No registrations found.
ID
Source
Brief title
Health condition
Coronary artery disease/ coronaire hartziekte
Dual energy CT
Perfusion imaging/ Perfusie beeldvorming
Sponsors and support
Intervention
Outcome measures
Primary outcome
The diagnostic accuracy of the rest coronary CT angiography in combination with stress dual energy CT in comparison to SPECT and invasive coronary angiography in patients with a intermediate to high risk of coronary artery disease.
Secondary outcome
Diagnostic accuracy of myocardial ischemia detection using DECT in comparison to SPECT ischemia detection in patients with a intermediate to high risk of coronary artery disease, radiation dose.
Background summary
The purpose of this study is to validate a comprehensive CT protocol to determine hemodynamically significant coronary artery disease. Combined DECT and CT angiography could provide a one-stop shop in cardiac imaging in the future. The diagnostic accuracy of DECT plus CT angiography will be determined in comparison to gold standard, SPECT and ICA. This proposal will provide crucial data evaluating this potential. The disadvantages of this study are the radiation dose and the administration of contrast agents and beta-blocker. In accordance with limited reports so far, we determined that the radiation burden for comprehensive cardiac CT imaging will not exceed 10 mSv for each individual patient, which can be checked real time during the CT examination. Because of the administration of contrast agent, patients with a poor renal function (eGFR< 50 ml/min) and iodine allergy will be excluded. Patients with healthy renal function are not expected to have negative effects due to the contrast administration. The scans will be made on a third generation dual source scanner (Force, Siemens Medical Systems, Forchheim, Germany).
Study objective
The aim of this study is to validate a new CT technique (dual energy CT) in the ability to detect myocardial perfusion defects in patients suspected of having coronary artery disease. A combination of CT angiography and stress dual energy will be compared to gold standard diagnosis, SPECT and invasive coronary angiography.
Study design
Not applicable
Intervention
Dual energy CT scan and CT angiography
Dept of Radiology<br>
University of Groningen / University Medical Center Groningen
R. Vliegenthart
Groningen
The Netherlands
r.vliegenthart@umcg.nl
Dept of Radiology<br>
University of Groningen / University Medical Center Groningen
R. Vliegenthart
Groningen
The Netherlands
r.vliegenthart@umcg.nl
Inclusion criteria
• Stable angina pectoris
• Nuclear MPI within the last 60 days
• Scheduled for ICA
• Patients must provide consent in writing after proper education and discussion with the treating physician and/or research physician
• 50 years or older
Exclusion criteria
• Cardiac rhythm other than sinus
• Second or third degree atrioventricular block
• Prolonged QT-time
• Sick-sinus syndrome
• Asthma or chronic obstructive pulmonary disease
• Contraindications for iodine contrast
• Thyroid gland disorders
• Renal insufficiency (eGFR < 50 ml/min)
• Rest heart > 65 bpm and contraindications for beta-blocker
• Severe arterial hypertension (>220/120 mmHg)
• Severe arterial hypotension (<80/40 mmHg)
• Unable to stay in a supine position
• Morbidly obese (Body mass index >35)
• Severe physical deterioration due to concomitant illness
• Language barrier
• Acute coronary syndrome
• Pregnancy
• Claustrophobia
• Using of persantin, theophylline, digoxin or verapamil, if temporarily stopping (48h) is not possible
• Contraindications for CTA: presence of pacemaker or ICD leads, AF, pregnancy, BMI >35 kg/m2, prosthetic heart valve
• Previously documented myocardial infarction/PCI/CABG
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 |
|---|---|
| NTR-new | NL5634 |
| NTR-old | NTR5749 |
| Other | : ABR 53631 |