The main goal of this study is to assess the diagnostic performance of Dual Energy CT in the detection of acute and chronic myocardial infarctions using MRI as a reference standard. The diagnostic performance of Dual Energy CT will be also assessed…
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Assessment of the presence of myocardial infarction per coronary distribution
on Dual Energy CT images, using MR as the reference standard.
Secondary outcome
assessment of the presence of no-reflow areas per coronary distribution on Dual
Energy CT images, using MR as the reference standard
visual-semiquantitative analysis of scar tissue
manual planimetry for the quantification of the scar tissue
Background summary
In patients with coronary artery disease (CAD), myocardial dysfunction due to
acute or chronic myocardial infarction may remain viable and may be restored
with revascularization. The identification of the viable myocardium has
important clinical and prognostic implications on the outcome of patients with
CAD. Magnetic Resonance Imaging (MRI) is considered the standard of reference
in the detection of myocardial scarring in both acute and chronic infarctions.
Thanks to several technical developments, cardiac Computed Tomography (CT) with
Dual Energy technique can be used not only for the detection of coronary artery
stenoses but also for the study of the myocardium.
We hypothesize that Dual Energy CT can accurately detect and quantify areas of
myocardial scarring in patients with acute and chronic infarctions. Patients
who are not suitable for MRI imaging due to contraindications (e.g. patients
with defibrillators and pacemakers) could be investigated with cardiac Dual
energy CT for the evaluation of myocardial viability.
Study objective
The main goal of this study is to assess the diagnostic performance of Dual
Energy CT in the detection of acute and chronic myocardial infarctions using
MRI as a reference standard. The diagnostic performance of Dual Energy CT will
be also assessed for the detection of no-reflow areas using MRI as reference of
standard.
Study design
Prospective diagnostic accuracy trial. Patients with either acute or chronic
myocardial infarction will undergo both cardiac Dual Energy CT and MRI. In
addition to the standard CT coronary angiography for the evaluation of the
lumen of the coronary arteries, an extra delayed scan with Dual Energy mode
will be performed for the evaluation of the myocardium. After the CT
examination, the patients will be examined with MRI.
Study burden and risks
Nature and extend of the burden and risk associated with participation, benefit
and group relatedness:
Cardiac CT is associated with radiation exposure to the patient. The patient
will be scanned twice in this research protocol: to evaluate first pass
perfusion and no-reflow (arterial phase, scan 1), and delayed enhancement (late
phase, scan 2). However, several radiation reduction techniques will be applied
to minimize radiation exposure.
The results of this study are one step in improving the diagnosis and
monitoring of persons with cardiac infarction.
Dr. Molewaterplein 40
3015 GD
NL
Dr. Molewaterplein 40
3015 GD
NL
Listed location countries
Age
Inclusion criteria
Patients with acute myocardial infarction
- Age>40 years
- Onset of symptoms no more than 14 days before CT and MRI;If Acute no ST-elevation myocardial infarction (NSTEMI)
- Clinical presentation: rest angina/ new-onset severe angina/ increasing angina
- ST segment depression >=0.05mV or inverted T waves >=0.2mV
- Detection of troponine T or CK elevation over a period of 24-48 hours
- Imaging evidence of new loss of viable myocardium or new regional wall motion abnormalities;Patients with chronic myocardial infarction
- Age>40 years
- Impaired left ventricle ejection fraction
- Regional myocardial dysfunction
Exclusion criteria
Clinical contraindications:
- Ongoing ischemia
- Relevant arrhythmias
- Coronary artery by-pass graft (CABG)
- Impaired renal function (serum creatinine>120 *mol/l or GFR<60 ml/min)
- Hemodynamic instability
- Possible pregnancy and breast feeding
- Body weight exceeding 120 kg
- Inability to breath hold for up 15 seconds
Contraindications for CT coronary angiography, including:
- Known allergy to iodated contrast material
Contraindications for MRI, including:
- MR incompatible metal in the body (pacemaker, metal implants, cerebral aneurysm clips, *)
- Severe claustrophobia
- Known allergy to gadolinium-based contrast material
Design
Recruitment
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 | NL33466.078.10 |