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

Cantonal Hospital of St. Gallen

Status: Completed

Conditions: Obesity, Morbid

Treatments: Radiation: enhanced protocol; Radiation: enhanced obesity protocol; Radiation: standard protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT02802579

RAD0701

Details and patient eligibility

About

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.

Full 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:

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?

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 3 patient groups

A: standard protocol

Active Comparator group

Description:

Standard dual-source computed tomography coronary angiography protocol

Treatment:

Radiation: standard protocol

B: enhanced protocol

Experimental group

Description:

enhanced dual-source computed tomography coronary angiography protocol

Treatment:

Radiation: enhanced protocol

C: enhanced obesity protocol

Experimental group

Description:

enhanced obesity-mode dual-source computed tomography coronary angiography protocol

Treatment:

Radiation: enhanced obesity protocol