E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10060963 |
E.1.2 | Term | Arterial disorder |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To attempt to optimise contrast enhanced magnetic resonance imaging of patients with carotid artery narrowing and aiding assessment of risk of stroke in these patients. |
|
E.2.2 | Secondary objectives of the trial |
To establish if contrast enhanced magnetic resonance imaging using a stronger magnetic field (at 3 Tesla) superior to the more commonly used clinical magnetic field of 1.5T. To demonstrate if contrast enhanced sequences that image the carotid artery at 1.5T and 3.0T show adequate repeatability. Optimisation of contrast enhanced signal characteristics at 1.5T and 3.0T using different surface coil arrays. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Carotid stenosis of >40% diagnosed on carotid ultrasound or angiogram.
2. Male or female aged 18 to 90 years of age. Female subjects must be of non−childbearing potential (post−menopausal females who have been amenorrhoeic for more than one year, or pre−menopausal females with a documented hysterectomy or bilateral oophorectomy). |
|
E.4 | Principal exclusion criteria |
Contraindication to MR imaging including but not limited to: a) intracranial aneurysm clips (except Sugita) with an appropriate operative conformation b) history of intra− orbital metal fragments that have not been removed by an medical doctor, pacemakers and non−MR compatible heart valves c) inner ear implants d) history of claustrophobia in MR e) Participation in more than 2 clinical studies at any one time
Other contraindications: 1. Known renal impairment 2. Previous renal or liver transplant 3. History of clinically significant atopy (e.g. anaphylaxis, skin rash to medication or topical therapies, hypersensitivity to iodinated contrasts, gadolinium based compunds, allergies to food (e.g. shellfish), bronchial asthma, etc.) 4. Inability to give informed consent |
|
E.5 End points |
E.5.1 | Primary end point(s) |
When the 100th patient has been images and the data analysis is complete. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Once the 100th patient is imaged and the data analysis is complete the trial will be ended. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |