Comparison of the performance of three contrast agents (Gadovist, Dotarem and Multihance) in magnetic resonance imaging (MRI) in volunteers and patients with narrowing or constriction of the inner surface of the carotid artery

Phase 1

• Conditions: Supraaortic vessel disease; suspicion or proven carotid artery stenosis / stenoses; MedDRA version: 13.1Level: PTClassification code 10007687Term: Carotid artery stenosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2010-021526-36-DE
• Lead Sponsor: Klinikum der Universität München

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-12-03
• Last Update Posted: 21 September 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Volunteer part:
1.age: at least 18 years
2.no history of cardiovascular disease
3.willing to undergo all study procedures
4.has voluntarily signed and dated the informed consent form
Women of childbearing potential:
5.a negative pregnancy test (urine test) on the day of contrast agent administration
6.use of a highly effective method of birth control during the duration of the study (e.g. implants, injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence or vasectomised partner)

Patient part:
1.age: at least 18 years
2.suspicion or proven carotid artery stenosis / stenoses
3.willing to undergo all study procedures
4.has voluntarily signed and dated the informed consent form
Women of childbearing potential:
5.a negative pregnancy test (urine test) on the day of contrast agent administration
6.use of a highly effective method of birth control during the duration of the study (e.g. implants, injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence or vasectomised partner)

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

Volunteer part:
1.if female:, pregnant or nursing
2.history of renal disease, subjects in the perioperative liver transplantation period and / or with acute or chronic severe renal impairment
3.GFR <60ml/m²/1.73m² (MDRD) as determined from a serum creatinine value not older than 4 weeks before MR contrast agent injection
4.contraindications against MR imaging (e.g. subjects with implanted ferromagnetic objects (pacemaker, vascular clip))
5.contraindications against any of the three MR contrast agents (e.g. aggravation of anaphylactic-like reactions in patients on beta-blockers, and particularly in the presence of bronchial asthma, low seizure threshold in patients with CNS disorders, patients with uncorrected hypokalemia, severe cardiovascular disease)
6.severe claustrophobia
7.history of anaphylactoid or anaphylactic reaction to any allergen (e.g. hay fever, urticaria, asthma, history of sensitivity to benzyl alcohol, etc.) including drugs and contrast agents
8.having received any investigational drug within 7 days prior to entering this study
9.planned to receive any investigational drug during the study period
10.close affiliation with the investigational site (e.g., close relative of an investigator)
11.participating in another clinical trial
12.having been previously enrolled in this clinical trial
13.any medical condition that potentially reduces cardiac output

Patient part:
1.if female:, pregnant or nursing
2.history of renal disease, subjects in the perioperative liver transplantation period and / or with acute or chronic severe renal impairment
3.GFR <30ml/m²/1.73m² (MDRD) as determined from a serum creatinine value not older than 4 weeks before MR contrast agent injection
4.contraindications against MR imaging (e.g. subjects with implanted ferromagnetic objects (pacemaker, vascular clip))
5.contraindications against any of the three MR contrast agents (e.g. aggravation of anaphylactic-like reactions in patients on beta-blockers, and particularly in the presence of bronchial asthma, low seizure threshold in patients with CNS disorders, patients with uncorrected hypokalemia, severe cardiovascular disease)
6.severe claustrophobia
7.history of anaphylactoid or anaphylactic reaction to any allergen (e.g. hay fever, urticaria, asthma, history of sensitivity to benzyl alcohol, etc.) including drugs and contrast agents
8.having received any investigational drug within 7 days prior to entering this study
9.planned to receive any investigational drug during the study period
10.close affiliation with the investigational site (e.g., close relative of an investigator)
11.participating in another clinical trial
12.having been previously enrolled in this clinical trial
13.any medical condition that potentially reduces cardiac output
14.prior carotid artery stenting on investigated body side

Study & Design

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