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| ID | Type | Description | Link |
|---|---|---|---|
| ISRCTN23698917 |
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Magnetic Resonance Imaging (MRI) is an effective and radiation free method of diagnosing Congenital Heart Disease (CHD). MRI works by taking images of the anatomy and physiology. These images also provide information on the hearts function and blood flow. The clarity of these images is enhanced by the use of contrast agents (dyes). However these agents only stay in the blood vessels for a short time and therefore limit the time in which the better quality images can be obtained. This study aims to determine whether MRI using Vasovist (a dye that stays in the vessels for a prolonged period of time) can improve the diagnosis of Congenital Heart Disease (CHD) by allowing more areas to be imaged and the improved assessment of various parameters (anatomy, volumes, flow) as well as vastly improving image quality.
We planned an intra-individual study, where 20 adult patients with CHD (e.g. Fallot Tetralogy, s/p corrective surgery, single ventricle s/p Fontan operation, aortic and pulmonary artery stenosis) will undergo two examinations. Both scans are aimed to assess different diagnostic parameter like angiography, cardiac anatomy, ventricular volume and flow.
The first clinically indicated scan in our clinically established imaging protocol is performed using a standard contrast agent. The second scan is performed using a new protocol with Vasovist within the next seven days. Informed consent for the additional second scan will be obtained. In order to optimise the scan protocol for Vasovist we plan a pilot phase using three patients. Dosage of the two contrast agents will be within the approved dose. Any adverse events will be immediately reported. The following diagnostic parameters will be assessed and compared between standard Gadolinium (Gd) agent and Vasovist.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vasovist | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The improvement of diagnosis of CHD, due to larger coverage of vascular territories, higher spatial resolution, faster acquisition and higher quality of MR-flow measurements using Vasovist in comparison with standard Gd-agent | ||
| The improvement of image quality will be analysed by measuring the SNR, the CNR, the vessel sharpness. In addition, the overall image quality will be scored by three independent readers (scale: excellent, good, ok, bad) | ||
| Ventricular volumes measured from the acquired data will be compared with respect to a reference | ||
| The accuracy (standard deviation) and reproducibility of the flow measurements will be compared using the two different agents |
| Measure | Description | Time Frame |
|---|---|---|
| No secondary outcome measures. |
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Inclusion Criteria:
The main inclusion criteria will be patient with CHD, i.e. complex congenital defects such as:
Exclusion Criteria:
The study will involve MR contrast agents and and MRI scans, therefore the principle exclusion criteria are:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reza Razavi, MD | Contact | 020-7188-5440 | 85440 | reza.razavi@kcl.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Imaging Sciences | Recruiting | London | SE1 7EH | United Kingdom |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| ID | Term |
|---|---|
| C109932 | gadofosveset trisodium |
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| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |