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

NCT00668824 | Unknown Phase 4

• 2 other identifiers: 07/Q0704/2ISRCTN23698917
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Congenital Heart Disease

Keywords

Congenital Heart Disease (CHD)

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• No secondary outcome measures.

Interventions

Vasovist DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aortic abnormalities
• Pulmonary artery abnormalities
• Systemic or pulmonary venous abnormalities
• The study will be limited to patients aged 18 and over

You may not qualify if:

• Any contra-indications to MR (e.g. pacemakers)
• Known allergy to MR contrast agents
• Patients not agreeing to take part in study
• Pregnancy and nursing mothers

Sponsors & Collaborators

• Guy's Hospital: lead

Study Sites (1)

Division of Imaging Sciences

London, SE1 7EH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

gadofosveset trisodium

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Reza Razavi, MD

CONTACT

020-7188-5440; reza.razavi@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 4
• Purpose: DIAGNOSTIC
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 24, 2008
• First Posted: April 29, 2008
• Study Start: March 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: December 1, 2009
• Last Updated: August 3, 2009

Record last verified: 2009-07

Locations

GB (1)