Condition category
Circulatory System
Date applied
03/04/2009
Date assigned
13/11/2009
Last edited
14/06/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Eike Nagel

ORCID ID

Contact details

The Rayne Institute - Division of Imaging Sciences
School of Medicine - King's College London
4th Floor
Lambeth Wing
St. Thomas’ Hospital
London
SE1 7EH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

25/11/2008 Final_v1.1

Study information

Scientific title

Quantitative assessment of myocardial perfusion with magnetic resonance using an intravascular contrast agent: an open label trial

Acronym

Study hypothesis

The primary objective of the trial will be to develop and evaluate new methods for the true quantitative measurement of blood supply to the heart using cardiac magnetic resonance (MR) and gadolinium-based MR contrast agents.

The secondary objectives of the trial will be:
1. To optimise the MR sequence parameters for the acquisition of MR first pass perfusion images
2. To determine the best dosage and scheme of administration for the intravascular MR contrast agent Vasovist®
3. To compare the results obtained with different types of contrast agents and different MR sequences
4. To validate the newly developed methods for quantitative measurement of myocardial perfusion against 13N-Ammonia positron emission tomography (PET) and with fractional flow reserve (FFR)
5. To test the reproducibility of the different MR approaches to quantitative myocardial perfusion assessment

Ethics approval

NHS National Research Ethics Service - Guy's Research Ethics Committee approved on the 29th February 2009 (ref: 08/H0804/95; Protocol v.1.1)

Study design

Non-randomised non-controlled open label trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Coronary artery disease

Intervention

14/06/2013: Please note that this trial was stopped in April 2011.

First pass perfusion magnetic resonance during stress with intravenous (i.v.) adenosine.

Intervention type

Drug

Phase

Not Applicable

Drug names

Adenosine, Vasovist®

Primary outcome measures

1. Comparison and validation of Vasovist® perfusion MR versus conventional perfusion MR, PET and FFR:
1.1. Comparison between standard clinical qualitative evaluation of MR perfusion and fully quantitative evaluation
1.2. Validation against 13N-Ammonia PET (research indication) and/or FFR (only performed following a clinical indication as part of routine clinical care)
2. Reproducibility of Vasovist® first pass MR perfusion: comparison of the results between different perfusion MR scans

Secondary outcome measures

1. MR sequence optimisation for Vasovist® perfusion:
1.1. Signal to noise ratio in the images acquired with different MR techniques
1.2. Prevalence of artefacts in the images
2. Vasovist® dose selection:
2.1. Saturation effect of the peak contrast agent signal in the myocardium
2.2. Signal to noise ratio
2.3. Prevalence of artefacts in the images

Overall trial start date

15/04/2009

Overall trial end date

28/02/2010

Reason abandoned

Participant recruitment issue

Eligibility

Participant inclusion criteria

1. Known coronary artery disease (with or without prior percutaneous revascularisation)
2. Indication for percutaneous coronary intervention (PCI)
3. The subject is 18 years of age or older, either sex
4. The subject is conscious and able to comply with study procedures
5. Written informed consent has been obtained

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

156

Participant exclusion criteria

1. Contraindications for magnetic resonance imaging (MRI)
2. Contraindications to gadolinium-based contrast agents (known allergies or a contra-indication to gadolinium (Gd) chelates or renal insufficiency)
3. Contraindications to adenosine stress:
3.1. Myocardial infarction less than 3 days
3.2. Unstable angina pectoris
3.3. Severe arterial hypertension
3.4. Asthma or severe obstructive pulmonary disease requiring treatment (chronic obstructive pulmonary disease [COPD])
3.5. Sick sinus syndrome or a symptomatic bradycardia, atrioventricular (AV) block greater than IIa, trifascicular block
3.6. Allergy against vasodilator
3.7. Allergy against gadolinium-based contrast agents or renal insufficiency
3.8. Other contraindications for adenosine or dipyridamole administration
4. The subject has significant cardiac arrhythmia (i.e. atrial fibrillation)
5. Pregnancy
6. Heart failure (New York Heart Association [NYHA] grade IV)
7. The subject's electrocardiogram (ECG) shows prolonged QT interval
8. Severe arterial hypotension (less than 90 mmHg systolic)
9. Claustrophobia

Recruitment start date

15/04/2009

Recruitment end date

28/02/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Rayne Institute - Division of Imaging Sciences
London
SE1 7EH
United Kingdom

Sponsor information

Organisation

King's College London (UK)

Sponsor details

The Rayne Institute
4th Floor Lambeth Wing
St Thomas' Hospital
London
SE1 7EH
United Kingdom

Sponsor type

University/education

Website

http://www.kcl.ac.uk/

Funders

Funder type

Industry

Funder name

Bayer Schering Pharma AG (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes