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Improved Diagnosis of Congenital Heart Disease by Magnetic Resonance Imaging Using Vasovist (CHD Vasovist)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by Guy's Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00668824
First Posted: April 29, 2008
Last Update Posted: August 3, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Guy's Hospital
  Purpose
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.

Condition Intervention Phase
Congenital Heart Disease Drug: Vasovist Phase 4

Study Type: Interventional
Study Design: Primary Purpose: Diagnostic
Official Title: Improved Diagnosis of Congenital Heart Disease by Magnetic Resonance Imaging Using Vasovist

Resource links provided by NLM:


Further study details as provided by Guy's Hospital:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • No secondary outcome measures.

Study Start Date: March 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  1. MR-Angiography (MRA): assessment of the MRA quality of the large systemic and the pulmonary vessel (arterial and venous) by measuring the Contrast-to-Noise Ratio (CNR) and the vessel sharpness. In addition, the overall image-quality will be scored by three independent readers (scale: excellent, good, ok, bad).
  2. Cardiac Anatomy: assessment of image quality of the cardiac anatomy from 3D single/dual phase MRI by measuring Signal-to-Noise Ratio (SNR) and CNR as well as assessing the overall image quality by three independent readers (scale: excellent, good, ok, bad).
  3. Ventricular Volumes: comparison of systolic and diastolic volumes measured from multi-slice 2D short axis cine MRI, two single phases 3D whole heart MRI (diastole and systole).
  4. Flow: the different flow values will be measured in the large vessels using the Phase Contrast Angio (PCA) data. Furthermore, the flow reproducibility will be determined by using two scans. The overall scan-time to assess all these parameter will be approximately 40 minutes. The intra-individual study allows a direct comparison of the different parameters in a number of vascular territories.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The main inclusion criteria will be patient with CHD, i.e. complex congenital defects such as:

    1. Aortic abnormalities
    2. Pulmonary artery abnormalities
    3. Systemic or pulmonary venous abnormalities
    4. The study will be limited to patients aged 18 and over

Exclusion Criteria:

  • The study will involve MR contrast agents and and MRI scans, therefore the principle exclusion criteria are:

    1. Any contra-indications to MR (e.g. pacemakers)
    2. Known allergy to MR contrast agents
    3. Patients not agreeing to take part in study
    4. Pregnancy and nursing mothers
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00668824


Contacts
Contact: Reza Razavi, MD 020-7188-5440 ext 85440 reza.razavi@kcl.ac.uk

Locations
United Kingdom
Division of Imaging Sciences Recruiting
London, United Kingdom, SE1 7EH
Contact: Reza Razavi, MD    020-7188-5440 ext 85440    reza.razavi@kcl.ac.uk   
Principal Investigator: Reza Razavi, MD         
Sponsors and Collaborators
Guy's Hospital
  More Information

Responsible Party: Jackie Pullen, King's College London
ClinicalTrials.gov Identifier: NCT00668824     History of Changes
Other Study ID Numbers: 07/Q0704/2
ISRCTN23698917
First Submitted: April 24, 2008
First Posted: April 29, 2008
Last Update Posted: August 3, 2009
Last Verified: July 2009

Keywords provided by Guy's Hospital:
Congenital Heart Disease (CHD)

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities