Ischemic cardiomyopathy, with inducible ischemia and clinical indication to cardiac revascularization MedDRA version: 9.1 Level: LLT Classification code 10055217 Term: Ischemic cardiomyopathy
Conditions
Interventions
Trade Name: VASOVIST 0.25 mmol/ml, solution for injection
Pharmaceutical Form: Solution for injection
INN or Proposed INN: gadofosveset trisodium
Concentration unit: mmol/ml millimole(s)/millilitre
Co
Sponsors
King's College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients referred for MR adenosine stress perfusion, with or without known coronary artery disease, with or without prior myocardial revascularization The subject is =18 years of age The subject is conscious and able to comply with the study procedures Written informed consent has been obtained Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Contraindications for MRI Contraindications to Gadolinium based contrast agents (known allergies or a contra indication to Gd chelates or renal insufficiency) Contraindications to Adenosine stress • Myocardial infarction IIa, trifascicular block • Allergy against vasodilator • Allergy against Gadolinium based contrast agents or renal insufficiency • Other contraindications for adenosine or dipyridamole administration Pregnancy Heart failure (NYHA IV) The subject’s ECG shows prolonged QT interval Severe arterial hypotension (< 90 mmHg systolic) Claustrophobia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. All the types of contrast agent used in this study are already in use for human cardiovascular applications.;Secondary Objective: Secondary objectives of the trial will be: - To optimize the MR sequence parameters for the acquisition of MR first pass perfusion images. - To determine the best dosage and scheme of administration for the intravascular MR contrast agent Vasovist. - To compare the results obtained with different types of contrast agents and different MR sequences. - To validate the newly developed methods for quantitative measurement of myocardial perfusion against 13N-Ammonia Positron Emission Tomography (PET), which is considered the gold standard for the non-invasive measurement of myocardial perfusion and, when clinically indicated and performed, with Fractional Flow Reserve (FFR), which is currently considered the invasive gold standard for invasive measurement of myocardial perfusion. - To test the reproducibility of the different MR approaches to quantitative myocardial perfusion assessment ;Primary end point(s): Endpoints of the study in each of the experimental phases will be (see protocol): - Phase 1 Signal to noise ratio in the images acquired with different MR techniques Prevalence of artefacts in the images - Phase 2 Saturation effect of the peak contrast agent signal in the myocardium Signal to noise ratio Prevalence of artefacts in the images - Phase 3 Comparison between standard clinical qualitative evaluation of MR perfusion and fully quantitative evaluation Validation against 13N-Ammonia PET (research indication) and/or FFR (only performed following a clinical indication as part of routine clinical care) - Phase 4 Comparison of the results between different perfusion MR scans | — |
Countries
United Kingdom
Outcome results
None listed