Comparison of Gadobutrol and Gadobenate Dimeglumin for De... | NCT01655290

Studies
Comparison of Gadobutrol and Gadobenate Dimeglumin for Delayed Enhancement Cardiac MRI

NCT01655290

Sponsor

Technical University of Munich

Status

Completed

Last Update Posted

Oct 22, 2020Actual

Enrollment

20Actual

Phase

Phase 2

Conditions

Subacute/Chronic Myocardial Infarction

Interventions

Gadovist® (Gadobutrol), Multihance® (Gadobenate dimeglumin)

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2012

Primary Completion Date

May 2013Actual

Completion Date

Jun 2014Actual

First Submitted Date

Jul 30, 2012

First Submission Date that Met QC Criteria

Jul 30, 2012

First Posted Date

Aug 1, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 20, 2020

Last Update Posted Date

Oct 22, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims at evaluating the diagnostic efficacy of Gadobutrol versus Gadobenate dimeglumine at similar dose of 0.1mmol/kg for assessment of myocardial infarction by delayed enhancement cardiac Magnetic Resonance Imaging

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gadobutrol	Experimental	first session gadobutrol second session gadobenate dimeglumin	Other: Gadovist® (Gadobutrol), Multihance® (Gadobenate dimeglumin)
Demeglumin	Experimental	first session gadobenate dimeglumin second session gadobutrol	Other: Gadovist® (Gadobutrol), Multihance® (Gadobenate dimeglumin)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gadovist® (Gadobutrol), Multihance® (Gadobenate dimeglumin)	Other	Other (Diagnostic)	Demeglumin Gadobutrol

Measure	Description	Time Frame
Efficacy (contrast-to-noise ratio)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of myocardial infarction
Age ≥ 18 years and ≤ 80 years
Informed consent
Male patients as well as female patients using contraceptives

Exclusion Criteria:

Patients with a heart pacemaker, with magnetic material or other magnetic implants.
Renal failure (GFR <30ml/min)
Patients with known allergy to a Gadolinium-containing contrast agent
Drugs or alcohol addiction, dementia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institut für Radiologie - Klinikum Rechts der Isar		Munich	Bavaria	81675	Germany

Intervention Browse Module

MeSH Terms

ID	Term
C090600	gadobutrol
C064572	gadobenic acid

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided