ECG Triggered Dual Source CT for Non-invasive Pre-operative Cardiac Imaging in Morbid Obese Patients
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 14, 2016
CompletedFirst Posted
Study publicly available on registry
June 16, 2016
CompletedJune 17, 2016
June 1, 2016
8 years
June 14, 2016
June 16, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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.
7 days
Secondary Outcomes (4)
Image noise
7 days
Signal-to-noise ratio (SNR)
7 days
contrast-to-noise ratio (CNR)
7 days
Major adverse cardiovascular events (MACE)
7 years
Study Arms (3)
A: standard protocol
ACTIVE COMPARATORStandard dual-source computed tomography coronary angiography protocol
B: enhanced protocol
EXPERIMENTALenhanced dual-source computed tomography coronary angiography protocol
C: enhanced obesity protocol
EXPERIMENTALenhanced obesity-mode dual-source computed tomography coronary angiography protocol
Interventions
tube voltage: 120 kV current time product: 350 mAs/rotation rotation: 90° (with two detectors in a 90° angle)
tube voltage: 140 kV current time product: 350 mAs/rotation rotation: 90° (with two detectors in a 90° angle)
tube voltage: 140 kV current time product: 350 mAs/rotation rotation: 180° (with two detectors in a 90° angle)
Eligibility Criteria
You may qualify if:
- morbid obesity (BMI \>35 kg/m²)
- intention to undergo bariatric surgery
- increased risk for coronary artery disease (based on PROCAM score)
You may not qualify if:
- kidney insufficiency (serum creatinine \>100 µmol/l, creatinine clearance \<50 ml/min)
- allergy to iodine containing contrast agents
- hyperthyroidism
- metformin medication
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cantonal Hospital St Gallen
Sankt Gallen, 9007, Switzerland
Related Publications (4)
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.
PMID: 1116248BACKGROUNDLeschka 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.
PMID: 17620936BACKGROUNDHusmann 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.
PMID: 16607499BACKGROUNDLembcke 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.
PMID: 15167102BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sebastian Leschka, MD
Cantonal Hospital of St. Gallen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending Physician
Study Record Dates
First Submitted
June 14, 2016
First Posted
June 16, 2016
Study Start
December 1, 2007
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
June 17, 2016
Record last verified: 2016-06
Data Sharing
- IPD Sharing
- Will not share