ECG Triggered Dual Source CT for Non-invasive Pre-operative Cardiac Imaging in Morbid Obese Patients
Primary Purpose
Obesity, Morbid
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
standard protocol
enhanced protocol
enhanced obesity protocol
Sponsored by
About this trial
This is an interventional diagnostic trial for Obesity, Morbid focused on measuring obesity, dual source CT, coronary CT angiography, prognosis, bariatric surgery, gastric bypass surgery, coronary arterial disease, major adverse coronary event
Eligibility Criteria
Inclusion Criteria:
- morbid obesity (BMI >35 kg/m²)
- intention to undergo bariatric surgery
- increased risk for coronary artery disease (based on PROCAM score)
Exclusion Criteria:
- kidney insufficiency (serum creatinine >100 µmol/l, creatinine clearance <50 ml/min)
- allergy to iodine containing contrast agents
- hyperthyroidism
- metformin medication
- pregnancy
Sites / Locations
- Cantonal Hospital St Gallen
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
A: standard protocol
B: enhanced protocol
C: enhanced obesity protocol
Arm Description
Standard dual-source computed tomography coronary angiography protocol
enhanced dual-source computed tomography coronary angiography protocol
enhanced obesity-mode dual-source computed tomography coronary angiography protocol
Outcomes
Primary Outcome Measures
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) :
= excellent;
= good, minor artifacts;
= fair, moderate artifacts but still diagnostic;
= non-diagnostic
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.
Secondary Outcome Measures
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.
Signal-to-noise ratio (SNR)
SNR was determined by dividing mean attenuation by image noise
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).
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
Full Information
NCT ID
NCT02802579
First Posted
June 14, 2016
Last Updated
June 16, 2016
Sponsor
Cantonal Hospital of St. Gallen
1. Study Identification
Unique Protocol Identification Number
NCT02802579
Brief Title
ECG Triggered Dual Source CT for Non-invasive Pre-operative Cardiac Imaging in Morbid Obese Patients
Official Title
ECG Triggered Dual Source CT for Non-invasive Pre-operative Cardiac Imaging in Morbid Obese Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cantonal Hospital of St. Gallen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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:
Comparison of image quality of coronary CT angiography using a dual source CT from obese patients using a special protocol (140 kV, 350 mAs) with images from historical controls from normal weight patients with a standard protocol (120 kV, 330 mAs).
Prediction of major adverse coronary events. Patients with a coronary stenosis in CCTA will be followed for any major adverse coronary events (details see Outcomes)
Is it possible to detect myocardial fat by a reduced CT density. Images from obese patients will be compared to historical controls from normal patients. Furthermore, is the myocardial CT density correlated with the BMI of obese patients?
Optimisation of scan protocol. Increasing the scanning angle beyond the standard 90° will reduce the signal noise at the cost of temporal resolution. Various scanning angles with be tested for an optimal combination of signal noise and temporal resolution.
Does the long QT-syndrome improve after bariatric surgery? It is assumed that the long QT-syndrome is a consequence of fattening of the myocardia. Is it possible to see a reduction of myocardial fattening and thus an improvement of the long QT-syndrome with CT during the follow-up after bariatric surgery?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid
Keywords
obesity, dual source CT, coronary CT angiography, prognosis, bariatric surgery, gastric bypass surgery, coronary arterial disease, major adverse coronary event
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A: standard protocol
Arm Type
Active Comparator
Arm Description
Standard dual-source computed tomography coronary angiography protocol
Arm Title
B: enhanced protocol
Arm Type
Experimental
Arm Description
enhanced dual-source computed tomography coronary angiography protocol
Arm Title
C: enhanced obesity protocol
Arm Type
Experimental
Arm Description
enhanced obesity-mode dual-source computed tomography coronary angiography protocol
Intervention Type
Radiation
Intervention Name(s)
standard protocol
Other Intervention Name(s)
dual source computed tomography coronary angiography
Intervention Description
tube voltage: 120 kV current time product: 350 mAs/rotation rotation: 90° (with two detectors in a 90° angle)
Intervention Type
Radiation
Intervention Name(s)
enhanced protocol
Other Intervention Name(s)
dual source computed tomography coronary angiography
Intervention Description
tube voltage: 140 kV current time product: 350 mAs/rotation rotation: 90° (with two detectors in a 90° angle)
Intervention Type
Radiation
Intervention Name(s)
enhanced obesity protocol
Other Intervention Name(s)
dual source computed tomography coronary angiography
Intervention Description
tube voltage: 140 kV current time product: 350 mAs/rotation rotation: 180° (with two detectors in a 90° angle)
Primary Outcome Measure Information:
Title
Image quality
Description
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) :
= excellent;
= good, minor artifacts;
= fair, moderate artifacts but still diagnostic;
= non-diagnostic
Time Frame
7 days
Title
coronary artery stenosis
Description
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
Secondary Outcome Measure Information:
Title
Image noise
Description
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
Title
Signal-to-noise ratio (SNR)
Description
SNR was determined by dividing mean attenuation by image noise
Time Frame
7 days
Title
contrast-to-noise ratio (CNR)
Description
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
Title
Major adverse cardiovascular events (MACE)
Description
Any of the following events:
death
non fatal myocardial infarction
late revascularization with percutaneous coronary intervention
coronary artery bypass grafting
Time Frame
7 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
morbid obesity (BMI >35 kg/m²)
intention to undergo bariatric surgery
increased risk for coronary artery disease (based on PROCAM score)
Exclusion Criteria:
kidney insufficiency (serum creatinine >100 µmol/l, creatinine clearance <50 ml/min)
allergy to iodine containing contrast agents
hyperthyroidism
metformin medication
pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastian Leschka, MD
Organizational Affiliation
Cantonal Hospital St. Gallen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cantonal Hospital St Gallen
City
St. Gallen
ZIP/Postal Code
9007
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
1116248
Citation
Austen WG, Edwards JE, Frye RL, Gensini GG, Gott VL, Griffith LS, McGoon DC, Murphy ML, Roe BB. A reporting system on patients evaluated for coronary artery disease. Report of the Ad Hoc Committee for Grading of Coronary Artery Disease, Council on Cardiovascular Surgery, American Heart Association. Circulation. 1975 Apr;51(4 Suppl):5-40. doi: 10.1161/01.cir.51.4.5. No abstract available.
Results Reference
background
PubMed Identifier
17620936
Citation
Leschka S, Scheffel H, Desbiolles L, Plass A, Gaemperli O, Valenta I, Husmann L, Flohr TG, Genoni M, Marincek B, Kaufmann PA, Alkadhi H. Image quality and reconstruction intervals of dual-source CT coronary angiography: recommendations for ECG-pulsing windowing. Invest Radiol. 2007 Aug;42(8):543-9. doi: 10.1097/RLI.0b013e31803b93cf.
Results Reference
background
PubMed Identifier
16607499
Citation
Husmann L, Alkadhi H, Boehm T, Leschka S, Schepis T, Koepfli P, Desbiolles L, Marincek B, Kaufmann PA, Wildermuth S. Influence of cardiac hemodynamic parameters on coronary artery opacification with 64-slice computed tomography. Eur Radiol. 2006 May;16(5):1111-6. doi: 10.1007/s00330-005-0110-4. Epub 2006 Jan 28.
Results Reference
background
PubMed Identifier
15167102
Citation
Lembcke A, Wiese TH, Schnorr J, Wagner S, Mews J, Kroencke TJ, Enzweiler CN, Hamm B, Taupitz M. Image quality of noninvasive coronary angiography using multislice spiral computed tomography and electron-beam computed tomography: intraindividual comparison in an animal model. Invest Radiol. 2004 Jun;39(6):357-64. doi: 10.1097/01.rli.0000123316.10765.6c.
Results Reference
background
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ECG Triggered Dual Source CT for Non-invasive Pre-operative Cardiac Imaging in Morbid Obese Patients
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