To determine the feasibility of late enhancement imaging in spectral photon counting CT to detect myocardial infarction and viability
ID
Source
Brief title
Condition
- Myocardial disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Detection of MI using spectral photon counting late enhancement
(iodine/gadolinium) CT (extent, mass, percentage of left ventricle,
transmurality)
Secondary outcome
• Correlation of infarct size measurement on CMR versus CT
• Assessment of myocardial viability CMR versus CT
• Assessment of kidney function after dual contrast infusion (eGFR/MDRD)
• Detection of MI and CAD in a single CT scan
Background summary
Delayed enhancement cardiovascular magnetic resonance imaging (CMR) using
Gadolinium contrast media (CM) is the gold standard to detect myocardial
infarction and to assess myocardial viability non-invasively. Cardiac computed
tomography angiography (CCTA) using iodinated CM is the current non-invasive
standard to assess the presence and severity of anatomical coronary artery
disease (CAD). It is hypothesized that advances in CCTA technology will allow
physicians to assess CAD, myocardial infarction and viability in a single
investigation, by using the benefits and differences in dynamics/kinetics of
two commonly used CM (Gadolinium and iodine).
Study objective
To determine the feasibility of late enhancement imaging in spectral photon
counting CT to detect myocardial infarction and viability
Study design
Prospective single center feasibility study
Study burden and risks
Present study investigates the benefits of using Gadolinium and iodinated CM
right after each other to answer different clinical questions in a single
investigation. In present daily clinical routine, these questions are answered
by using both a CT and MRI scan. Ultimately, our approach intends to reduce
patient discomfort, health care costs and improve patient care. The benefit of
using Gadolinium and iodinated CM will be assessed in a step-wise approach.
Step 1. All participants will undergo a (clinically indicated) CMR scan (with
Gadolinium). Immediately after the CMR scan (<15 minutes), all patients will
undergo a CCTA examination (on a photon counting system) without additional CM
(note that Gadolinium contrast from CMR scan will be still present) Step 2.
After 1-4 weeks patients will be randomized in a 1:1 fashion to: - An
additional CCTA scan (on a photon counting system) with Iodine contrast
infusion only, or; - An additional CCTA scan (on a photon counting system) with
both Gadolinium and Iodine contrast infusion. Estimated radiation dose with
this high-end CT system is expected to be low (accumulated dose of both scans
in total <10 mSv). This study design including randomization of patients for
the 2nd CT-scan, minimizes the exposure of patients to additional diagnostic
tests, ionizing radiation and CM, while it allows us to compare different
imaging techniques. No studies have been performed investigating the influence
on kidney function when both CM are injected in close proximity. Gadolinium and
iodinated CM have a hypothetical increased risk for respectively nephrogenic
systemic fibrosis (NSF) and contrast induced nephropathy (CIN). However, in
patients with a normal renal function this risk is negligible.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
- Myocardial infarction (chronic). The diagnosis myocardial infarction is based
on clinical judgement and guideline definitions, such as complaints compatible
with myocardial ischemia, ECG changes, cardiac troponin elevation.
- Wall motion abnormalities in >=2 adjacent segments (on echocardiography)
- Clinically referred for CMR (e.g. viability assessment)
- Age 18-80 years of age
Exclusion criteria
- Logistics: Inability to organize CT directly after CMR scan - Safety:
pregnancy or breast-feeding - Safety: contraindications to CMR or CT * Metallic
implant (vascular clip, neuro-stimulator, cochlear implant) * Pacemaker or
implantable cardiac defibrillator (ICD) * Claustrophobia * Body weight >130 kg
or BMI > 35 or body habitus that does not fit into the gantry *
Contraindications to betablockers of nitrates - Safety: Renal failure
(estimated Glomerular Filtration Rate (eGFR) <60 mL/min/1,73m2) - Safety: known
moderate-severe allergy to Gadolinium or iodine contrast agents - Irregular
heart rhythm (i.e. atrial fibrillation, frequent extrasystole) - Considered not
eligible by treating physician
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL83656.068.23 |