trial Details

FieldValue
Enrollment Target 478 participants
Start Date 2013-08-26
Est. Completion 2016-11-10
Phase Phase 3

Sponsor

Bayer

591 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01890434

The ClinicalTrials.gov registry entry for NCT01890434 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 478 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,285-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (63% lower). The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.

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

NCT01890434 reports 20 study locations spanning 17 distinct geographic areas - top geographies include Maryland, Ohio, Other.

Frequently Asked Questions

What is clinical trial NCT01890434 about?

NCT01890434 is a clinical study titled "Gadobutrol / Gadavist-enhanced Cardiac Magnetic Resonance Imaging (CMRI) to Detect Coronary Artery Disease (CAD)". Subjects 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 subject in the study may range from 2 days to 4-6 weeks. One to four visits to the study doctor will be required. The primary...

What is the current status of trial NCT01890434?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 478 participants. The study started on 2013-08-26. Estimated completion is 2016-11-10.

What conditions does trial NCT01890434 study?

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

What interventions are being tested in trial NCT01890434?

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

Who is sponsoring clinical trial NCT01890434?

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

Where is trial NCT01890434 being conducted?

This trial has 20 study locations across Arizona, California, Georgia, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.