跳至主要内容
临床试验/NCT02802579
NCT02802579已完成不适用

ECG Triggered Dual Source CT for Non-invasive Pre-operative Cardiac Imaging in Morbid Obese Patients

Cantonal Hospital of St. Gallen2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2007年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
2
主要终点
coronary artery stenosis

研究概览

简要总结

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.

详细描述

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:

  1. 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).
  2. 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)
  3. 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?
  4. 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.
  5. 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?

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • morbid obesity (BMI >35 kg/m²)
  • intention to undergo bariatric surgery
  • increased risk for coronary artery disease (based on PROCAM score)

排除标准

  • kidney insufficiency (serum creatinine >100 µmol/l, creatinine clearance <50 ml/min)
  • allergy to iodine containing contrast agents
  • hyperthyroidism
  • metformin medication
  • pregnancy

结局指标

主要结局

coronary artery stenosis

时间窗: 7 days

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.

Image quality

时间窗: 7 days

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

次要结局

  • Major adverse cardiovascular events (MACE)(7 years)
  • Signal-to-noise ratio (SNR)(7 days)
  • Image noise(7 days)
  • contrast-to-noise ratio (CNR)(7 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sebastian Leschka, MD

Attending Physician

Cantonal Hospital of St. Gallen

研究点 (2)

Loading locations...

相似试验