E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003601 |
E.1.2 | Term | Atherosclerosis |
E.1.2 | System Organ Class | 100000004866 |
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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 demonstrate the uptake of Rienso in the vessel wall (defined as a decrease of T2 and T2* on MRI) in patients with cardiovascular disease. |
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E.2.2 | Secondary objectives of the trial |
- Correlation between the uptake of Rienso in the vessel wall and parameters of endothelial permeability (k-trans and AUC as measured by DCE-MRI).
- Correlation between the uptake of Rienso in the vessel wall and circulating markers of inflammation (e.g. CRP, LpPLA2).
- Correlation between the uptake of Rienso in the vessel wall and severity of cardiovascular disease.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients with established cardiovascular disease (one or more of the following)
- Coronary artery disease (e.g. myocardial infarction, angina pectoris, ischemic heart disease)
- Carotid artery disease, previous stroke or transient ischemic attack
- Aortic aneurysmatic disease
- Peripheral artery disease
Patients with an elevated cardiovascular risk (one or more of the following)
- BMI > 27
- Metabolic syndrome
- Diabetes mellitus type II
- Hypertension (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg)
- Reduced high-density lipoprotein
- Elevated low-density lipoprotein
Healthy volunteers
- Aged 40-80 years
- Not known with cardiovascular risk factors. |
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E.4 | Principal exclusion criteria |
Active inflammatory diseases
History of anaphylaxis or other hypersensitivity reactions
History of iron overload
History of renal failure
History of abnormal liver function, or elevated liver enzymes.
Claustrophobia
Metal-containing material in the body or attached to the body |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary study endpoint is the change in T2/T2* signal intensity in the vessel wall as measured by MRI after the administration of Rienso. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
A baseline MRI scan will be performed just before infusion of Rienso. Twenty-four hours after administration of Rienso, a repeat MRI scan will be performed. Thus, the change in T2/T2* signal intensity at the level of the vessel wall will be measured 24 hours after Rienso administration. |
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E.5.2 | Secondary end point(s) |
The relation between uptake of Rienso in the vessel wall (T2/T2* signal decrease on MRI) and parameters reflecting vessel wall leakage as measured by DCE-MRI (e.g. k-trans, area under the curve).
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
DCE-MRI parameters will be evaluated maximal three months before administration of Rienso. |
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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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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.8.5 | The trial involves multiple Member States | No |
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 | No |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |