Myocardial perfusion with an intravascular contrast agent
| ISRCTN | ISRCTN53688797 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53688797 |
| Secondary identifying numbers | 25/11/2008 Final_v1.1 |
- Submission date
- 03/04/2009
- Registration date
- 13/11/2009
- Last edited
- 14/06/2013
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Eike Nagel
Scientific
Scientific
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
Study information
| 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 |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Quantitative assessment of myocardial perfusion with magnetic resonance using an intravascular contrast agent: an open label trial |
| Study objectives | 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) |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 28/02/2010 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 156 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 15/04/2009 |
| Date of final enrolment | 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
SE1 7EH
United Kingdom
Sponsor information
King's College London (UK)
University/education
University/education
The Rayne Institute
4th Floor Lambeth Wing
St Thomas' Hospital
London
SE1 7EH
England
United Kingdom
| Website | http://www.kcl.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
Industry
Bayer Schering Pharma AG (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
