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Gadolinium

Phase 2/3

Heart Disease, Ischemic | Small molecule | Cardiovascular |Bayer AG|Trials Updated: Sep 26, 2014

Gadolinium development status

Highest phase Phase 2/3 (NCT01234870)
Phase scored for BAYRYPhase 2
Registered trials 3 across 3 sponsors since Sep 2017

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Gadolinium clinical trials

Gadolinium · 1 trial · 2 indications

Phase 2/3 1
NCT01234870Comprehensive Evaluation of Ischemic Heart Disease Using MRIHeart Disease, Ischemic
COMPLETED40 Analytics
PHASE2/PHASE3COMPLETED
Comprehensive Evaluation of Ischemic Heart Disease Using MRI
Heart Disease, IschemicUnlock trial analytics

Study Endpoints

Primary Endpoints

Magnetic Resonance Image Quality Rating
Cross sectional study; magnetic resonance images were obtained on all patients using two different acquisition methods.

The purpose of the study is to assess the incremental value of diagnostic performance using a fully-automated, motion-corrected (MC) first pass myocardial perfusion image acquisition protocol compared to images obtained under a non-corrected, breath-hold, shallow-breathing first pass myocardial perfusion image acquisition protocol in patients with suspected ischemic heart disease. The MR images resulting from two different image acquisition techniques, including Non-Corrected Breath-Hold Shallow-Breathing and Motion-Corrected, were assessed independently by two radiologists (average of 7 years of experience in reading cardiac MRI) using the American Heart Association modified 16 segment model and were evaluated using a four point Likert scale (1 = poor, 2 = fair, 3 = good, and 4 = excellent) for image quality

Secondary Endpoints

Number of Participants With Adverse Events to Demonstrate Feasibility of a Comprehensive Cardiac Magnetic Resonance Imaging Protocol
14 days
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
Ischemic heart disease patientsEXPERIMENTALPatients with suspected ischemic heart disease prospectively recruited for first pass myocardial perfusion MRI. All subject to receive Gadolinium infusion of 0.075 mmol/kg at rate of 4 ml/sec. Adenosine administered at a rate of 0.14 mg/kg/min for a duration of 4 minutes to induce stress.

Interventions

NameTypeDescription
GadoliniumDRUG -
AdenosineDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: Under an Institutional Committee on Human Research board approved protocol 80 patients with a suspected myocardial ischemic disease recruited from the cardiac cath laboratory will be recruited in this prospective study. Volunteers will be recruited for the purpose of protocol de...

Countries:United States
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