Myocardial perfusion with an intravascular contrast agent

Completed

• Conditions: Coronary artery disease; Circulatory System; Chronic ischaemic heart disease

• Registration Number: ISRCTN53688797
• Lead Sponsor: King's College London (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-13
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 156

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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