Assessment of myocardial viability in MRI: Comparison of Late Gadolinium Enhancement with Gadovist vs. Magnevist vs. Dotarem - Cardiac LGE

Phase 1

• Conditions: Patients with a history of chronic myocardial infarction; MedDRA version: 12.1Level: LLTClassification code 10028596Term: Myocardial infarction; MedDRA version: 12.1Level: LLTClassification code 10028598Term: Myocardial infarction old; MedDRA version: 12.1Level: LLTClassification code 10028599Term: Myocardial infarction old healed; MedDRA version: 12.1Level: LLTClassification code 10030272Term: Old myocardial infarction

• Registration Number: EUCTR2009-017739-17-DE
• Lead Sponsor: Charité

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-01-04
• Study Completion: 2010-10-09
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1.Adult patients, age 18 years and older
2.History of chronic myocardial infarction (echocardiography or ECG)
3.Willing to undergo and to comply with all study procedures
4.Written informed consent, self-signed and dated, voluntarily given
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients
1.who are female of childbearing potential or in nursery
2.with moderate impaired renal function (GFR calculated with MDRD formula =60 mL/min/1.72m2). Serum creatinine values must not be older than 12 weeks
3.with renal transplant, including patients with scheduled renal transplantation
4.with a contraindication to MRI (e.g. pacemaker, clips, severe claustrophobia)
5.with known allergy or any contraindication to Gadovist, Magnevist and/or Dotarem
6.presenting with a history of anaphylactoid or anaphylactic reaction to any of the ingredients of the study drugs.
7.having any physical or mental status interfering with the informed consent procedure including self-signed informed consent
8.being unstable or requiring emergency treatment
9.with close affiliation with the investigational site; e.g. a close relative of the investigator
10.who have received any contrast agent within 24 hours prior to entering this study
11.who are scheduled for any therapy between any of the study procedures that may interfere with the comparability of the study procedures
12.having an underlying disease or concomitant medication which may interfere with efficacy evaluation.
13.participating in another clinical trial
14.who have previously entered this study
15. with severe cardiovascular disease (e.g. congenital or family history of QT syndrome)
16. who are for legal or regulatory reasons hospitilized in an institution

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To gain first data on the comparison of Gadovist® with Magnevist® and Dotarem® with regard to the degree of late gadolinium enhancement (LGE) in infarcted myocardium;Secondary Objective: •To assess SNR and CNR of Late Gadolinium enhancement (LGE) until 45 minutes after injection of contrast media<br>•To assess the kinetic behaviour of LGE over 45 minutes after contrast agent injection;Primary end point(s): Infarct size on LGE images expressed as percentage of total left ventricular myocardial mass (Gadovist® vs. Magnevist® vs. Dotarem®)