Additional identifiers
EudraCT/CTIS number
IRAS 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(s)
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
Study setting(s)
Hospital
Study 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
Pharmaceutical study type(s)
Phase
Not Applicable
Drug/device/biological/vaccine name(s)
Adenosine, Vasovist®
Primary outcome measure
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 study start date
15/04/2009
Overall study end date
28/02/2010
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
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
England, United Kingdom
Study 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
England
United Kingdom
Sponsor type
University/education
Website
ROR
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |