An interventional study of standard protocol and enhanced protocol in Obesity, Morbid, sponsored by Cantonal Hospital of St. Gallen. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-17.
Sponsored by Cantonal Hospital of St. Gallen · Not applicable, Interventional, and Diagnostic
Coronary arterial disease is a risk factor for bariatric surgery and might be a predictor for later major adverse coronary events. Diagnosis of coronary arterial disease would thus be desirable for obese patients, however percutaneous angiography is an invasive procedure and associated with a certain morbidity in obese patients. In this study the investigators would like to assess whether dual source CT angiography can be used for diagnosis of coronary arterial disease in severely obese patients and which settings yield the best image quality.
Obesity is a major health problem in many countries and a major risk factor for cardiovascular disease. Extreme obesity can be treated with surgery, however these procedures are associated with a certain surgery-related morbidity which increases with comorbidities, in particular coronary diseases. Thus, preoperative cardiac risk assessment would be desirable, however percutaneous coronary angiography is an invasive procedure with problems and complications in obese patients. A non-invasive alternative would be coronary dual-.source CT angiography (CCTA), however little experience exists in the application of CCTA in morbid obese patients. This study would like to address the following issues:
922 studies on the registry are indexed under Obesity, Morbid; 172 are open to participants now.
This study's enrollment of 70 is above the median of 60 across 590 interventional studies indexed under Obesity, Morbid.
Browse Obesity, Morbid studies →Cantonal Hospital of St. Gallen is the lead sponsor of 79 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Standard dual-source computed tomography coronary angiography protocol
Radiation: standard protocol
enhanced dual-source computed tomography coronary angiography protocol
Radiation: enhanced protocol
enhanced obesity-mode dual-source computed tomography coronary angiography protocol
Radiation: enhanced obesity protocol
tube voltage: 120 kV current time product: 350 mAs/rotation rotation: 90° (with two detectors in a 90° angle)
Also known as: dual source computed tomography coronary angiography
tube voltage: 140 kV current time product: 350 mAs/rotation rotation: 90° (with two detectors in a 90° angle)
Also known as: dual source computed tomography coronary angiography
tube voltage: 140 kV current time product: 350 mAs/rotation rotation: 180° (with two detectors in a 90° angle)
Also known as: dual source computed tomography coronary angiography
Image quality
Coronary arteries (with at least 1 mm diameter at their origin) were segmented according to the 15-segment model of the American Heart Association (Austen 1975). Subjective image quality was judged for each coronary artery segment on a 4-point scale (Leschka 2007) : 1. = excellent; 2. = good, minor artifacts; 3. = fair, moderate artifacts but still diagnostic; 4. = non-diagnostic
Time frame: 7 days
coronary artery stenosis
Significant coronary artery stenosis was defined as more than 50% narrowing of luminal diameter. Stenosis assessment was performed by a radiologist not involved in image quality assessment.
Time frame: 7 days
Image noise
Image noise was determined as the standard deviation of the attenuation value in a region of 1 sq cm that was placed in the ascending aorta. The average of the attenuation in the left and right coronary artery were used for further calculations.
Time frame: 7 days
Signal-to-noise ratio (SNR)
SNR was determined by dividing mean attenuation by image noise
Time frame: 7 days
contrast-to-noise ratio (CNR)
Vessel contrast was calculated as the difference in the mean attenuation (in Hounsfield units) between the contrast-enhanced vessel lumen and the mean attenuation in the adjacent perivascular tissue. Attenuations were measured in a region in the proximal segment of the right coronary artery and in the left main artery, and were defined as large as possible, whereas avoiding calcifications and plaques. CNR was calculated as vessel contrast divided by image noise (Husmann 2006, Lembcke 2004).
Time frame: 7 days
Major adverse cardiovascular events (MACE)
Any of the following events: * death * non fatal myocardial infarction * late revascularization with percutaneous coronary intervention * coronary artery bypass grafting
Time frame: 7 years
Plan to share: No
This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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Cantonal Hospital of St. Gallen